Product Recall Alerts: America's Unsafe Medical Products

The U.S. Food and Drug Administration (FDA) issued two new safety alerts in the past two weeks. Both are recalls, including one Class I recall for a ...
Read more: America's Unsafe Medical Products

US FDA News: Aurobindo Pharma USA, Inc. Issues Voluntary Nationwide Recall of Mirtazapine Tablets Lot Number 03119002A3 Due to Label Error on Declared Strength

Aurobindo Pharma USA, Inc. is voluntarily recalling lot number 03119002A3 of Mirtazapine Tablets to the consumer level. The product is being recalled due to a label error on declared strength; bottles labeled as Mirtazapine 7.5 mg may contain 15 mg tablets.
Read more: Aurobindo Pharma USA, Inc. Issues Voluntary Nationwide Recall of Mirtazapine Tablets Lot Number 03119002A3 Due to Label Error on Declared Strength

Pharma Reviews: New Year 2020: After a turbulent decade, pharma sector prays for calmer waters

Most in the Indian pharma industry are hopeful that the new National List of Essential Medicines (NLEM) expected in 2020 will not be too disruptive.
Read more: New Year 2020: After a turbulent decade, pharma sector prays for calmer waters

Pharma Reviews: Universal Health Care Act presents opportunities for Indian pharma firms in Philippines: GlobalData

India was found by the data analytics company to be the top import partner of the Philippines in 2018, contributing 12.6 per cent of the total ...
Read more: Universal Health Care Act presents opportunities for Indian pharma firms in Philippines: GlobalData

Pharma Reviews: Exciting opportunities emerge for Indian pharma firms in the Philippines

Exciting opportunities emerge for Indian pharma firms in the Philippines ... Act presents exciting opportunities for the Indian pharmaceutical industry.
Read more: Exciting opportunities emerge for Indian pharma firms in the Philippines

Pharma Reviews: Indian pharma, healthcare sector poised for another year of robust growth

“The Indian Pharmaceutical industry is a sunrise industry with a competitive advantage for India. We should leverage India's position by unleashing ...
Read more: Indian pharma, healthcare sector poised for another year of robust growth

Pharma Reviews: Exciting opportunities emerge for Indian pharma firms in the Philippines

She added that "while the innovator pharmaceutical space in the country is dominated by the subsidiaries of key US and EU companies, India can ...
Read more: Exciting opportunities emerge for Indian pharma firms in the Philippines

Pharma Reviews: 2020: Indian pharma 'sunrise' segment, prognosis positive for healthcare sector

New Delhi, Dec 28 (PTI) Nourished by increasing spending, improving accessibility and growing exports, India's pharma and healthcare sector is ...
Read more: 2020: Indian pharma 'sunrise' segment, prognosis positive for healthcare sector

Pharma Reviews: 2020: Indian pharma 'sunrise' segment, prognosis positive for healthcare sector

NEW DELHI, Dec 28: Nourished by increasing spending, improving accessibility and growing exports, India's pharma and healthcare sector is poised ...
Read more: 2020: Indian pharma 'sunrise' segment, prognosis positive for healthcare sector

Pharma Reviews: Indian Pharma 'Sunrise' Segment, Year 2020 Prognosis Positive For Healthcare Sector

"The Indian Pharmaceutical industry is a sunrise industry with a competitive advantage for India. We should leverage India's position by unleashing ...
Read more: Indian Pharma 'Sunrise' Segment, Year 2020 Prognosis Positive For Healthcare Sector

Pharma Reviews: Fedco ties up with Power Sector Skill Council to train industry workforce

“Fedco's contribution to the skill development program on an all India basis has been ... Through this partnership, power sector professionals and interested ... Indian pharma 'sunrise' segment, prognosis positive for healthcare sector.
Read more: Fedco ties up with Power Sector Skill Council to train industry workforce

Pharma Reviews: 2020: Indian pharma 'sunrise' segment, prognosis positive for healthcare sector

NEW DELHI: Nourished by increasing spending, improving accessibility and growing exports, India's pharma and healthcare sector is poised for ...
Read more: 2020: Indian pharma 'sunrise' segment, prognosis positive for healthcare sector

Pharma Reviews: Year in review: In 2019, Indian pharma battled regulatory scare, and won

The year 2019 has been an eventful one for Indian pharma. Apart from regulatory scares from its key export market, the US, and the lookout for ...
Read more: Year in review: In 2019, Indian pharma battled regulatory scare, and won

Pharma Reviews: Pharmexcil to host iPHEX in Noida in May

Hyderabad: Pharmaceutical Export Promotion Council of India (Pharmexcil) will be hosting International Pharmaceuticals and Healthcare Exhibition ...
Read more: Pharmexcil to host iPHEX in Noida in May

Pharma Reviews: Five things to watch out for in pharma and healthcare in 2020

The domestic formulation business has now become a key driver of growth for Indian companies. In 2019 the Indian pharmaceutical market grew at 10 ...
Read more: Five things to watch out for in pharma and healthcare in 2020

Pharma Reviews: Study claims neurologists took pharma sponsored trip with South Indian actresses, Medical ...

... neurologists from Mumbai, who were allegedly sponsored by a pharma company for a foreign trip with two South Indian actresses, the Maharashtra ...
Read more: Study claims neurologists took pharma sponsored trip with South Indian actresses, Medical ...

Pharma Reviews: Lupin Ankleshwar facility wins India Manufacturing Excellence Awards 2019

Lupin is the eighth largest generics pharmaceutical company by revenues and third-largest Indian pharmaceutical company. For the financial year ...
Read more: Lupin Ankleshwar facility wins India Manufacturing Excellence Awards 2019

Pharma Reviews: Govt warns pharma firms after report says doctors bribed with women, foreign trips, gadgets

At a review meeting on 23 December with three drugmaker associations — Indian Drug Manufacturers' Association (IDMA), Indian Pharmaceutical ...
Read more: Govt warns pharma firms after report says doctors bribed with women, foreign trips, gadgets

Pharma Reviews: 2020's multibaggers will most likely come from these sectors

Blue chips continued to outpace the broader market for the second straight .... In the pharma space, shares of Astrazeneca Pharma, Abbott India and ...
Read more: 2020's multibaggers will most likely come from these sectors

Pharma Reviews: "If There's an Element of Failure, Try to Fail Fast"

Yet, the world's 14th largest pharma company faces multiple challenges, two ... We are using digital tools - in India it is called AI - which is very good to ...
Read more: "If There's an Element of Failure, Try to Fail Fast"

Pharma Reviews: Lupin's Ankleshwar Cacility Wins Frost & Sullivan's India Manufacturing Excellence Awards 2019

Pharma major Lupin Ltd said on Tuesday that its Ankleshwar facility has been awarded 'Future Ready Factory of the Year' by Frost & Sullivan's India ...
Read more: Lupin's Ankleshwar Cacility Wins Frost & Sullivan's India Manufacturing Excellence Awards 2019

Pharma Reviews: Lupin's Ankleshwar cacility wins Frost & Sullivan's India manufacturing excellence awards 2019

