Pharma Reviews: Warangal to host pharma science meet from Nov 1

Warangal Urban: Indian Association of Colleges of Pharmacy (IACP) will conduct a two-day 'National Pharmaceutical Sciences Congress -2019' on ...
Read more: Warangal to host pharma science meet from Nov 1

Pharma Reviews: A generous dose: why India should quickly start funding non-profit drug-discovery organisations

To ensure that its vast population has access to the best treatment, India ... With pharmaceutical giants not finding any business sense in developing ...
Read more: A generous dose: why India should quickly start funding non-profit drug-discovery organisations

Pharma Reviews: Pharma Science Congress from tomorrow in Hanamkonda

The Indian Association of Colleges of Pharmacy (IACP), a national organisation, is hosting a two-day National Pharmaceutical Sciences ...
Read more: Pharma Science Congress from tomorrow in Hanamkonda

US FDA News: ICU Medical, Inc. Issues a Voluntary Nationwide Recall of Lactated Ringer's Injection, USP and 0.9% Sodium Chloride Injection, USP Due to Presence of Particulate Matter

ICU Medical, Inc. (Nasdaq: ICUI) is voluntarily recalling one single lot of Lactated Ringer's Injection, USP, and one single lot of 0.9% Sodium Chloride Injection, USP. The products are being recalled to the hospital level due to the presence of particulate matter.
Read more: ICU Medical, Inc. Issues a Voluntary Nationwide Recall of Lactated Ringer's Injection, USP and 0.9% Sodium Chloride Injection, USP Due to Presence of Particulate Matter

US FDA News: USDA, EPA and FDA announce partnership with the Food Waste Reduction Alliance

New partnership with the Food Waste Reduction Alliance, the latest effort in the Winning on Reducing Food Waste Initiative launched by the three federal agencies in 2018.
Read more: USDA, EPA and FDA announce partnership with the Food Waste Reduction Alliance

Pharma Reviews: After Demonetisation, GST, Signing RCEP Will be Third 'Jolt' to Economy, Says Congress

"What is going to happen after the third jolt on Indian economy. ... Pharma industry would be the third biggest casualty and IPR issues would apply to ...
Read more: After Demonetisation, GST, Signing RCEP Will be Third 'Jolt' to Economy, Says Congress

US FDA News: Ethicon Recalls ECHELON FLEX™ ENDOPATH® Staplers for Failure to Completely Form Staples

Some ECHELON FLEX ENDOPATH staplers may contain an out of specification component, which may cause malformed staples, which may cause patient injury or death.
Read more: Ethicon Recalls ECHELON FLEX™ ENDOPATH® Staplers for Failure to Completely Form Staples

US FDA News: Digital submission of adverse event reports for investigational new drug applications reflects FDA’s ongoing modernization efforts

FDA is taking steps towards requiring electronic submission of certain safety reports under an investigational new drug (IND) application into the FDA's Adverse Event Reporting System (FAERS).
Read more: Digital submission of adverse event reports for investigational new drug applications reflects FDA’s ongoing modernization efforts

US FDA News: Lannett Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/ml due to an Elevated Level of the Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

Lannett Company, Inc. today announced that it is voluntarily recalling all lots within expiry of Ranitidine Syrup
Read more: Lannett Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/ml due to an Elevated Level of the Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

US FDA News: FDA issues policy to facilitate the use of electronic health record data in clinical investigations

FDA issues policy to facilitate the use of electronic health record data in clinical investigations
Read more: FDA issues policy to facilitate the use of electronic health record data in clinical investigations

US FDA News: Statement on FDA’s new report regarding root causes and potential solutions to drug shortages

Today, the FDA is issuing a report on causes and solutions to drug shortages
Read more: Statement on FDA’s new report regarding root causes and potential solutions to drug shortages

US FDA News: Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication

The FDA is evaluating new information about the risk of blood continuing to leak into the aneurysm (Type III endoleak) with Endologix AFX.
Read more: Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems: FDA Safety Communication

Pharma Reviews: Gujarat is FAST regaining its lost share in pharma

So how has GST been a change-maker for the pharma industry? ... The exodus back then had brought Gujarat's share in India's pharma production ...
Read more: Gujarat is FAST regaining its lost share in pharma

US FDA News: Mylan Pharmaceuticals Initiates Voluntary Nationwide Recall of One Lot of Alprazolam Tablets, USP C-IV 0.5 mg, Due to the Potential of Foreign Substance

Mylan Pharmaceuticals Inc. is conducting a voluntary nationwide recall of one lot (see table below) of Alprazolam Tablets, USP C-IV 0.5 mg, to the consumer/user level. This lot is being recalled due to the potential presence of foreign substance
Read more: Mylan Pharmaceuticals Initiates Voluntary Nationwide Recall of One Lot of Alprazolam Tablets, USP C-IV 0.5 mg, Due to the Potential of Foreign Substance

Product Recall Alerts: Novitium Pharma Issues Voluntary National Recall of Ranitidine Hydrochloride Capsules 150mg ...

