US FDA News: La FDA ayuda a facilitar el comercio entre los socios comerciales estadounidenses y extranjeros con un nuevo programa de certificación de exportaciones para los alimentos

La FDA ayuda a facilitar el comercio entre los socios comerciales estadounidenses y extranjeros con un nuevo programa de certificación de exportaciones para los alimentos
Read more: La FDA ayuda a facilitar el comercio entre los socios comerciales estadounidenses y extranjeros con un nuevo programa de certificación de exportaciones para los alimentos

US FDA News: FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

FDA is warning the public about a voluntary recall of one lot of montelukast sodium tablets made by Camber Pharmaceuticals due to incorrect drug in bottles
Read more: FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

US FDA News: FDA helps facilitate trade between U.S. and foreign trading partners with new export certification program for food

FDA helps facilitate trade between U.S. and foreign trading partners with new export certification program for food
Read more: FDA helps facilitate trade between U.S. and foreign trading partners with new export certification program for food

Pharma Reviews: India's half-baked medical-device regulation won't reduce patients' sufferings or rein in errant firms

The Indian medical-device industry is worth USD5.2 billion, growing at a CAGR of 15.8%, faster than many global markets. The import-dependent ...
Read more: India's half-baked medical-device regulation won't reduce patients' sufferings or rein in errant firms

US FDA News: District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs

The U.S. District Court for the District of New Jersey entered an order of permanent injunction against S Hackett Marketing LLC doing business as Just Enhance; R Thomas Marketing LLC; Shawn Hackett, president and owner of Just Enhance; and Roger Thomas, president and founder of R Thomas Marketing LLC. The permanent injunction requires the defendants to, among other things, cease the distribution of drugs until they take specific remedial measures and comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Read more: District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs

Pharma Reviews: India-Japan partnership group led by Sanjeev Sinha holds 'India-Japan Healthcare Forum'

Sunil Rajput, President of IJPG Kyoto Kashi, working on pharmaceutical technology transfer from Japan to India, among other domains, made the ...
Read more: India-Japan partnership group led by Sanjeev Sinha holds 'India-Japan Healthcare Forum'

Pharma Reviews: Not biggies, go for these niche pharma cos: Dipan Mehta

As far as Indian MNC pharma companies are concerned, buy them on correction, says Dipan Mehta, Member, BSE & NSE. Mehta is bullish on Suven ...
Read more: Not biggies, go for these niche pharma cos: Dipan Mehta

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s ongoing investigation into valsartan impurities and recalls and an update on FDA’s current findings

FDA update on the ongoing investigation into valsartan impurities, recalls and current findings.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s ongoing investigation into valsartan impurities and recalls and an update on FDA’s current findings

Product Recall Alerts: Quality Failures at Foreign Manufacturers Prompt Warnings and Recalls

FDA has been issuing warning letters and managing new import bans and product recalls related to a wave of potentially impure drugs and APIs from ...
Read more: Quality Failures at Foreign Manufacturers Prompt Warnings and Recalls

Pharma Reviews: City-based pharma tycoon accused of assault by wife

The tycoon inherited the pharma business from his father, who is hailed today for ushering in dawn of a new era in Indian pharma industry immediately ...
Read more: City-based pharma tycoon accused of assault by wife

Pharma Reviews: Maharashtra Druggists' body to pharma firms: 'Refrain from unethical practices to boost sales'

Talking to The Indian Express, Mehta said: “The complete pharma industry is focused on increasing the sales… So, there is immense pressure on the ...
Read more: Maharashtra Druggists' body to pharma firms: 'Refrain from unethical practices to boost sales'

US FDA News: SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

Requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.
Read more: SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area

Pharma Reviews: Domestic pharma players eye Bharat Serums acquisition

MUMBAI: Domestic pharmaceutical companies Cipla, Zydus Cadilla, ... India's biotech industry currently has a 2% share of the global market and is ...
Read more: Domestic pharma players eye Bharat Serums acquisition