Mumbai (Maharashtra) [India], Dec 24 (ANI): Pharma major Lupin Ltd said on Tuesday that its Ankleshwar facility has been awarded 'Future Ready ...
Read more: Lupin's Ankleshwar cacility wins Frost & Sullivan's India manufacturing excellence awards 2019

Pharma Reviews: Elpro City Square Mall brings in Christmas joy with 'The City Festival'

Pune (Maharashtra) [India], Dec 24 (ANI/NewsVoir): The City Festival at Elpro City Square Mall, Chinchwad, Pune, ended ... The 2019 evaluation for pharmaceutical sector large business was done on the basis of an organisations' ...
Read more: Elpro City Square Mall brings in Christmas joy with 'The City Festival'

Pharma Reviews: Lupin's Ankleshwar Cacility Wins Frost & Sullivan's India Manufacturing Excellence Awards 2019

The 2019 evaluation for pharmaceutical sector large business was done on the basis of an organisations' manufacturing capability, extended supply ...
Read more: Lupin's Ankleshwar Cacility Wins Frost & Sullivan's India Manufacturing Excellence Awards 2019

Pharma Reviews: India starts probe into alleged dumping of chemical from China

NEW DELDI: India has initiated a probe into alleged dumping of a chemical, used in dye and pharma industry, from China following a complaint by a ...
Read more: India starts probe into alleged dumping of chemical from China

US FDA News: Mavidon Issues Voluntary Worldwide Recall of all Manufactured Products Due to Burkholderia cepacia Contamination

Mavidon is voluntarily recalling all lots of products manufactured at our facility including LemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups, Cardio Prep and Collodions, Collodion removers due to contamination with Burkholderia cepacia.
Read more: Mavidon Issues Voluntary Worldwide Recall of all Manufactured Products Due to Burkholderia cepacia Contamination

US FDA News: FDA approves first generics of Eliquis

The U.S. Food and Drug Administration today approved two applications for first generics of Eliquis (apixaban) tablets.
Read more: FDA approves first generics of Eliquis

US FDA News: FDA approves new treatment for adults with migraine

FDA approves Ubrelvy (ubrogepant) tablets for the acute treatment of migraine with or without aura in adults.
Read more: FDA approves new treatment for adults with migraine

Pharma Reviews: 2020 to prove disappointing for Indian pharma: Amit Rajan

2020 is going to disappoint Indian pharma sector further, not because we are going to make more mistakes and number of ANDA filings are going to ...
Read more: 2020 to prove disappointing for Indian pharma: Amit Rajan

Product Recall Alerts: America's Unsafe Medical Products

There are several types of alerts, including letters to health care providers, warnings to users, drug safety notices and recalls. The most serious alert is ...
Read more: America's Unsafe Medical Products

Pharma Reviews: Honeywell opens packaging lab

Akshay Bellare, president, Honeywell India, unveiled the laboratory. ... Given the expected growth of pharmaceutical packaging market by 2023, ...
Read more: Honeywell opens packaging lab

Pharma Reviews: Indian bio-pharmaceutical industry to touch INR 3000 billion by 2023 -claims a study

As per the recent study, the Indian bio-pharmaceuticals market is expected to touch around INR 3000 Billion by 2023. Research by ...
Read more: Indian bio-pharmaceutical industry to touch INR 3000 billion by 2023 -claims a study

Pharma Reviews: Now Indian drug standards reach foreign labs; this country is first to adapt

India's pharmaceutical industry has got a reason to cheer after Afghanistan recognised the Indian Pharmacopoeia (IP) – Indian standards of drugs ...
Read more: Now Indian drug standards reach foreign labs; this country is first to adapt

Pharma Reviews: India's price control policy has destroyed drug manufacturers. This is how they can be saved

India's price control policy has destroyed drug manufacturers. ... Instead of existing price control mechanisms, the Indian government needs to find ...
Read more: India's price control policy has destroyed drug manufacturers. This is how they can be saved

US FDA News: FDA expands indication for continuous glucose monitoring system, first to replace fingerstick testing for diabetes treatment decisions

The U.S. Food and Drug Administration today expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment decisions in people 2 years of age and older with diabetes.
Read more: FDA expands indication for continuous glucose monitoring system, first to replace fingerstick testing for diabetes treatment decisions

US FDA News: FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies

FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting
Read more: FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies

Pharma Reviews: Uflex highlights its pharma packaging solutions at CPHI 2019

Ashok Chaturvedi, chairman and managing director, Uflex, said, “CPHI is widely used as a barometer of the pharma industry in India. Being one of the ...
Read more: Uflex highlights its pharma packaging solutions at CPHI 2019

Pharma Reviews: Innovation and regulatory harmonisation to drive Indian pharma in 2020

CPhI & P-MEC India 2019 growth mirrors the market's positive outlook heading into 2020 This year's edition saw a rise in overall attendees, with ...
Read more: Innovation and regulatory harmonisation to drive Indian pharma in 2020

US FDA News: FDA, DEA seize 44 websites advertising sale of illicit THC vaping cartridges to US consumers as part of Operation Vapor Lock

The FDA and the Drug Enforcement Administration have seized 44 websites advertising the sale of illicit THC vaping cartridges.
Read more: FDA, DEA seize 44 websites advertising sale of illicit THC vaping cartridges to US consumers as part of Operation Vapor Lock

US FDA News: LivaNova Recalls VNS Therapy SenTiva Generator Due to Reset Error

LivaNova is recalling the VNS Therapy SenTiva Generator System due to an unintended reset error that causes the system to stop delivering VNS therapy.
Read more: LivaNova Recalls VNS Therapy SenTiva Generator Due to Reset Error

Pharma Reviews: Karnataka: A 35-year-old woman bus conductor attacked with acid by unidentified miscreants

She is currently receiving medical treatment at a private hospital and a case in the ... Indian pharma sector should learn from China: Pankaj Patel.
Read more: Karnataka: A 35-year-old woman bus conductor attacked with acid by unidentified miscreants

Pharma Reviews: New Year goal: hit the gym, eat healthy. What could spoil it? Dodgy supplements and weak ...

Last July, the agency nudged the Confederation of Indian Industry to ... “Since health supplements are not medicines, the FSSAI has to constantly ...
Read more: New Year goal: hit the gym, eat healthy. What could spoil it? Dodgy supplements and weak ...