Novitium Pharma Issues Voluntary National Recall of Ranitidine ... When a company announces a recall, market withdrawal, or safety alert, the FDA posts ... Ranitidine Hydrochloride Capsules are being recalled because of potential ...
Read more: Novitium Pharma Issues Voluntary National Recall of Ranitidine Hydrochloride Capsules 150mg ...

Product Recall Alerts: Popular heartburn medications urgently recalled over cancer fears

Popular brands of heartburn medication - including Zantac - have been recalled ... products Regulatory Agency (MHRA), which has sent out an alert.
Read more: Popular heartburn medications urgently recalled over cancer fears

US FDA News: Novitium Pharma Issues Voluntary National Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

Voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules in the US to the consumer level. Ranitidine Hydrochloride Capsules are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Read more: Novitium Pharma Issues Voluntary National Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

US FDA News: FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease

FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease
Read more: FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease

US FDA News: Statement on concerns with medical device availability due to certain sterilization facility closures

In light of the possibility of continued ethylene oxide sterilization facility closures, FDA is again alerting the public to growing concerns about the future availability of sterile medical devices and impending medical device shortages.
Read more: Statement on concerns with medical device availability due to certain sterilization facility closures

Pharma Reviews: Cipla may raise bar with digital therapeutics push

The new role of a pharma company is being envisioned as one ... Most Indian pharma companies are now tweaking their business models, strategies, ...
Read more: Cipla may raise bar with digital therapeutics push

Pharma Reviews: Guidelines released for evaluation of nano drugs

... bio-industry, bio-energy, bio-services and bio-pharma sectors. ... General of India, VG Somani, hoped that the Indian pharmaceutical sector would ...
Read more: Guidelines released for evaluation of nano drugs

US FDA News: Statement on agency’s first year accomplishments implementing SUPPORT Act authorities to address the opioids crisis

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on agency’s first year accomplishments implementing SUPPORT Act authorities to address the opioids crisis
Read more: Statement on agency’s first year accomplishments implementing SUPPORT Act authorities to address the opioids crisis

US FDA News: Statement on the agency’s efforts to protect patients from potentially harmful drugs sold as homeopathic products

Today, the FDA is taking two new steps toward clarifying the agency’s approach on homeopathic products.
Read more: Statement on the agency’s efforts to protect patients from potentially harmful drugs sold as homeopathic products

Pharma Reviews: 5th Grand edition of “Nutrition & Wellness 2019” Conference & Awards

Participating & Invited companies include GSK, Dabur, Nestle India, Abbott ... Medical foods (foods with distinctive nutritional value that are specially ...
Read more: 5th Grand edition of “Nutrition & Wellness 2019” Conference & Awards

Pharma Reviews: Eminence Business Media's 2nd Annual Pharma Manufacturing & Automation Convention 2019 ...

Eminence Business Media's 2nd Annual Pharma Manufacturing & Automation ... session which included a group discussion on Indian Pharma Today:.
Read more: Eminence Business Media's 2nd Annual Pharma Manufacturing & Automation Convention 2019 ...

Product Recall Alerts: Dr Reddy's recalls ranitidine tablets from US retail counters

Dr Reddy's had initiated a voluntary recall of the medicine at the retail level for over-the-counter products and at the consumer level for prescription products on 1 October after the US FDA had issued a caution note alerting patients ...
Read more: Dr Reddy's recalls ranitidine tablets from US retail counters

US FDA News: Perrigo Company plc Issues Voluntary Worldwide Recall of Ranitidine Due to Possible Presence of Impurity, N-nitrosodimethylamine (NDMA) Impurity in the Product

As a precautionary measure, Perrigo Company plc announced today that it has initiated a voluntary, worldwide product recall to the retail customer level of ranitidine (all pack sizes). The recall is being taken due to possible presence of a nitrosamine impurity called N-nitrosodimethylamine (NDMA).
Read more: Perrigo Company plc Issues Voluntary Worldwide Recall of Ranitidine Due to Possible Presence of Impurity, N-nitrosodimethylamine (NDMA) Impurity in the Product

US FDA News: Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S.

As a precautionary measure, Sanofi on Friday, October 18, intiated a voluntary recall of all Zantac OTC (over-the-counter) in the United States. This includes Zantac 150®, Zantac 150® Cool Mint, and Zantac 75®.
Read more: Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S.