Pharma Reviews: WinMagic provides healthcare information security and privacy

Mr. Rahul Kumar- Country Manager, India & APAC, WinMagic Corp in a ... 8) How does WinMagic play an important role in Indian pharma sector to ...
Read more: WinMagic provides healthcare information security and privacy

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s support for exempting coffee from California’s cancer warning law

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s support for exempting coffee from California’s cancer warning law
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s support for exempting coffee from California’s cancer warning law

US FDA News: Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis

Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis.
Read more: Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis

US FDA News: FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products

FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products
Read more: FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products

US FDA News: FDA takes action against 21 websites marketing unapproved opioids as part of agency’s effort to target illegal online sales

FDA takes action against 21 websites marketing unapproved opioids as part of agency’s effort to target illegal online sales
Read more: FDA takes action against 21 websites marketing unapproved opioids as part of agency’s effort to target illegal online sales

Pharma Reviews: Indian drug makers see hike in Chinese raw material as an opportunity to produce locally

There are around 7,000 active pharmaceutical ingredient manufacturers in China, catering to around 80 percent of India drug makers' raw material ...
Read more: Indian drug makers see hike in Chinese raw material as an opportunity to produce locally

Pharma Reviews: CDSCO issues FAQs on new phytopharmaceuticals to help industry in manufacture, clinical trials ...

“It is hoped that Indian pharma R&D companies and the academia will try to develop botanical drugs in addition to be labelled as the 'copy cat' and ...
Read more: CDSCO issues FAQs on new phytopharmaceuticals to help industry in manufacture, clinical trials ...

Pharma Reviews: NIPER looks to bridge academia-industry gap

He was speaking at Synergy 2018, a NIPER-Pharma Industry meet here on 'Role of academia in strengthening of the Indian Pharma and Intellectual ...
Read more: NIPER looks to bridge academia-industry gap

Pharma Reviews: OPF to organize 'Pharmanecia 2018' to promote academy-industry interactions in pharmacy ...

While briefing Pharmabiz about the conference, he said the primary goal of the Pharmanecia 2018 is to mobilize support of Indian pharma industry for ...
Read more: OPF to organize 'Pharmanecia 2018' to promote academy-industry interactions in pharmacy ...

Pharma Reviews: Pharma firms stung by rise in raw material costs

According to the Indian Drugs Manufacturers Association (IDMA), more than 90 ... Indian Institute of Chemical Technology to encourage raw material ...
Read more: Pharma firms stung by rise in raw material costs

Pharma Reviews: Pharma industry associations seek hike in ceiling prices of NLEM drugs as API prices rise ...

There is an extraordinary increase in prices of active pharmaceutical ... DG Shah, secretary general of Indian Pharmaceutical Alliance said “Prices and ...
Read more: Pharma industry associations seek hike in ceiling prices of NLEM drugs as API prices rise ...

Pharma Reviews: US FDA officials visit Gujarat FDCA for capacity building towards global regulatory harmonization

A team of US FDA officials recently visited Gujarat Food and Drug Control ... in Gujarat towards audit preparedness for the Indian pharma industry.
Read more: US FDA officials visit Gujarat FDCA for capacity building towards global regulatory harmonization

Pharma Reviews: APPQM programme helps 24 cos demonstrate gains in bottomline, enhance compliance and ...

Conducted for the first time in India, IDMA and UK-based NSF International collaborated to jointly start APPQM for professionals of pharmaceutical ...
Read more: APPQM programme helps 24 cos demonstrate gains in bottomline, enhance compliance and ...

Pharma Reviews: Wasazra Pharmaceuticals Plans to Expand its Presence PAN India

Wasazra is one of the emerging pharmaceutical companies in India, whose goal is to ensure that no patient is denied access to high quality ...
Read more: Wasazra Pharmaceuticals Plans to Expand its Presence PAN India

Pharma Reviews: India: Access And Benefit Sharing Under CBD And The Ayurveda Industry

Patanjali pleaded in the Court that it being an Indian company hence, ABS compliance is not applicable to it. In 2015, the Ayurvedic Drug ...
Read more: India: Access And Benefit Sharing Under CBD And The Ayurveda Industry