Pharma Reviews: FDI in manufacturing to drive Indian economic growth next decade: Sunil Subramaniam

The last 10 years are being called the lost decade in India. In a lost .... We will tend to have an export surplus and IT and pharma companies will also ...
Read more: FDI in manufacturing to drive Indian economic growth next decade: Sunil Subramaniam

US FDA News: Neurontin, Gralise, Horizant (gabapentin) and Lyrica, Lyrica CR (pregabalin): Drug Safety Communication - Serious Breathing Problems

FDA is warning that serious breathing difficulties may occur in patients using gabapentin or pregabalin who have respiratory risk factors.
Read more: Neurontin, Gralise, Horizant (gabapentin) and Lyrica, Lyrica CR (pregabalin): Drug Safety Communication - Serious Breathing Problems

US FDA News: First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response

FDA announced today the approval of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older.
Read more: First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response

US FDA News: Lannett Issues Voluntary Nationwide Recall Of Levetiracetam Oral Solution, 100mg/Ml Due To Microbial Contamination

Lannett Company, Inc. today announced that it is voluntarily recalling two (2) lots of Levetiracetam Oral Solution, 100mg/mL to the consumer level due to contamination with Bacillus subtilis. The Bacillus subtilis was identified during an evaluation of a raw material used to manufacture the product
Read more: Lannett Issues Voluntary Nationwide Recall Of Levetiracetam Oral Solution, 100mg/Ml Due To Microbial Contamination

US FDA News: FDA takes efforts to improve quality of compounded drugs from outsourcing facilities through collaboration and education as part of new Center of Excellence

Today, the agency is announcing the Compounding Quality Center of Excellence – an initiative designed to improve the overall quality of compounded medicines.
Read more: FDA takes efforts to improve quality of compounded drugs from outsourcing facilities through collaboration and education as part of new Center of Excellence

US FDA News: Smiths Medical ASD, Inc. Recalls Medfusion® 4000 Syringe Pumps Due to Malfunctioning Alarms and Potential Interruption of Therapy

The software updates could cause alarms to stop working and cause the battery to drain without warning and potentially interrupt therapy, which could lead to serious injury or death.
Read more: Smiths Medical ASD, Inc. Recalls Medfusion® 4000 Syringe Pumps Due to Malfunctioning Alarms and Potential Interruption of Therapy

Pharma Reviews: Indian pharma sector should learn from China: Pankaj Patel

“The overall cost of AIDS treatment went down by 60 per cent because of Indian manufacturers. Today most of the vaccines supplied for the global ...
Read more: Indian pharma sector should learn from China: Pankaj Patel

Pharma Reviews: In the economics of health

Icra said in a statement that "The domestic pharmaceutical industry has ... "The growth was supported by higher market share for Indian players as ...
Read more: In the economics of health

Pharma Reviews: Here's what transpired in the Indian pharma and healthcare industry in 2019

The year 2019 has been an action-packed one for pharmaceutical and healthcare sectors, with the USFDA warning letters and government policy ...
Read more: Here's what transpired in the Indian pharma and healthcare industry in 2019

US FDA News: Statement on National Academies of Sciences, Engineering, and Medicine report on framing opioid prescribing guidelines for acute pain

National Academies of Sciences, Engineering, and Medicine (NASEM) was tasked with providing a framework to evaluate current and future opioid prescribing to support a clinical practice guideline and to identify gaps in the evidence.
Read more: Statement on National Academies of Sciences, Engineering, and Medicine report on framing opioid prescribing guidelines for acute pain

Pharma Reviews: Indian pharma sector to grow at 10-12 pc during FY19-22, says ICRA

New Delhi: The rating agency Icra on Wednesday said the Indian pharmaceutical industry is expected to grow around 10-12 per cent between FY2019 ...
Read more: Indian pharma sector to grow at 10-12 pc during FY19-22, says ICRA

Pharma Reviews: Indian pharma sector to grow at 10-12 % during FY19-22: Icra

Indian pharmaceutical industry is expected to grow around 10-12 per cent between FY2019 and FY2022 while maintaining a stable outlook on the ...
Read more: Indian pharma sector to grow at 10-12 % during FY19-22: Icra

Pharma Reviews: Why Indian Units Of Pharma MNCs Are Emerging As A Safe Bet For Investors

CLSA said India's Indian pharmaceutical market is estimated to grow from $19.5-billion to $55 billion in 10 years. That growth, according to the ...
Read more: Why Indian Units Of Pharma MNCs Are Emerging As A Safe Bet For Investors

Pharma Reviews: Stocks to Watch: Tata Group, InterGlobe Aviation, RIL, L&T Finance

Pharma stocks: Ratings agency ICRA has maintained a stable outlook on the Indian pharmaceutical industry. The abating headwinds from pricing ...
Read more: Stocks to Watch: Tata Group, InterGlobe Aviation, RIL, L&T Finance

Pharma Reviews: Analyst corner: Pharma market reports 14.5% growth in November

Indian pharmaceutical market's (IPM) growth recovered impressively to 14.5% YoY in November from 5.1% YoY in the previous month.
Read more: Analyst corner: Pharma market reports 14.5% growth in November

Pharma Reviews: Visa case: Infosys settles lawsuit in US with payout of $800000

"Just like the pharma industry getting observations from (the US sector regulator), the Indian IT industry is facing visa-related lawsuits. These are not ...
Read more: Visa case: Infosys settles lawsuit in US with payout of $800000

US FDA News: FDA approves new type of therapy to treat advanced urothelial cancer

FDA granted accelerated approval to Padcev, a Nectin-4-directed antibody and microtubule inhibitor conjugate, meaning the drug specifically targets cancer cells – in this case, the cell adhesion molecule Nectin-4 which is highly expressed in urothelial cancers
Read more: FDA approves new type of therapy to treat advanced urothelial cancer

Pharma Reviews: How Pune-based Cilicant is trying to disrupt MNC-dominated pharma desiccant market

Until then, Indian pharma industry would continue buying from two multinationals-- US-based Multisorb and Switzerland-based Clariant Specialty ...
Read more: How Pune-based Cilicant is trying to disrupt MNC-dominated pharma desiccant market

Pharma Reviews: ICRA projects Indian pharma sector growth at 10-12 % during FY19-22

ICRA said that FY2019-2022 compound annual growth rate (CAGR) is expected to be around 10-12 per cent for domestic pharmaceutical companies.
Read more: ICRA projects Indian pharma sector growth at 10-12 % during FY19-22

US FDA News: Trump Administration takes historic steps to lower U.S. prescription drug prices

The Trump Administration is taking steps to lower prescription drug prices by proposing a rule that could allow for the importation of certain drugs from Canada and issuing draft guidance explaining how manufacturers could import drugs, biological products originally intended for sale abroad.
Read more: Trump Administration takes historic steps to lower U.S. prescription drug prices

Pharma Reviews: Swiss' daily Zurich-Washington service is good news for Indian pharma: Andres L Perez

The Airbus A330-300 flying between Zurich and Washington DC from March 29, 2019, will be good news from Indian pharma industry as Swiss will be ...
Read more: Swiss' daily Zurich-Washington service is good news for Indian pharma: Andres L Perez

Pharma Reviews: Indian pharma sector expected to grow at 10-12 pc during FY19-22, outlook stable: Icra

New Delhi, Dec 18 () Ratings agency Icra on Wednesday said the Indian pharmaceutical industry is expected to grow around 10-12 per cent between ...
Read more: Indian pharma sector expected to grow at 10-12 pc during FY19-22, outlook stable: Icra

Pharma Reviews: Drug price increase: Who gains big, what it means for the industry

Drug price increase: Who gains big, what it means for the industry .... The regulatory move has a rub-off on Indian pharma companies, too. Ipca labs ...
Read more: Drug price increase: Who gains big, what it means for the industry

Pharma Reviews: Deals Buzz: Fashion platform Zilingo acquires nCinga Innovations for $15.5 mn