US FDA News: Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine Products in the U.S. Market

Nationwide recall on October 1, 2019, (at the retail level for over-the-counter products and at the consumer level for prescription products) of all of its ranitidine medications sold in US due to confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA
Read more: Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine Products in the U.S. Market

Pharma Reviews: Schott Kaisha to open first unit in Himachal Pradesh

In an endeavour to make India a global leader in the pharma sphere and Himachal Pradesh the country's next “Industrial Hub”, SCHOTT KAISHA, the ...
Read more: Schott Kaisha to open first unit in Himachal Pradesh

US FDA News: Statement on the agency’s continued efforts to protect women’s health and enhance safety information available to patients considering breast implants

FDA statement on the agency’s continued efforts to protect women’s health and enhance safety information available to patients considering breast implants
Read more: Statement on the agency’s continued efforts to protect women’s health and enhance safety information available to patients considering breast implants

Pharma Reviews: Marg ERP's CMD Mr. Thakur Anup Singh Wins Prestigious Udyog Rattan Award

Marg ERP leader in inventory and accounting software in India. - Leader in providing software solutions to Pharma & FMCG sectors. - Currently, 2 ...
Read more: Marg ERP's CMD Mr. Thakur Anup Singh Wins Prestigious Udyog Rattan Award

US FDA News: GL Holdings Issues Voluntary Worldwide Recall of Green Lumber Products Due to Presence of Undeclared Tadalafil

GL Holdings is voluntarily recalling six lots of Green Lumber 2-, 4-, and 10-capsule packages purchased on or before August 10, 2019 to the consumer level. FDA analysis has found one lot of Green Lumber distributed between June and August 2019 to be tainted with tadalafil.
Read more: GL Holdings Issues Voluntary Worldwide Recall of Green Lumber Products Due to Presence of Undeclared Tadalafil

Pharma Reviews: Marg ERP's CMD Mr. Thakur Anup Singh Wins Prestigious Udyog Rattan Award

(Eds: Disclaimer: The following press release comes to you under an arrangement with PR Newswire. PTI takes no editorial responsibility for the same ...
Read more: Marg ERP's CMD Mr. Thakur Anup Singh Wins Prestigious Udyog Rattan Award

US FDA News: FDA grants first-ever modified risk orders to eight smokeless tobacco products

The FDA announced today that, for the first time, it has authorized the marketing of products through the modified risk tobacco product (MRTP) pathway. The authorizations are for eight Swedish Match USA, Inc. snus smokeless tobacco products sold under the “General” brand name.
Read more: FDA grants first-ever modified risk orders to eight smokeless tobacco products

US FDA News: FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease

The U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter to Rooted Apothecary LLC for illegally selling unapproved products containing cannabidiol with unsubstantiated claims.
Read more: FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease

Pharma Reviews: Commerce and Industry Minister Piyush Goyal on a Two-Day Visit to Sweden

There are over 70 Indian companies including IT companies currently present in Sweden. Indian pharma and biotech companies like Dr.Reddys, ...
Read more: Commerce and Industry Minister Piyush Goyal on a Two-Day Visit to Sweden

Pharma Reviews: Telangana seeks Rs 3418 cr for Hyderabad Pharma City

Industries Minister K.T. Rama Rao has written to Union Commerce ... KTR also wrote that the Hyderabad Pharma City promises to position India as the ...
Read more: Telangana seeks Rs 3418 cr for Hyderabad Pharma City

Product Recall Alerts: Five things for pharma marketers to know: Monday, October 21, 2019

J&J is recalling 33,000 bottles of baby powder in the U.S. The company is ... the FDA issued an alert about a cancer-causing chemical found in the medicine. ... Takeda recalled the drug, Natpara, last month after learning that rubber ...
Read more: Five things for pharma marketers to know: Monday, October 21, 2019

Pharma Reviews: Top US drug companies reach $260 million deal to settle opioids lawsuit

The settlement means the trial will not move forward, but it does not resolve more than 2,600 other lawsuits across the US seeking to hold the drug ...
Read more: Top US drug companies reach $260 million deal to settle opioids lawsuit

Pharma Reviews: KTR seeks Rs 3400 crore from Central government for Hyderabad Pharma City

HYDERABAD: Industries Minister KT Rama Rao on Sunday dashed off ... for the industry sector in the country in carrying forward the Make in India ...
Read more: KTR seeks Rs 3400 crore from Central government for Hyderabad Pharma City

US FDA News: FDA approves new breakthrough therapy for cystic fibrosis

FDA approves breakthrough therapy Trikafta for patients 12 and older with cystic fibrosis who have at least one F508del mutation in the CFTR gene, estimated to represent 90% of the cystic fibrosis population.
Read more: FDA approves new breakthrough therapy for cystic fibrosis

Pharma Reviews: Piyush Goyal to attend 19th Session of Indo-Swedish Joint Commission

Commerce and Industry & Railways Minister, Piyush Goyal will attend the ... Indian pharma and biotech companies like Dr.Reddys, Biocon, Kemwell ...
Read more: Piyush Goyal to attend 19th Session of Indo-Swedish Joint Commission

Pharma Reviews: Govt urges pharma cos to be vigilant about pollution at manufacturing plants

In a letter written on 11 October, the department asked Indian Drug Manufacturers' Association (IDMA), Organization of Pharmaceutical Producers of ...
Read more: Govt urges pharma cos to be vigilant about pollution at manufacturing plants