US FDA News: Companies cease sales of e-liquids with labeling or advertising that resembled kid-friendly foods following FDA, FTC warnings

FDA announced that all 17 manufacturers, distributors, and retailers that were warned in May have stopped selling the e-liquids used in e-cigarettes with labeling or advertising resembling kid-friendly food products.
Read more: Companies cease sales of e-liquids with labeling or advertising that resembled kid-friendly foods following FDA, FTC warnings

US FDA News: FDA approves first drug for neurotrophic keratitis, a rare eye disease

FDA approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye).
Read more: FDA approves first drug for neurotrophic keratitis, a rare eye disease

Pharma Reviews: Wasazra Pharmaceuticals Plans to Expand its Presence PAN India

We plan to become a recognized brand in pharma industry. Wasazra being an Indian company and promoted under Make in India, we have a huge ...
Read more: Wasazra Pharmaceuticals Plans to Expand its Presence PAN India

US FDA News: Statement by FDA Commissioner Scott Gottlieb, M.D., on new steps to advance the development of evidence-based, indication-specific guidelines to help guide appropriate prescribing of opioid analgesics

FDA awarded a contract to the National Academies of Sciences, Engineering, and Medicine to advance the development of evidence-based, indication-specific guidelines to help guide appropriate opioid prescribing.
Read more: Statement by FDA Commissioner Scott Gottlieb, M.D., on new steps to advance the development of evidence-based, indication-specific guidelines to help guide appropriate prescribing of opioid analgesics

Pharma Reviews: Ajay Bhatt joins Intas Pharmaceuticals as the Global President for HR

Intas Pharmaceuticals has appointed Ajay Bhatt as President- Global ... He has previously been associated with leading Indian Pharmaceutical majors ...
Read more: Ajay Bhatt joins Intas Pharmaceuticals as the Global President for HR

Pharma Reviews: Novartis supportive of Donald Trump's drug policy: CEO Vasant Narasimhan

New Delhi: The pharmaceutical industry has been put on the defensive about the .... How does the Indian government think about data protection?
Read more: Novartis supportive of Donald Trump's drug policy: CEO Vasant Narasimhan

Pharma Reviews: Rupee fall seen boosting margins of IT, pharma firms

Indian information technology (IT) and pharmaceutical firms, and select auto ancillary units, which earn a large part of their revenues in dollars, are ...
Read more: Rupee fall seen boosting margins of IT, pharma firms

Pharma Reviews: India to use 'India-Japan Medical Products Regulatory symposium' to explore opportunity for ...

Japan being a highly regulated and tough market to venture into for Indian exports, Department of Commerce, Government of India, along with ...
Read more: India to use 'India-Japan Medical Products Regulatory symposium' to explore opportunity for ...

Pharma Reviews: How "sea turtles" are making China a hotbed of biotech innovation

As Indian pharmaceutical majors come to terms with an unprecedented downturn in sales of generic drugs in the key US market, China has entered ...
Read more: How "sea turtles" are making China a hotbed of biotech innovation

Pharma Reviews: Ibuprofen API prices jump 30% in international market due to supply crunch

The API or bulk drug (raw material) of Ibuprofen has seen supply shortages in the past nine months, first because of production disruption in India in ...
Read more: Ibuprofen API prices jump 30% in international market due to supply crunch

Pharma Reviews: Hyderabad to host three pharma exhibitions

Hyderabad: lndian Pharma Machinery Manufacturers Association (IPMMA) has entered into a collaboration agreement with Messe Muenchen India to ...
Read more: Hyderabad to host three pharma exhibitions

Pharma Reviews: PharmaLytica 2018 Closes on a High Note

The fifth edition of PharmaLytica, hosted by UBM India, successfully ... of the Pharma industry with a whooping increase of 24% in visitor footfalls.
Read more: PharmaLytica 2018 Closes on a High Note

Pharma Reviews: Coca-Cola India announces changes in its leadership team

Coca-Cola India has roped in Chandrasekar Radhakrishnan as ... Indian pharma company Intas Pharmaceuticals has appointed Ajay Bhatt as ...
Read more: Coca-Cola India announces changes in its leadership team

Pharma Reviews: TN govt contributes drugs worth Rs.20 lakhs to flood hit Kerala as medicines & nutritional ...