India's private equity and venture capital industry is asking that domestic ... After selling it its India pharma business to US drug maker Abbott for ...
Read more: Deals Buzz: Fashion platform Zilingo acquires nCinga Innovations for $15.5 mn

Pharma Reviews: Piramal enterprises looks to sell 20% equity in healthcare business

After selling its India pharma business to US drug maker Abbott for Rs 17,000 crore a decade ago and expanding to sectors such as real estate and ...
Read more: Piramal enterprises looks to sell 20% equity in healthcare business

Pharma Reviews: Lupin announces completion of Kyowa divestiture to Unison

Mumbai: Pharma major Lupin Ltd said on Tuesday that its subsidiary ... It is the third largest Indian pharmaceutical company by global revenues with ...
Read more: Lupin announces completion of Kyowa divestiture to Unison

Pharma Reviews: Lupin arm Nanomi BV completes Kyowa divestiture to Unison

Mumbai: Pharma major Lupin Ltd said on Tuesday that its subsidiary ... It is the third-largest Indian pharmaceutical company by global revenues with ...
Read more: Lupin arm Nanomi BV completes Kyowa divestiture to Unison

US FDA News: Glenmark Pharmaceuticals Inc., USA Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

Glenmark Pharmaceutical Inc., USA (“Glenmark”) today announced the voluntary recall of all unexpired lots of Ranitidine Tablets, 150 mg and 300 mg, to the consumer level.
Read more: Glenmark Pharmaceuticals Inc., USA Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

US FDA News: Statement on low-cost biosimilar and interchangeable protein products

FDA statement on low-cost biosimilar and interchangeable protein products
Read more: Statement on low-cost biosimilar and interchangeable protein products

US FDA News: Motto International Corp. Issues Voluntary Recall of Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, and Panther Platinum 30000, Due to Presence of Undeclared Tadalafil

Motto International Corp. is voluntarily recalling all lots of Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, and Panther Platinum 30000, to the consumer level.
Read more: Motto International Corp. Issues Voluntary Recall of Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, and Panther Platinum 30000, Due to Presence of Undeclared Tadalafil

US FDA News: GE Healthcare Recalls Giraffe Incubators and OmniBeds Due to Potential for Infants to Fall

The bedside panels and portholes can appear closed without being latched, no longer protect the infant from falling.
Read more: GE Healthcare Recalls Giraffe Incubators and OmniBeds Due to Potential for Infants to Fall

Product Recall Alerts: Another manufacturer recalls ranitidine products over NDMA contamination

The Medicines and Healthcare products Regulatory Agency issued a drug alert, on 16 December 2019, recalling ranitidine 150mg and 300mg tablets ...
Read more: Another manufacturer recalls ranitidine products over NDMA contamination

Pharma Reviews: India emerges as a hub for biotech drug research, says report

The Indian pharmaceutical companies always had strong chemistry skills to work on small molecules to make generic drugs, but they lacked skills, ...
Read more: India emerges as a hub for biotech drug research, says report

US FDA News: Cook Medical Recalls CrossCath® Support Catheters Due to a Manufacturing Error Which May Cause the Marker Bands to Dislodge or Cause Buckling

FDA classifies Class I recall for Cook Medical CrossCath® Support Catheters due to radiopaque marker bands being too loose or too tight on certain catheters.
Read more: Cook Medical Recalls CrossCath® Support Catheters Due to a Manufacturing Error Which May Cause the Marker Bands to Dislodge or Cause Buckling

US FDA News: FDA permits sale of two new reduced nicotine cigarettes through premarket tobacco product application pathway

FDA permits sale of two new reduced nicotine cigarettes through premarket tobacco product application pathway
Read more: FDA permits sale of two new reduced nicotine cigarettes through premarket tobacco product application pathway

Pharma Reviews: This is the only pharmaceutical stock that has given over 100% returns in 2019

Despite all these negative factors in the sector, stock of AstraZeneca Pharma India, a midcap pharmaceutical company, has outperformed all its peers ...
Read more: This is the only pharmaceutical stock that has given over 100% returns in 2019

Pharma Reviews: Share Market Update: Indices log highest closing ever; Sensex ends 413 points higher, Nifty at ...

Share Market Update:Indian benchmark indices Sensex and Nifty rose 1% each by ... In terms of sector, except pharma and realty, all major sector-based indices ... Shares of NBCC India rose 3% in Tuesday's trade after the company ...
Read more: Share Market Update: Indices log highest closing ever; Sensex ends 413 points higher, Nifty at ...

Pharma Reviews: Prof. Shamnad Basheer & Justice Ravindra Bhat Amongst 50 Most Influential People in IP 2019

(Dr.) Shamnad Basheer and Justice S. Ravindra Bhat are the two Indians ... wherein Roche's plea to injunct Cipla from marketing a lung cancer drug ...
Read more: Prof. Shamnad Basheer & Justice Ravindra Bhat Amongst 50 Most Influential People in IP 2019

Pharma Reviews: Lupin Announces Completion Of Kyowa Divestiture To Unison

It is the third-largest Indian pharmaceutical company by global revenues with consolidated sales and net profits before exceptional items totalling Rs ...
Read more: Lupin Announces Completion Of Kyowa Divestiture To Unison

Pharma Reviews: Allowing drug-price hikes good, but junking price caps real solution

The decision of the drug-price regulator, the National Pharmaceutical ... Apart from import-dependence, the price caps have also pushed Indian ...
Read more: Allowing drug-price hikes good, but junking price caps real solution

US FDA News: Medtronic Recalls SynchroMed II Implantable Drug Infusion Pump Due to the Potential Presence of Foreign Particles Inside the Pump Motor Assembly Which May Lead to a Pump Motor Stall

Medtronic received reports of early permanent motor stall due to the presence of foreign particles. Permanent motor stall could lead to serious injury or death.
Read more: Medtronic Recalls SynchroMed II Implantable Drug Infusion Pump Due to the Potential Presence of Foreign Particles Inside the Pump Motor Assembly Which May Lead to a Pump Motor Stall

Pharma Reviews: With valuations rich elsewhere, is it time to swallow the bitter pill?

In recent times, rising revenues in the domestic market have been helping Indian pharma companies make up for the ongoing pricing pressure on ...
Read more: With valuations rich elsewhere, is it time to swallow the bitter pill?