Pharma Reviews: Japan has huge export potential in pharma, gems and jewellery sectors: FIEO

“In many of the products, the share of India is extremely low. India's share in electric and electronic components, machinery pharmaceutical and ...
Read more: Japan has huge export potential in pharma, gems and jewellery sectors: FIEO

Pharma Reviews: Telangana Minister KT Rama Rao seeks central assistance for Hyderabad pharma city

HYDERABAD: Telangana IT and Industries Minister KT Rama Rao on ... India as the global manufacturing hub for pharmaceuticals, KTR said, For a ...
Read more: Telangana Minister KT Rama Rao seeks central assistance for Hyderabad pharma city

Pharma Reviews: How a Chinese movie became talking point as PM Modi met top Bollywood stars

India has been calling China to allow greater market access for Indian pharma products which can help narrow the $55 billion trade deficit. Several ...
Read more: How a Chinese movie became talking point as PM Modi met top Bollywood stars

Pharma Reviews: How a Chinese movie became talking point as PM Modi met top film stars to discuss Mahatma ...

China imports around US $25 billion worth of Pharma products of which a ... India has been calling China to allow greater market access for Indian ...
Read more: How a Chinese movie became talking point as PM Modi met top film stars to discuss Mahatma ...

Pharma Reviews: E-Pharmacies to Grow to $3.7 Billion by 2022: CLSA

The Indian pharma market is valued at $20 billion and has been growing at 10-12 per cent. Continuation of current growth trends could propel the ...
Read more: E-Pharmacies to Grow to $3.7 Billion by 2022: CLSA

Pharma Reviews: Top 5 Websites Offering Health and Wellness Solutions

This is another major medicine delivery portal that is making its presence felt in the Indian e-pharmacy market. They have a very user-friendly UI that ...
Read more: Top 5 Websites Offering Health and Wellness Solutions

Product Recall Alerts: Johnson & Johnson recalls one lot of baby powder after trace amounts of asbestos found

The move marks the first time the company has recalled its baby powder for ... The voluntary recall is limited to one lot of Johnson's Baby Powder ... from the FDA on Thursday alerting the company about the asbestos finding. ... that the medicine may be tainted with a compound that could cause cancer.
Read more: Johnson & Johnson recalls one lot of baby powder after trace amounts of asbestos found

Product Recall Alerts: Teva recalls tainted Zantac generics in the UK

Teva, which does not sell ranitidine products in the U.S., has recalled 10 ... and recalled their Zantac generics when the alert was first raised by the FDA. ... impurity in the drug, prompting more drugmakers to initiate voluntary recalls.
Read more: Teva recalls tainted Zantac generics in the UK

Pharma Reviews: Govt plans to treat medical implants as medicine

Govt plans to treat medical implants as medicine ... a series of investigative reports highlighting lapses in regulation in India's medical devices industry ...
Read more: Govt plans to treat medical implants as medicine

Pharma Reviews: Centrient Pharma files second lawsuit against Dalas Biotech

Centrient, which has manufacturing sites and sales offices in China, India, Egypt, the Netherlands, Spain, the US and Mexico, had filed the first lawsuit ...
Read more: Centrient Pharma files second lawsuit against Dalas Biotech

Pharma Reviews: MP Investor Summit: Reliance, ITC, Sun Pharma announce investment plans

During the one-day event, Magnificent Madhya Pradesh (MMP), Reliance Industries and ITC announced their investment plans for the central Indian ...
Read more: MP Investor Summit: Reliance, ITC, Sun Pharma announce investment plans

US FDA News: Baby powder manufacturer voluntarily recalls products for asbestos

The FDA is alerting consumers of a voluntary recall by Johnson & Johnson of Johnson’s Baby Powder after FDA testing has found that a sample from one lot of the product contains chrysotile fibers, a type of asbestos.
Read more: Baby powder manufacturer voluntarily recalls products for asbestos

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety

Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety

Pharma Reviews: Online pharmacies to grow to $3.7 billion by 2022: CLSA

The Indian pharma market is valued at $20 billion and has been growing at ... As per Frost and Sullivan, e-pharmacy is a nascent market worth $0.5 ...
Read more: Online pharmacies to grow to $3.7 billion by 2022: CLSA

Pharma Reviews: Indore: Top Indian business magnets, bureaucrats in city today

Indore: Top Indian business magnets, bureaucrats in city today ... witness a congregation of top business magnets of the Indian industry on Friday, ... Aadi Godrej, Rajinder Gupta of Trident Group and Dilip Sanghvi of Sun Pharma.
Read more: Indore: Top Indian business magnets, bureaucrats in city today

US FDA News: Viatrexx Bio Incorporated Issues Voluntary Nationwide Recall of Sterile Injectables due to a Lack of Sterility Assurance