A Kannan, president of the marketers' body, Consortium of Indian Pharmaceutical Marketers & Manufacturers Association (CIPMMA), said their district ...
Read more: TN govt contributes drugs worth Rs.20 lakhs to flood hit Kerala as medicines & nutritional ...

Pharma Reviews: There's an explosion of data & digital opportunities in Indian healthcare: Vasant Narasimhan, CEO ...

Earlier this year Vasant “Vas” Narasimhan (42) was named the CEO of Novartis, the $50 billion Swiss pharmaceutical behemoth. An American of ...
Read more: There's an explosion of data & digital opportunities in Indian healthcare: Vasant Narasimhan, CEO ...

Product Recall Alerts: BRIEF—FDA alerts drugmakers of a recall of porcine thyroid API from China

The US Food and Drug Administration is alerting active pharmaceutical ingredient (API) repackagers and distributors, finished drug manufacturers, ...
Read more: BRIEF—FDA alerts drugmakers of a recall of porcine thyroid API from China

Pharma Reviews: Closing bell: Nifty closes at record high, Sensex surges 284 points powered by banking stocks

Members of the Reserve Bank of India's Monetary Policy Committee .... shares rise on receipts drug marketing approvalAstraZeneca Pharma India Ltd ...
Read more: Closing bell: Nifty closes at record high, Sensex surges 284 points powered by banking stocks

Pharma Reviews: India looks beyond US markets for its pharma exports, achieves positive growth despite 8% decline ...

Earlier, there was always a worry for the Indian pharma industry that if the growth in US markets is declined then there will be an overall impact of the ...
Read more: India looks beyond US markets for its pharma exports, achieves positive growth despite 8% decline ...

Pharma Reviews: Pharma Pro&Pack 2018 to take place from Sept 6-8 in Hyderabad.

Taking place at the pharmaceutical hub of India- Hyderabad, which is home to about 1,000 plus pharmaceutical companies, the exhibition will be ...
Read more: Pharma Pro&Pack 2018 to take place from Sept 6-8 in Hyderabad.

US FDA News: Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke

FDA has reviewed the final results from the post-approval study conducted by SynCardia Systems, LLC. for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System (CSS) Console.
Read more: Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke

US FDA News: FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder

FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder
Read more: FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder

Product Recall Alerts: Health Alerts: Baby wash, pajamas, snowboard boots, and more recalled

Baby wash recalled due to possible health risks. Hazard: The baby wash might contain the bacteria Pseudomonas aeruginosa. The bacteria can ...
Read more: Health Alerts: Baby wash, pajamas, snowboard boots, and more recalled

US FDA News: FDA approves first generic version of EpiPen

FDA approves the first generic version of EpiPen and EpiPen Jr for the emergency treatment of allergic reactions in adults and pediatric patients who weigh more than 33 pounds.
Read more: FDA approves first generic version of EpiPen

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans

FDA announces workshop on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on significant public health value and cost savings resulting from the agency’s youth smoking prevention campaign

A cost-effectiveness analysis of the FDA’s “The Real Cost” youth smoking prevention campaign shows it has resulted in savings of more than $31 billion for youth, their families and society at large.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on significant public health value and cost savings resulting from the agency’s youth smoking prevention campaign

Pharma Reviews: Spike in Chinese raw material prices hits Indian drug-makers

As per the data available with Pharmaceutical Export Promotion Council (Pharmexcil), India imports worth $6 to $7 billion raw materials from China for ...
Read more: Spike in Chinese raw material prices hits Indian drug-makers

Pharma Reviews: Prabhu to visit Uzbekistan to promote trade, economic ties

India's exports to Uzbekistan mainly comprise pharmaceutical products, mechanical equipment, vehicle parts, services, optical instruments and ...
Read more: Prabhu to visit Uzbekistan to promote trade, economic ties

US FDA News: Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new resource guide to support responsible opioid prescribing for pain management in animals

Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new resource guide in support of responsible opioid prescribing for safe, effective pain management in animals
Read more: Statement by FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new resource guide to support responsible opioid prescribing for pain management in animals

Pharma Reviews: Digitalization could lead to operational excellence in Pharma Manufacturing:Bhalgat

Speaking at a session on “Digitalization of Pharma Manufacturing “ organised by Confederation of Indian Industry here on Tuesday, Dr Mahesh said ...
Read more: Digitalization could lead to operational excellence in Pharma Manufacturing:Bhalgat

Pharma Reviews: Healthcare/Pharma best rated sector in Aug2018:JobBuzz Workplace Index

August 14, 2018, New Delhi: Indian Inc employees adjudged Healthcare/Pharmaceuticals sector as the best sector to work for in July 2018, revealed ...
Read more: Healthcare/Pharma best rated sector in Aug2018:JobBuzz Workplace Index

Pharma Reviews: Digitisation of pharma manufacturing has many applications: Experts

Speaking at a conference on digitisation of pharma manufacturing organised by the Confederation of Indian Industry here on Tuesday, Bhalgat said ...
Read more: Digitisation of pharma manufacturing has many applications: Experts

Pharma Reviews: Rupee breaches the 70 mark: How it's bad, and how it's good

Indian rupee hit a record low of 70.07 a dollar on Tuesday. ... For example, information technology and pharma companies benefit from a weak rupee ...
Read more: Rupee breaches the 70 mark: How it's bad, and how it's good

Pharma Reviews: Closing bell: Sensex gains 207 points; Nifty settles at 11435; Sun Pharma shares surge 7% after ...

Sun Pharma, Yes Bank, ICICI Bank, Reliance Industries and Axis Bank .... multiplex operator boost its presence in the lucrative south Indian market.
Read more: Closing bell: Sensex gains 207 points; Nifty settles at 11435; Sun Pharma shares surge 7% after ...

Pharma Reviews: India to face acute dearth of productive and employable pharmacy graduates: Uma Nandan Misra

Indian pharma industry will have to face the brunt of untrained pharmacists in the coming years as the graduates and post graduates of pharmacy are ...
Read more: India to face acute dearth of productive and employable pharmacy graduates: Uma Nandan Misra

Pharma Reviews: Experts allay fears of Indian patients as valsartan drug recall widens over carcinogenic chemical

Though valsartan is a key component in various life-saving drugs sold in the domestic market, many Indian companies obtain the bulk drug ...
Read more: Experts allay fears of Indian patients as valsartan drug recall widens over carcinogenic chemical

Pharma Reviews: Carlyle in talks to invest $100 million in BDR Pharma

India's pharma market though reeling under pressures of price cuts has seen a nearly 12% growth showing signs of recovery. For PE players like ...
Read more: Carlyle in talks to invest $100 million in BDR Pharma

Pharma Reviews: Pharmexcil to sign MoU with China trade body for faster drug approvals

In a bid to boost the India-China pharmaceutical trade, the Pharmaceuticals Export Promotion Council of India (Pharmexcil), under the Ministry of ...
Read more: Pharmexcil to sign MoU with China trade body for faster drug approvals

Pharma Reviews: Two-day PharmaLytica-2018 at Hyderabad showcases advanced, innovative technological trends ...

Therefore, the need of the hour for the Indian pharmaceutical players is to achieve maximum efficiency with better product and service offerings.”
Read more: Two-day PharmaLytica-2018 at Hyderabad showcases advanced, innovative technological trends ...

Pharma Reviews: PharmaLytica 2018 highlights Quality Culture and Regulatory Compliance trends of the Pharma ...

(L-R- Uday Bhaskar Reddy, Director General, PHARMEXCIL; Yogesh Mudras, Managing Director, UBM India; Dr R B Smarta, MD, Interlink Marketing ...
Read more: PharmaLytica 2018 highlights Quality Culture and Regulatory Compliance trends of the Pharma ...

Pharma Reviews: Our partnership is focused on unlocking business value by working on pharma manufacturing ...