Pharma Reviews: Economy may not improve much but global cues to drive markets in 2020: Ajay Srivastava

But if you are expecting a better 2020 for the stock market, overseas developments are going to be .... Indian pharma companies are yet to turn around.
Read more: Economy may not improve much but global cues to drive markets in 2020: Ajay Srivastava

Pharma Reviews: A band-aid

Last week, India's drug regulator, the National Pharmaceutical Pricing Authority (NPPA), used the public interest provision of the Drugs Prices Control ...
Read more: A band-aid

Pharma Reviews: Key medicines likely to get costlier soon

The NPPA's move is in response to the pharma industry's requests over the last two ... The industry had sought a hike in the wake of rising prices of active ... Recently, a PwC India report which noted the increase in API prices as high ...
Read more: Key medicines likely to get costlier soon

US FDA News: FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups

FDA expands the indication of Vascepa (icosapent ethyl) capsules to reduce the risk of cardiovascular events as an adjunct to maximally tolerated statin therapy in high-risk adult patients with elevated triglyceride levels. It is a fish oil-derived omega-3 fatty acid product indicated to reduce the
Read more: FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups

US FDA News: FDA clears first fully disposable duodenoscope, eliminating the potential for infections caused by ineffective reprocessing

The FDA today cleared for marketing in the U.S. the first fully disposable duodenoscope. The EXALT Model D Single-Use Duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems.
Read more: FDA clears first fully disposable duodenoscope, eliminating the potential for infections caused by ineffective reprocessing

Pharma Reviews: Capex Formula

... that pharma companies have been facing, especially those in India - pricing ... "The API manufacturing space in India had been experiencing stiff ...
Read more: Capex Formula

US FDA News: FDA authorizes first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customize their individual diabetes management device system

The FDA has authorized marketing of an interoperable automated glycemic controller device that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM).
Read more: FDA authorizes first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customize their individual diabetes management device system

Pharma Reviews: VisionHealth2024: Roadmap of Healthy, Happy and Empowered India

The healthcare industry is one of the fastest growing sectors in India, ... 100 percent FDI for pharma sector, medical device parks, and setting up of ...
Read more: VisionHealth2024: Roadmap of Healthy, Happy and Empowered India

US FDA News: FDA grants accelerated approval to first targeted treatment for rare Duchenne muscular dystrophy mutation

Today, the FDA approved a new treatment for Vyondys 53 (golodirsen) injection to treat Duchenne muscular dystrophy (DMD) patients
Read more: FDA grants accelerated approval to first targeted treatment for rare Duchenne muscular dystrophy mutation

US FDA News: Statement on new findings and current status of the romaine lettuce E. coli O157:H7 outbreak investigation

Illnesses subsiding, FDA continues to aggressively investigate source and route of contamination to prevent future outbreaks
Read more: Statement on new findings and current status of the romaine lettuce E. coli O157:H7 outbreak investigation

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand access

FDA is announcing a public hearing to discuss access to affordable insulin products.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to bring competition to the insulin market to lower prices and expand access

US FDA News: FDA authorizes first test to aid in newborn screening for Duchenne Muscular Dystrophy

Today, the U.S. Food and Drug Administration authorized marketing of the first test to aid in newborn screening for Duchenne Muscular Dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness.
Read more: FDA authorizes first test to aid in newborn screening for Duchenne Muscular Dystrophy

Pharma Reviews: Switzerland to Partner India for BioAsia 2020

Hyderabad: Seeking closer ties with Indian life sciences industry, ... big pharma with the presence of eminent pharma and life-sciences companies like ...
Read more: Switzerland to Partner India for BioAsia 2020

US FDA News: Public Safety Alert Due to Marketing of Unapproved Stem Cell and Exosome Products

FDA is informing the public, especially patients, health care practitioners, and clinics, of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes.
Read more: Public Safety Alert Due to Marketing of Unapproved Stem Cell and Exosome Products

Pharma Reviews: Pharma companies seek hike in drug rates under price control

At a meeting on Wednesday, industry lobby groups like Federation of Pharmaceutical Entrepreneurs (FOPE), Indian Pharmaceutical Alliance and ...
Read more: Pharma companies seek hike in drug rates under price control

Pharma Reviews: Pharma market grows 14.5% in November, respiratory drugs lead

The Indian pharmaceutical market (IPM) expanded 14.5 percent in November led by strong sales growth of anti-infectives and respiratory drugs.
Read more: Pharma market grows 14.5% in November, respiratory drugs lead

US FDA News: FDA issues warning letter for not including the most serious risks in advertisement for medication-assisted treatment drug

FDA issues warning letter to Alkermes, Inc., for misbranding the drug Vivitrol (an extended-release injection formulation of naltrexone) by omitting warnings about the most serious risks associated with the drug from promotional materials
Read more: FDA issues warning letter for not including the most serious risks in advertisement for medication-assisted treatment drug

Pharma Reviews: Telangana eyes USD 100 billion revenues from pharma, medical technology industries

The European country is looking to forge closer ties with India which has grown into a significant player in life sciences industry globally and has now ...
Read more: Telangana eyes USD 100 billion revenues from pharma, medical technology industries

Pharma Reviews: Switzerland partners with BioAsia2020; seeks closer ties with Indian Lifesciences industry

Hyderabad: Switzerland, consistently ranked no.1 in innovation, is widely known for innovation in big pharma with the presence of eminent pharma ...
Read more: Switzerland partners with BioAsia2020; seeks closer ties with Indian Lifesciences industry

US FDA News: Public Safety Alert Due to Marketing of Unapproved Stem Cell and Exosome Products

FDA is informing the public, especially patients, health care practitioners, and clinics, of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes.
Read more: Public Safety Alert Due to Marketing of Unapproved Stem Cell and Exosome Products

US FDA News: FDA underscores that consumers should not use drugs, dietary supplements and devices recalled from Basic Reset and Biogenyx following consent decree for federal violations

The U.S. Food and Drug Administration is alerting consumers of a recall of 25 drug, dietary supplement and medical device product lines distributed by Basic Reset and Biogenyx.
Read more: FDA underscores that consumers should not use drugs, dietary supplements and devices recalled from Basic Reset and Biogenyx following consent decree for federal violations

Pharma Reviews: With Vildagliptin off-patent from today, new doors open for pharma players

It is expected to start selling the drug for type-2 diabetes in the Indian market from today. Also Read: Eris Lifesciences acquires diabetes drug ...
Read more: With Vildagliptin off-patent from today, new doors open for pharma players

Pharma Reviews: Generic drugs revisited

In conversations with many western pharmaceutical managers, I have often told them that it is not fair that a poor country like India pay actuals for ...
Read more: Generic drugs revisited

Pharma Reviews: Beyond trade margin caps, patient groups call for legal oversight of pharma marketing, promotion

The UCPMP is a code of marketing practices for the Indian pharma industry which was to be voluntarily adopted and implemented from January 1, ...
Read more: Beyond trade margin caps, patient groups call for legal oversight of pharma marketing, promotion

Pharma Reviews: Price of diabetes drug to halve soon as cheap versions of top drug to hit market

MUMBAI: There is some good news for the over 72 million diabetics in India, with a cheaper version of a blockbuster drug hitting the market on ...
Read more: Price of diabetes drug to halve soon as cheap versions of top drug to hit market

Pharma Reviews: Medicine sales rise 14.5% in Nov, Indian pharma firms lead growth

NEW DELHI, PHARMACEUTICAL SALES : A low base coupled with an early festival season helped pharmaceutical sales rise 14.5% year-on-year to ...
Read more: Medicine sales rise 14.5% in Nov, Indian pharma firms lead growth

Pharma Reviews: How equity investors should play the falling GDP scenario

“Due to several structural issues faced by the Indian economy, growth rate is ... The entire pharma industry can be treated as a defensive bet now because their ... Domestic woes will not affect pharmaceutical companies like Cipla.
Read more: How equity investors should play the falling GDP scenario

US FDA News: FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk

FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk
Read more: FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk

US FDA News: Statement from Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on impurities found in diabetes drugs outside the U.S.