Viatrexx Bio Incorporated, Newark, Delaware is voluntarily recalling 10 mL sterile injectable vials of products, listed in the table below with lot numbers, to the consumer level. The products were sold exclusively to practitioners for office use. The products were manufactured in a manner that cann
Read more: Viatrexx Bio Incorporated Issues Voluntary Nationwide Recall of Sterile Injectables due to a Lack of Sterility Assurance

US FDA News: Statement on continued progress enhancing patient access to high-quality, low-cost generic drugs

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on continued progress enhancing patient access to high-quality, low-cost generic drugs
Read more: Statement on continued progress enhancing patient access to high-quality, low-cost generic drugs

US FDA News: 2019 Biologics Recalls

2019 Biologics Recalls<div class="table-responsive">
<table class="table table-bordered" summary="2019 Biologics Recalls">
<thead>
<tr>
<th scope="col">Date Notification
</th>
<th scope="col">Brand Name
</th>
<th scope="col">Product Description

Read more: 2019 Biologics Recalls

US FDA News: Important Drug Information - Humate-P [Antihemophilic Factor/von Willebrand Factor Complex (Human)]

CSL Behring LLC is alerting customers to a misalignment in the printing of the data on the folding box of Humate-P that might lead to confusion of the user.
Read more: Important Drug Information - Humate-P [Antihemophilic Factor/von Willebrand Factor Complex (Human)]

Pharma Reviews: ePharmacy Market to Witness Steady Growth Based on Rising Pharmaceutical Products Sale ...

This is attributed to the upsurge in pharmaceutical products' sale through ... upon e-Pharma as a promising investment in India as well as globally.
Read more: ePharmacy Market to Witness Steady Growth Based on Rising Pharmaceutical Products Sale ...

Pharma Reviews: Avery Dennison's push at making a material difference for the label converters and brands

We are fulfilling the new legislation in Europe called European Falsified Medicines Directive (FMD). The Indian market exports to Europe in a big way.
Read more: Avery Dennison's push at making a material difference for the label converters and brands

Pharma Reviews: Drug regulator steps up monitoring of ranitidine

In India, a host of companies including GlaxoSmithKline, JB Chemicals, Cadila Pharma, Zydus Cadila, Dr Reddy's and Sun Pharmaceuticals sell over ...
Read more: Drug regulator steps up monitoring of ranitidine

Pharma Reviews: Market access hurdles restricting exports to China: FIEO

Dairy products, bovine meat, soyabean meal and many fruits are not given market access which is equally a problem for Indian pharma industry as ...
Read more: Market access hurdles restricting exports to China: FIEO

Pharma Reviews: At Modi-Xi Informal Summit, India and China Announce New Dialogue Mechanism on Trade

President Xi also briefed India about Pakistan Prime Minister Imran Khan's recent ... Xi also invited Indian pharma and IT companies to invest in China.
Read more: At Modi-Xi Informal Summit, India and China Announce New Dialogue Mechanism on Trade

Pharma Reviews: Indore: Top industry honchos to address Magnificent MP meet

The prominent speakers are NITI Aayog CEO Amitabh Kant, Aditya Birla Group chairman Kumarmangalam Birla, Sun Pharma MD Dilip Sanghvi, India ...
Read more: Indore: Top industry honchos to address Magnificent MP meet

Pharma Reviews: Malvinder Singh: From Pharaoh of Pharma to being in custody

Malvinder Singh: From Pharaoh of Pharma to being in custody ... made him seem well suited to a competitive industry with a social mission at its core. ... The fawning Indian business press dubbed him “the Pharaoh of Pharma” and ...
Read more: Malvinder Singh: From Pharaoh of Pharma to being in custody

Pharma Reviews: Chennai summit pragmatic way of constructive engagement to resolve trade, other issues, says ...

... soyabean meal and many fruits are not given market access which is equally a problem for Indian pharma industry as registration takes enormous ...
Read more: Chennai summit pragmatic way of constructive engagement to resolve trade, other issues, says ...

Pharma Reviews: Jefferies: Vaccine, dental, urology drive pharma growth

Indian pharma market growth accelerated in September to 11.9% vs 9.5% in August. The second quarter growth stood at 11%, the highest quarterly ...
Read more: Jefferies: Vaccine, dental, urology drive pharma growth

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

The U.S. Food and Drug Administration today approved Reyvow (lasmiditan) tablets for the acute (active but short-term) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. Reyvow is not indicated for the preventive treatment of migraine.
Read more: FDA approves new treatment for patients with migraine

Pharma Reviews: Need to pull up Aurobindo Pharma over disclosures

The domestic pharmaceutical industry is not known for its promptness in following disclosure norms of the Securities and Exchange Board of India.
Read more: Need to pull up Aurobindo Pharma over disclosures

US FDA News: Lung Injury Update: FDA Warns Public to Stop Using Tetrahydrocannabinol (THC)-Containing Vaping Products and Any Vaping Products Obtained Off the Street