Pharmaceutical manufacturing is a very complex game. You have to not only ... How has Rockwell Automation benefited the Indian pharma sector ?
Read more: Our partnership is focused on unlocking business value by working on pharma manufacturing ...

Pharma Reviews: Indo-China talks put on fast track to bring down drug approval timeline & import tariff on priority ...

India is a global leader in specialty generics. Speedy approval will provide opening to Indian drug makers to market their economically priced drugs in ...
Read more: Indo-China talks put on fast track to bring down drug approval timeline & import tariff on priority ...

Pharma Reviews: Pharma exports to cross USD 19 bn in FY19: Pharmexcil

North America, the largest market for Indian Pharma exporters, witnessed a negative growth of 7.35 per cent to USD 5.35 billion in FY 18 against USD ...
Read more: Pharma exports to cross USD 19 bn in FY19: Pharmexcil

Pharma Reviews: 'New markets opening up for pharma exports'

New markets are expected to drive the growth of Indian pharma exports, in spite of headwinds in the traditional US market.“ ...
Read more: 'New markets opening up for pharma exports'

Pharma Reviews: Pharma exports up 3 per cent in FY18

“Even if negative growth continues in the US market, the Indian Pharma ... Yogesh Mudras, Managing Director, UBM India said, “The Indian Pharma ...
Read more: Pharma exports up 3 per cent in FY18

Pharma Reviews: Pharma exports touch $ 17.26 billion

“This development will augur well for the Indian pharma industry and will result in increasing exports, both in volumes and value,” Bhaskar said.
Read more: Pharma exports touch $ 17.26 billion

Pharma Reviews: PharmaLytica showcasing new age tools

The event is supported by Pharmexcil, Confederation of Indian Pharmaceutical Industry (CiPi) and the Indian Drug Manufacturers' Association (IDMA).
Read more: PharmaLytica showcasing new age tools

Pharma Reviews: PharmaLytica 2018 Showcases the Latest in Quality Assurance Technology Quality Culture and ...

A premier industry event in South India by UBM India ... Therefore, the need of the hour for the Indian pharmaceutical players is to achieve maximum ...
Read more: PharmaLytica 2018 Showcases the Latest in Quality Assurance Technology Quality Culture and ...

Pharma Reviews: Indian Pharma exports reaches USD 17 26 bn in 2017-18 : Reddy

For the first time Indian Pharmaceutical exports grew by 2.29 per cent in the FY 2017-18 when 8 per cent negative growth reported in US market.
Read more: Indian Pharma exports reaches USD 17 26 bn in 2017-18 : Reddy

Pharma Reviews: True North in talks to buy into Glenmark's API biz for Rs 1500 cr

Glenmark's Active Pharmaceutical Ingredients (API) division manufactures ... Indian Government's move is expected to boost the API manufacturing ...
Read more: True North in talks to buy into Glenmark's API biz for Rs 1500 cr

US FDA News: FDA approves new treatment for a rare genetic disorder, Fabry disease

FDA approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease.
Read more: FDA approves new treatment for a rare genetic disorder, Fabry disease

US FDA News: FDA approves new vaginal ring for one year of birth control

FDA approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year.
Read more: FDA approves new vaginal ring for one year of birth control

US FDA News: FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves new drug for treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for this rare, debilitating and often fatal genetic disease and the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.
Read more: FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

US FDA News: FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy

The app uses basal body temperature readings to predict when a woman is most fertile to help her avoid conceiving on those days if using as a form of contraception
Read more: FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy

Product Recall Alerts: Recalling defective vaccines will deal heavy blow to China's drug exports: experts

... medicine and ingredients, after several Chinese drug makers reportedly recalled their products over safety concerns that triggered a global alert.
Read more: Recalling defective vaccines will deal heavy blow to China's drug exports: experts

Product Recall Alerts: Govt urged to strengthen supervision on drug exports

The recall triggered a global alert over a similar issue. Two other drug makers from the Chinese mainland, Tianyu Pharm and Rundu Pharma, recalled ...
Read more: Govt urged to strengthen supervision on drug exports