The FDA is investigating whether metformin in the U.S. market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms.
Read more: Statement from Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on impurities found in diabetes drugs outside the U.S.

US FDA News: FDA approves first generics of Gilenya

The U.S. Food and Drug Administration today approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients
Read more: FDA approves first generics of Gilenya

US FDA News: FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria

Today, the U.S. Food and Drug Administration authorized marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a widespread cause of hospital-acquired infections. The cobas vivoDx MRSA
Read more: FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria

US FDA News: FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases

FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases
Read more: FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases

Pharma Reviews: Mankind Pharma launches drug for treatment of infertility in India

NEW DELHI: Drug firm Mankind Pharma on Thursday said it has launched its generic Dydrogesterone tablets for treatment of infertility and pregnancy ...
Read more: Mankind Pharma launches drug for treatment of infertility in India

Pharma Reviews: Indian industry disappointed by RBI's decision to leave rates unchanged

He said a rate cut was “important for boosting the sentiment in the market ... Meanwhile, a senior executive of the pharmaceutical industry said RBI's ...
Read more: Indian industry disappointed by RBI's decision to leave rates unchanged

Pharma Reviews: Centre crackdown puts e-pharma firms in the soup

Industry executives say the e-pharma sector caters to about 50 lakh patients per month across India and employs around 30,000 skilled professionals.
Read more: Centre crackdown puts e-pharma firms in the soup

Pharma Reviews: This Fledgling Online Market Too Is Facing Brick-And-Mortar Backlash In India

Suraj Srivastava, 45, didn't get the right medicines when he placed an order for his father's drugs on Medlife, an online pharmacy. He not only had to ...
Read more: This Fledgling Online Market Too Is Facing Brick-And-Mortar Backlash In India

Pharma Reviews: "Delay in notification of rules affecting e-pharma industry''

New Delhi: The e-pharmacy industry has urged the government for ... the e-Pharmacy sector has attracted over US$ 500 million from Indian Private ...
Read more: "Delay in notification of rules affecting e-pharma industry''

Pharma Reviews: Swedish firms interested in Ayushman Bharat data to develop new medicines in India

New Delhi, Dec 3 (PTI) The scale of Modi government's flagship Ayushman Bharat has attracted Swedish pharmaceutical industry which is exploring ...
Read more: Swedish firms interested in Ayushman Bharat data to develop new medicines in India

Pharma Reviews: Lupin wins award for 'Operational Excellence in Manufacturing'

Lupin has won the prestigious award for 'Operational Excellence in Manufacturing' at the India Pharma Awards 2019. The jury panel which comprised ...
Read more: Lupin wins award for 'Operational Excellence in Manufacturing'

Pharma Reviews: 13th CPhI and P-MEC India Expo showcased the glory of Indian pharmaceutical space

The 13th edition of CPhI and P-MEC event showcased the latest developments in the pharmaceutical space across the globe and focused on ...
Read more: 13th CPhI and P-MEC India Expo showcased the glory of Indian pharmaceutical space

Pharma Reviews: 14th Biosimilars Congregation 2019

In addition, the networking opportunities in focused and relevant industry ... RISHI JAIN, Vice President, Medical, Clinical & Regulatory Affairs, India ...
Read more: 14th Biosimilars Congregation 2019

Pharma Reviews: Indian drugmakers aren't losing sleep despite getting a record 23 warnings from US FDA

The FDA has also increased its scrutiny of the Indian pharmaceutical sector. India accounted for nearly one-third of the total foreign inspections by ...
Read more: Indian drugmakers aren't losing sleep despite getting a record 23 warnings from US FDA

Pharma Reviews: Innovation top priority for Indian pharma, says Satish Reddy of Indian Pharmaceutical Alliance

Call it the BeiGene effect. Indian pharma and global multinational firms have been pointing out for almost a decade that China is taking a lead in ...
Read more: Innovation top priority for Indian pharma, says Satish Reddy of Indian Pharmaceutical Alliance

US FDA News: UPDATE: Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System - Letter to Health Care Providers

The FDA is providing the most recent, interim post-approval study results for Abiomed's Impella RP System.
Read more: UPDATE: Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System - Letter to Health Care Providers

Pharma Reviews: SCHOTT introduces new glass tank facility at Gujarat plant

The new set-up brings together SCHOTT's state-of-the-art technology and Indian ingenuity together to produce pharmaceutical packaging and tubing ...
Read more: SCHOTT introduces new glass tank facility at Gujarat plant

Pharma Reviews: German glass maker Schott to double India capacity, to invest 26 million euros targeting pharma ...

Schott, the German specialty glass maker is betting big on India, led by rising demand for pharmaceutical packaging material used in ampoules and ...
Read more: German glass maker Schott to double India capacity, to invest 26 million euros targeting pharma ...

Pharma Reviews: India boomed! How & why we lost the plot on the high growth path?

This mindshare within global business leaders helped the BPO industry and later the pharma industry walk on the footsteps of the IT industry with ...
Read more: India boomed! How & why we lost the plot on the high growth path?

Pharma Reviews: Big investment opportunities for Indian companies in various sectors available in Central American ...

Pharmaceutical sector: All three countries have a social security programme and spend a lot of money on procuring medicines. Indian generic ...
Read more: Big investment opportunities for Indian companies in various sectors available in Central American ...

Pharma Reviews: Pharma brings relief amid India's slowdown pain; here's how world sees Indian medicine market

While the Indian economy is facing a prolonged slowdown in almost all quarters, the pharma industry is giving some relief to the pain. India's pharma ...
Read more: Pharma brings relief amid India's slowdown pain; here's how world sees Indian medicine market

Pharma Reviews: Centaur Pharma's API Ambernath facility receives EIR from USFDA

Centaur Pharmaceuticals' state-of-the-art API Ambernath facility was ... Centaur Pharmaceuticals is a 100 million dollars Indian pharmaceutical ...
Read more: Centaur Pharma's API Ambernath facility receives EIR from USFDA

Pharma Reviews: Centaur Pharma Ambernath facility receives EIR from USFDA

Centaur Pharmaceuticals is a 100 million dollars Indian pharmaceutical company with exports to 110 countries. Centaur has a presence across the ...
Read more: Centaur Pharma Ambernath facility receives EIR from USFDA

Pharma Reviews: Centaur Pharma's API Ambernath facility receives EIR from USFDA

"This is a proud moment for Centaur, and a significant milestone for the Indian pharmaceutical industry," he added. Earlier in May 2019, Centaur ...
Read more: Centaur Pharma's API Ambernath facility receives EIR from USFDA

Pharma Reviews: CNBC-TV18 Market Live: Sensex rises 200 points, Nifty nears 12100; banks, auto stocks gain

Indian shares were trading higher on Wednesday with Nifty50 around .... Multinational pharma companies to sustain momentum in India, says CLSA.
Read more: CNBC-TV18 Market Live: Sensex rises 200 points, Nifty nears 12100; banks, auto stocks gain

Pharma Reviews: Will pharma regulator's deal with industry make non-price control drugs cheaper?