FDA is strengthening its warning to consumers to stop using vaping products containing THC amid more than 1,000 reports of lung injuries—including some resulting in deaths—following the use of vaping products.
Read more: Lung Injury Update: FDA Warns Public to Stop Using Tetrahydrocannabinol (THC)-Containing Vaping Products and Any Vaping Products Obtained Off the Street

Pharma Reviews: Export opportunity for domestic pharmaceuticals | Ravi Uday Bhaskar to ET Now

With India's pharmaceutical exports at $19 billion in 2019, where do the new opportunities lie? How will India deal with the regulatory overhang?
Read more: Export opportunity for domestic pharmaceuticals | Ravi Uday Bhaskar to ET Now

US FDA News: Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of all Sterile Compounded Drug Products Due to a Lack of Sterility Assurance

Innoveix Pharmaceuticals, Inc. is voluntarily recalling all sterile compounded drug products, within expiry, to the consumer level. The products are being recalled due to a lack of assurance of sterility. These concerns arose following a routine inspection of the pharmacy by FDA.
Read more: Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of all Sterile Compounded Drug Products Due to a Lack of Sterility Assurance

Pharma Reviews: Satish Reddy appointed Indian Pharmaceutical Alliance president

HYDERABAD, Oct 10:Satish Reddy, Chairman of Dr. Reddy's Laboratories Limited has been appointed President of the Indian Pharmaceutical ...
Read more: Satish Reddy appointed Indian Pharmaceutical Alliance president

US FDA News: FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens

Today, FDA allowed marketing of a rapid diagnostic test (RDT) to detect Ebola virus antigens. The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test FDA has allowed to be marketed in the U.S. for Ebola Virus Disease (EVD).
Read more: FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens

Pharma Reviews: Dr Reddys Chairman Satish Reddy named as New President of Indian Pharmaceutical Alliance

Dr Reddy's Labs' Chairman, Satish Reddy played a key role in shaping policies concerning the pharmaceutical sector as well as the economy, such ...
Read more: Dr Reddys Chairman Satish Reddy named as New President of Indian Pharmaceutical Alliance

Pharma Reviews: Satish Reddy appointed as IPA president

Hyderabad: Satish Reddy, chairman of Dr Reddy's has been appointed as president of the Indian Pharmaceutical Alliance (IPA) for 2019-2021.
Read more: Satish Reddy appointed as IPA president

Pharma Reviews: Satish Reddy appointed Indian Pharmaceutical Alliance

Satish Reddy appointed Indian Pharmaceutical Alliance president Hyderabad, Oct 10 (PTI): Satish Reddy, Chairman of Dr. Reddy's Laboratories ...
Read more: Satish Reddy appointed Indian Pharmaceutical Alliance

Pharma Reviews: Satish Reddy appointed as Indian Pharmaceutical Alliance president

"The leadership at IPA will help in unleashing the potential of the Indian pharma industry and strengthen the innovation ecosystem further growth for ...
Read more: Satish Reddy appointed as Indian Pharmaceutical Alliance president

Pharma Reviews: Chinese growth shot's some years away for pharma companies

For most other Indian pharmaceutical companies venturing into China, the market is restricted to the licensing of speciality products, with monetisation ...
Read more: Chinese growth shot's some years away for pharma companies

Pharma Reviews: Higher regulatory risk to affect drug cos' earnings

Indian generic pharmaceutical companies that export drugs to the US, therefore, find themselves in the throes of another regulatory crisis merely four ...
Read more: Higher regulatory risk to affect drug cos' earnings

Product Recall Alerts: GSK joins other drugmakers recalling Zantac products

GSK joins other drugmakers recalling Zantac products ... developer of heartburn medicine Zantac, is recalling the ranitidine medicines globally. ... Reddy's Laboratories, went ahead and recalled their Zantac generics when the alert ...
Read more: GSK joins other drugmakers recalling Zantac products

Pharma Reviews: India's Pharma Market Grows At Fastest Pace In At Least Five Quarters

India's pharmaceutical market grew at its fastest pace in more than a year in the quarter ended September on higher volumes and prices even as new ...
Read more: India's Pharma Market Grows At Fastest Pace In At Least Five Quarters

Pharma Reviews: India: Establishing A Business In India

The applicant or the parent/ group company is also required to satisfy certain ... Non-resident companies may establish a project office in India, provided: (i) ... Investment above 74% and up to 100% is permitted in brownfield pharma.
Read more: India: Establishing A Business In India

US FDA News: ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of Plum and Sapphire Microbore Infusion Sets with Inline Filters

ICU Medical, Inc. announced a voluntary recall on 29 July 2019 of certain lots of Plum and Sapphire Microbore Infusion Sets with inline filters due to the potential for small amounts of fluid leaking out of the air vents on the inline filters. To date, ICU Medical is not aware of adverse events rela
Read more: ICU Medical Issues a Voluntary Nationwide Recall of Certain Lots of Plum and Sapphire Microbore Infusion Sets with Inline Filters