Non-scheduled drugs, or formulations outside price control, account for Rs 10,000 crore of sales in the Rs 1-lakh-crore Indian drug market, the report ...
Read more: Will pharma regulator's deal with industry make non-price control drugs cheaper?

Pharma Reviews: The Urge To Go Large

One in every three new drugs approved in the global market is a biotech drug. This, by itself, makes it an obvious space to be in, but for Indian ...
Read more: The Urge To Go Large

US FDA News: FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health

FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health
Read more: FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health

Pharma Reviews: India Health Exhibition Launches to Facilitate Growth in India's US$372 bn Healthcare Market

The medical device market is expected to reach US$ 11 billion by 2022. India has emerged as a hub for R&D activities for international players due to ...
Read more: India Health Exhibition Launches to Facilitate Growth in India's US$372 bn Healthcare Market

Pharma Reviews: Indian regulator flags products of three pharma PSUs for failing quality test

The Indian regulator has flagged Bengal Chemicals and Pharmaceuticals Ltd ... The regulator also pulled up the company's compound sodium lactate ...
Read more: Indian regulator flags products of three pharma PSUs for failing quality test

Pharma Reviews: Centaur Pharma's API Ambernath facility receives EIR from USFDA

"Centaur Pharma has been diligently complying with GMP regulations to ... Centaur Pharmaceuticals is a 100 million dollars Indian pharmaceutical ...
Read more: Centaur Pharma's API Ambernath facility receives EIR from USFDA

Pharma Reviews: Minister informs Parliament about steps taken to promote affordable generic drugs

31026/4/2018-Policy dated 01.01.2019 has notified Public Procurement (Preference to Make in India), Order, 2017, for Pharmaceutical Formulations.
Read more: Minister informs Parliament about steps taken to promote affordable generic drugs

Pharma Reviews: Pharma Inc agrees to cap margins on non-price control drugs at 30%

“The Indian Pharmaceutical Alliance, IDMA and the Organisation of Pharmaceutical Producers of India were supportive and willing to follow the cancer ...
Read more: Pharma Inc agrees to cap margins on non-price control drugs at 30%

Pharma Reviews: Stocks in Focus on November 27: Pharma Companies, HCL Tech, ICICI Bank; here are the 5 ...

Domestic Indian markets on Tuesday, November 26, 2019, hit new milestones but failed to hold on to gains and ended moderately lower. But certain ...
Read more: Stocks in Focus on November 27: Pharma Companies, HCL Tech, ICICI Bank; here are the 5 ...

Pharma Reviews: The 13th edition of CPhI & P-MEC India Expo leads the transformation in the global ...

The gathering represented the latest developments in the pharmaceutical ... With a 12% growth rate annually, the India Pharmaceutical market is ...
Read more: The 13th edition of CPhI & P-MEC India Expo leads the transformation in the global ...

US FDA News: California-based food manufacturer agrees to stop production after repeated food safety violations

California-based food manufacturer agrees to stop production after repeated food safety violations
Read more: California-based food manufacturer agrees to stop production after repeated food safety violations

US FDA News: B. Braun Medical Inc. Issues Voluntary Nationwide Recall of Twenty-Two (22) Lots of Blood Administration Sets, Due to Potential for Leakage at the Joint Between the Blood Filters and Tubing

B. Braun Medical Inc. [B. Braun] initiated a voluntary recall of twenty-two (22) lots of Blood Administration Sets. B. Braun identified through complaints and internal discrepancies the potential for leakage at the joint between the blood filters and tubing of these blood administration sets.
Read more: B. Braun Medical Inc. Issues Voluntary Nationwide Recall of Twenty-Two (22) Lots of Blood Administration Sets, Due to Potential for Leakage at the Joint Between the Blood Filters and Tubing

US FDA News: Statement by FDA Commissioner Scott Gottlieb, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on FDA’s continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk

FDA statement on stem cell enforcement actions and agency activities to facilitate legitimate product development
Read more: Statement by FDA Commissioner Scott Gottlieb, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on FDA’s continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk

Pharma Reviews: The 13th Edition of CPhI P-MEC India Expo Leads the Transformation in the Global ...

A new chapter of the widely appreciated India Pharma Week by Informa ... With a 12% growth rate annually, the India Pharmaceutical market is ...
Read more: The 13th Edition of CPhI P-MEC India Expo Leads the Transformation in the Global ...

Pharma Reviews: Film 'Ek MR ki Maut' released: Medical representatives are stressed, finds study

The study on the marketing practices of pharmaceutical companies along with ... and writer of the short film, 'Ek MR ki Maut', told The Indian Express that the film ... The study, 'Promotional Practices of the Pharmaceutical Industry and ...
Read more: Film 'Ek MR ki Maut' released: Medical representatives are stressed, finds study

Pharma Reviews: Raining USFDA warning letters to Indian drug sites point to intensified regulatory risk

However, it isn't a bad year for Aurobindo Pharma alone. The regulatory risk has intensified for the entire Indian pharmaceutical industry over the past ...
Read more: Raining USFDA warning letters to Indian drug sites point to intensified regulatory risk

Pharma Reviews: Price-fixing charges: Sun Pharma in talks with US to end anti-trust probe

In addition to Israel-based Teva, a unit of Indian generics giant Sun Pharmaceutical Industries Ltd. has also been in talks with federal prosecutors.
Read more: Price-fixing charges: Sun Pharma in talks with US to end anti-trust probe

US FDA News: FDA approves system for the delivery of ear tubes under local anesthesia to treat ear infection

FDA has approved a new system, the Tubes Under Local Anesthesia (Tula) System, for the delivery of tympanostomy tubes, commonly referred to as ear tubes, that can be inserted into the eardrum to treat recurrent ear infections.
Read more: FDA approves system for the delivery of ear tubes under local anesthesia to treat ear infection

US FDA News: FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns

FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns
Read more: FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns

US FDA News: FDA approves novel treatment to target abnormality in sickle cell disease

FDA granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease in adults and pediatric patients 12 years of age and older
Read more: FDA approves novel treatment to target abnormality in sickle cell disease

US FDA News: Statement on efforts to help make development of biosimilar and interchangeable insulin products more efficient

FDA issues guidance to help make development of biosimilar and interchangeable insulin products more efficient.
Read more: Statement on efforts to help make development of biosimilar and interchangeable insulin products more efficient

US FDA News: Statement on new steps to advance innovation in medical device sterilization with ethylene oxide

FDA is announcing the next steps in our ongoing efforts in medical device sterilization with ethylene oxide. This includes the selection results of our new Innovation Challenges, a recap and action items from our recent public advisory committee meeting, and the announcement of a new pilot program.
Read more: Statement on new steps to advance innovation in medical device sterilization with ethylene oxide

Pharma Reviews: Severe fragmentation responsible for poor performance of Indian healthcare: Yaduvendra Mathur ...