US FDA News: Medtronic Recalls 6 French Sherpa NX Active Guide Catheters Due to Separation and Fragmentation Issue

Medtronic is recalling the 6 French Sherpa NX Active Guide Catheter due to a risk of the outer material separating from the device resulting in detached fragments that could result in the underlying stainless-steel braid wires being exposed.
Read more: Medtronic Recalls 6 French Sherpa NX Active Guide Catheters Due to Separation and Fragmentation Issue

US FDA News: FDA approves first treatment to increase pain-free light exposure in patients with a rare disorder

FDA approves first treatment to increase pain-free light exposure in patients with a rare disorder
Read more: FDA approves first treatment to increase pain-free light exposure in patients with a rare disorder

US FDA News: FDA awards two grants for natural history studies in rare diseases

FDA awards two grants for natural history studies in rare diseases
Read more: FDA awards two grants for natural history studies in rare diseases

US FDA News: Global Commodities Corporation Recalls Buenas Grated Coconut Due to Possible Health Risk-Medical devices

Global Commodities Corporation, Hayward, CA is recalling one lot of Buenas Brand frozen grated coconut because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with we
Read more: Global Commodities Corporation Recalls Buenas Grated Coconut Due to Possible Health Risk-Medical devices

US FDA News: FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases
Read more: FDA awards 12 grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases

Pharma Reviews: Regulatory interventions constraining Profitability of Indian pharma: ICRA

New Delhi: The growth and profitability of Indian pharmaceutical companies in the current financial year will be constrained by regulatory interventions ...
Read more: Regulatory interventions constraining Profitability of Indian pharma: ICRA

Pharma Reviews: Pharma cos need to quickly learn how to balance interests of investors and patients

For Indian pharma companies, supplying low-cost drugs globally, balancing the interests of shareholders with those of patients was not so difficult till ...
Read more: Pharma cos need to quickly learn how to balance interests of investors and patients

Pharma Reviews: FDA observations on Telangana plant a fresh headache for Aurobindo Pharma

Indian pharma companies with exposure to the US market have been impacted due to pricing pressure on account of channel consolidation and ...
Read more: FDA observations on Telangana plant a fresh headache for Aurobindo Pharma

US FDA News: CBER FY 2019 Recall Postings

Listing of CBER FY 2019 Recall Postings
Read more: CBER FY 2019 Recall Postings

US FDA News: CBER FY 2018 Recall Postings

List of CBER FY 2018 Recall Postings.
Read more: CBER FY 2018 Recall Postings

US FDA News: 2019 Safety Communications

The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management.
Read more: 2019 Safety Communications

US FDA News: URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices: FDA Safety Communication

URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices: FDA Safety Communication
Read more: URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices: FDA Safety Communication

Pharma Reviews: Mylan to invest $6 billion on capex in India to incentivise R&D activities

Multinational drug company Mylan is all set to invest on capex in India. It has said it will invest $1 billion in the next 5-6 years on it, considering the ...
Read more: Mylan to invest $6 billion on capex in India to incentivise R&D activities

Pharma Reviews: Stocks to watch: TCS, Yes Bank, Zee Entertainment, pharma companies, BPCL

This is likely to set the tone and steer the Indian equity market this week. ... Glenmark Pharma: The US Food and Drug Administration has issued a ...
Read more: Stocks to watch: TCS, Yes Bank, Zee Entertainment, pharma companies, BPCL

Pharma Reviews: Tax cuts to jazz up Q2 bottomlines of Nifty50 even as revenue growth slows

Management outlook on performance of specialty drugs portfolio, volume growth in Indian pharma market and update on regulatory compliance will ...
Read more: Tax cuts to jazz up Q2 bottomlines of Nifty50 even as revenue growth slows

Pharma Reviews: The poor must be given priority

Efforts by giant US and European pharmaceutical companies to remove competition from India and its generic drugs industry need to be countered.
Read more: The poor must be given priority

Pharma Reviews: Pending patents key to bridge vast tech gap with US, China

India's patent law also prevents evergreening, which refers to attempts by pharma companies to tweak their patented product or process to seek new ...
Read more: Pending patents key to bridge vast tech gap with US, China

Pharma Reviews: Margin pressure to persist for pharma companies: ICRA

New Delhi: The growth and profitability of Indian pharmaceutical companies in current financial year will be constrained by regulatory interventions ...
Read more: Margin pressure to persist for pharma companies: ICRA

Pharma Reviews: Margin pressure to persist for pharma companies: ICRA

NEW DELHI: The growth and profitability of Indian pharmaceutical companies in a current financial year will be constrained by regulatory interventions ...
Read more: Margin pressure to persist for pharma companies: ICRA

Pharma Reviews: Margin pressure to persist for pharma companies: ICRA

New Delhi [India], Oct 5 (ANI): The growth and profitability of Indian pharmaceutical companies in current financial year will be constrained by ...
Read more: Margin pressure to persist for pharma companies: ICRA

US FDA News: Lung Injury Update: FDA Warns Public to Stop Using Tetrahydrocannabinol (THC)-Containing Vaping Products and Any Vaping Products Obtained Off the Street

FDA is strengthening its warning to consumers to stop using vaping products containing THC amid more than 1,000 reports of lung injuries—including some resulting in deaths—following the use of vaping products.
Read more: Lung Injury Update: FDA Warns Public to Stop Using Tetrahydrocannabinol (THC)-Containing Vaping Products and Any Vaping Products Obtained Off the Street

US FDA News: Statement on consumer warning to stop using THC vaping products amid ongoing investigation into lung illnesses

Statement from Acting FDA Commissioner Ned Sharpless, M.D., on consumer warning to stop using THC vaping products amid ongoing investigation into lung illnesses
Read more: Statement on consumer warning to stop using THC vaping products amid ongoing investigation into lung illnesses

Product Recall Alerts: Recalled by GSK, acidity drug accused of causing cancer still sells in India. Blame varying test ...

While GSK and Dr. Reddy's have recalled the drug globally, Cadila Pharma and JB Chemicals say they will continue to sell it as their internal tests ...
Read more: Recalled by GSK, acidity drug accused of causing cancer still sells in India. Blame varying test ...

Pharma Reviews: Implementing GLN for hospitals needs a mind set change: Ravi Mathur, CEO, GS1 India

Ravi Mathur, CEO, GS1 India speaks to Viveka Roychowdhury on the ... More than 380 large and medium sized pharma companies currently upload ...
Read more: Implementing GLN for hospitals needs a mind set change: Ravi Mathur, CEO, GS1 India

US FDA News: FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic

FDA approved Descovy in at-risk adults and adolescents for HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex.
Read more: FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic

Pharma Reviews: View: India Inc now needs to follow up on opportunities created by the govt

Many of Indian pharma companies followed this approach and now gain the bulk of their revenues from the US and other advanced economies.
Read more: View: India Inc now needs to follow up on opportunities created by the govt

Pharma Reviews: Price cap on US stents may stay to keep healthcare affordable. But can India fill the research gap?

Market watchers believe that India may give into the demand for better access by US medical devices manufacturers to boost trade and reduce ...
Read more: Price cap on US stents may stay to keep healthcare affordable. But can India fill the research gap?

Pharma Reviews: Lupin appoints Apotex veteran as new head of quality

Pharmaceuticals maker Lupin has appointed a new head of quality for the company, as it strives to remain compliant with international safety and ...
Read more: Lupin appoints Apotex veteran as new head of quality

Pharma Reviews: Have the Building Blocks Been Put in Place for an Indo-US Pact on Bilateral Trade?

For India, it is vital to expand its exports into the US to help our own .... Visits US, What Does the Free Trade Pact Mean for India's Pharma Industry?
Read more: Have the Building Blocks Been Put in Place for an Indo-US Pact on Bilateral Trade?

Pharma Reviews: Indian Travel & Tourism: Surging job opportunities

India's travel and tourism sector are poised to clock rapid strides of growth and ... The tourism sector remains extremely dependent on human resources. ... focused on providing innovator pharma companies with drug discovery, ...
Read more: Indian Travel & Tourism: Surging job opportunities

Product Recall Alerts: Ranitidine ban: Indian drug regulator 'alerts' state authorities to ensure patient safety

The Italian Drug Agency has also recalled ranitidine-based drug brands, including those made with active ingredient from an Indian company named ...
Read more: Ranitidine ban: Indian drug regulator 'alerts' state authorities to ensure patient safety

US FDA News: FDA informs patients, providers and manufacturers about potential cybersecurity vulnerabilities for connected medical devices and health care networks that use certain communication software

FDA is informing patients, health care professionals, IT staff in health care facilities and manufacturers of a set of cybersecurity vulnerabilities, referred to as “URGENT/11,” that—if exploited by a remote attacker—may introduce risks for medical devices and hospital networks
Read more: FDA informs patients, providers and manufacturers about potential cybersecurity vulnerabilities for connected medical devices and health care networks that use certain communication software

Pharma Reviews: Indian science and research establishments need a commercial focus: Binod Singh

This includes 4.5% in medical technology, 2.1% in biotechnology and 4% in pharma sector. In contrast in India, only about 3% patent applications are ...
Read more: Indian science and research establishments need a commercial focus: Binod Singh

Pharma Reviews: Ranitidine ban: Indian drug regulator 'alerts' state authorities to ensure patient safety

While many drug regulators across the globe have banned the sale and manufacturing of anti-acidic drug ranitidine until its safety profile is verified ...
Read more: Ranitidine ban: Indian drug regulator 'alerts' state authorities to ensure patient safety