Sh. Yaduvendra Mathur noted that India's healthcare system lags much ... Captivating sessions attended by experts in healthcare, pharma industry, ...
Read more: Severe fragmentation responsible for poor performance of Indian healthcare: Yaduvendra Mathur ...

Pharma Reviews: India to grow strongly in 2020 as CPhI & P-MEC India opens

What's more, it also boasts the second-best score for 'competitiveness', and a separate report by IBEF has found that Indian pharma companies are ...
Read more: India to grow strongly in 2020 as CPhI & P-MEC India opens

Pharma Reviews: Develop entire value chain: Dr Reddy's MD tells pharma companies

Indian pharmaceutical companies need to undertake both backward and forward integration in the aftermath of US-China trade tensions, says G V ...
Read more: Develop entire value chain: Dr Reddy's MD tells pharma companies

Product Recall Alerts: Thousands MORE blood pressure pills are recalled

Thousands of blood pressure pills are recalled amid fears they could cause cancer ... July 5, 2018 – The UK recalled the drug over growing concerns. ... to not stop taking their medication, on the back of the new irbesartan alert.
Read more: Thousands MORE blood pressure pills are recalled

Pharma Reviews: The 13th edition of CPhI & P-MEC India Expo gears up to script the growth story of global Pharma ...

Apart from the business, and diverse events, key discussion areas will include 'Growth of Indian Pharmaceutical industry, identifying the strength of ...
Read more: The 13th edition of CPhI & P-MEC India Expo gears up to script the growth story of global Pharma ...

Pharma Reviews: Pharma pulse improves in Q2, but challenges remain heading into Q3

Mumbai: Indian pharmaceutical companies reported improved numbers for the second quarter, but much of the sector is not out of the woods yet.
Read more: Pharma pulse improves in Q2, but challenges remain heading into Q3

Product Recall Alerts: Four more manufacturers recall ranitidine products

The latest alert, revealed by PSNC, comes a day after Creo Pharma and Tillomed Laboratories recalled ranitidine ... Pharmacists are asked to stop supplying the recalled products immediately and remove from the store shelves.
Read more: Four more manufacturers recall ranitidine products

Pharma Reviews: Indian boards are meeting a tad more often

ET Intelligence Group: Indian boards are seem to be meeting slightly more ... For instance, pharma companies Cipla, Lupin and Sun Pharma have ...
Read more: Indian boards are meeting a tad more often

Pharma Reviews: Advent can deploy $1.7 bn in India in 3-5 years: Chairman

Additionally, we see an improvement in the exit market in terms of .... Indian pharma companies are battling both regulatory as well as pricing ...
Read more: Advent can deploy $1.7 bn in India in 3-5 years: Chairman

Pharma Reviews: Standardization- need of the hour for Traditional Medicines in India : Dr RB Smarta

Time has come when chemical products through pharma and herbal ... Ayurveda market in India is estimated at $ 2 billion, growing at double digits.
Read more: Standardization- need of the hour for Traditional Medicines in India : Dr RB Smarta

US FDA News: FDA approves new treatment for adults with partial-onset seizures

Today, the FDA approved a new treatment for adults with partial-onset seizures
Read more: FDA approves new treatment for adults with partial-onset seizures

Pharma Reviews: Big opportunity for the India pharma sector amidst US-China trade war: GV Prasad

He also added that Indian pharma companies also have a high potential to enhance their production and explore new areas within the pharma ...
Read more: Big opportunity for the India pharma sector amidst US-China trade war: GV Prasad

US FDA News: FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukemia

As part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, the FDA granted supplemental approval to Calquence (acalabrutinib) for the treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma
Read more: FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukemia

Product Recall Alerts: Creo Pharma, Tillomed Laboratories latest to recall ranitidine products

The Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday issued an alert to healthcare professionals, as Creo Pharma Limited ...
Read more: Creo Pharma, Tillomed Laboratories latest to recall ranitidine products

Product Recall Alerts: More prescription ranitidine recalled from shelves

The Medicines and Healthcare Regulatory Agency (MHRA) has issued a drug alert, as Creo Pharma Limited and Tillomed Laboratories have recalled ...
Read more: More prescription ranitidine recalled from shelves

Product Recall Alerts: Ranitidine Oral Solution and Tablets recall

Patients should not stop taking their medication, and a treatment review is ... On 8 October, 17 October and 25 October, MHRA drug alerts were also ...
Read more: Ranitidine Oral Solution and Tablets recall

Product Recall Alerts: Health Alerts: Car seats, baby powder, heartburn medicine and more recalled

Heartburn medicine recalled due to cancer concerns. Several companies have recalled heartburn drugs that contain ranitidine. The drugs might cause ...
Read more: Health Alerts: Car seats, baby powder, heartburn medicine and more recalled

US FDA News: FDA approves first treatment for inherited rare disease

: FDA grants approval to Givlaari (givosiran) for the treatment of adult patients with acute hepatic porphyria, a genetic disorder resulting in the buildup of toxic porphyrin molecules which are formed during the production of heme (which helps bind oxygen in the blood)
Read more: FDA approves first treatment for inherited rare disease

Pharma Reviews: TREND:MNCs may edge out domestic cos as Indian drug mkt set to zoom

MUMBAI – The $20 bln Indian pharmaceutical market is all set to nearly triple to $55 bln over the next decade, but domestic drug makers may not be ...
Read more: TREND:MNCs may edge out domestic cos as Indian drug mkt set to zoom

Pharma Reviews: Moscow Region Invites Indian Businesses To Invest

Deputy Governor of Moscow Region Vadim Khromov was in India to talk about ... Big Indian pharma companies including Dr Reddy's, Glenmark and ...
Read more: Moscow Region Invites Indian Businesses To Invest

Pharma Reviews: USFDA lens slow down Indian pharma exports, says CII official

All these are important things for the industry, he said when asked about the effect of frequent inspections of Indian pharma manufacturing plans by the ...
Read more: USFDA lens slow down Indian pharma exports, says CII official

US FDA News: Precision Dose Inc. Issues Voluntary Nationwide Recall of Ranitidine Oral Solution, USP 150 mg/10 mL Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity.

Precision Dose Inc. is voluntarily recalling 5 lots of Ranitidine Oral Solution, USP 150 mg/10 mL to the consumer level. Ranitidine Oral Solution, USP 150 mg/10 mL, is being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Read more: Precision Dose Inc. Issues Voluntary Nationwide Recall of Ranitidine Oral Solution, USP 150 mg/10 mL Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity.

US FDA News: Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps - Letter to Health Care Providers

The FDA is evaluating recent reports of Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices shutting down while running on battery power.
Read more: Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps - Letter to Health Care Providers

US FDA News: Update On Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps – Letter to Health Care Providers

The U.S. Food and Drug Administration (FDA) is providing an update on our evaluation of device failures associated with Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices: Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i.
Read more: Update On Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps – Letter to Health Care Providers

Pharma Reviews: Centaur Pharma's API Ambernath facility receives EIR from the USFDA

Centaur is India's largest, and the world's third largest manufacturer of ... Centaur Pharmaceuticals is a US$ 100 million Indian pharmaceutical ...
Read more: Centaur Pharma's API Ambernath facility receives EIR from the USFDA