Pharma Reviews: Rajasthan drug regulator: Brands of 4 firms substandard

Rajasthan's drug regulator found the drug brands of four major companies ... However, the companies told The Indian Express on Thursday that the ...
Read more: Rajasthan drug regulator: Brands of 4 firms substandard

Pharma Reviews: Pharmaceutical exports up 3% to $17.3 billion in 2017-18

India's pharmaceutical exports grew merely 3 percent to $17.3 billion in 2017-18 due to increasing regulatory concerns and pricing pressures in the ...
Read more: Pharmaceutical exports up 3% to $17.3 billion in 2017-18

Pharma Reviews: Pharma exports up 3 pc to USD 17.3 bn in 2017-18

New Delhi, Aug 9 () India's pharmaceutical exports grew merely 3 per cent to USD 17.3 billion in 2017-18 due to increasing regulatory concerns and ...
Read more: Pharma exports up 3 pc to USD 17.3 bn in 2017-18

Pharma Reviews: Pharma exports up 3 pc to $17.3 billion in 2017-18

India's pharmaceutical exports grew merely 3 per cent to USD 17.3 billion in 2017-18 due to increasing regulatory concerns and pricing pressures in ...
Read more: Pharma exports up 3 pc to $17.3 billion in 2017-18

Pharma Reviews: Pharma exports grow 3% to $17.3 bn in FY18

New Delhi: India's pharmaceutical exports grew merely 3 per cent to USD 17.3 billion in 2017-18 due to increasing regulatory concerns and pricing ...
Read more: Pharma exports grow 3% to $17.3 bn in FY18

Pharma Reviews: Advantage India: How China-US trade war has opened exports opportunity for Indian Pharma

It is the largest export destination for the Indian pharmaceutical market accounting for 12.5% share in case of bulk drugs and 39.8% share in India's ...
Read more: Advantage India: How China-US trade war has opened exports opportunity for Indian Pharma

Pharma Reviews: ACCEPT FDC ORDER

Over the years, the pharmaceutical market in India was flooded with FDCs and subsequently there were outcries from the experts about the safety and ...
Read more: ACCEPT FDC ORDER

US FDA News: Risks Associated with Use of Rupture of Membranes Tests - Letter to Health Care Providers

The FDA is reminding health care providers that tests to detect rupture of the amniotic membranes should not be used without other clinical assessments to make critical patient management decisions.
Read more: Risks Associated with Use of Rupture of Membranes Tests - Letter to Health Care Providers

US FDA News: FDA alerts healthcare providers, women about risks associated with improper use of rupture of membranes tests

FDA alerts healthcare providers, women about risks associated with improper use of rupture of membranes tests
Read more: FDA alerts healthcare providers, women about risks associated with improper use of rupture of membranes tests

US FDA News: FDA approves treatment for two rare types of non-Hodgkin lymphoma

FDA approves new drug for the treatment of adults with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy
Read more: FDA approves treatment for two rare types of non-Hodgkin lymphoma

US FDA News: FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs

FDA approves first generic drug under Competitive Generic Therapy (CGT) designation for products with inadequate generic competition
Read more: FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs

Pharma Reviews: After Abbott's heartache, a little-known Indian company is poised to change the world of stents

In the pharmaceutical industry, a first-in-class or first-generation product comes ... In India, controversies around the pricing of coronary stents have ...
Read more: After Abbott's heartache, a little-known Indian company is poised to change the world of stents

Pharma Reviews: Mounting resistance: India reviews RCEP plan, forms GoM

India, however, feels while most RCEP members want New Delhi to commit ... The pharma industry, too, fears that cheap Chinese products will have ...
Read more: Mounting resistance: India reviews RCEP plan, forms GoM

Pharma Reviews: Regional Comprehensive Economic Partnership: GoM to assess if trade pact in India's interest

India is having second thoughts on whether to join the 16-nation Regional ... The pharma industry, too, fears that cheap Chinese products will have ...
Read more: Regional Comprehensive Economic Partnership: GoM to assess if trade pact in India's interest

US FDA News: FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder

FDA issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment drugs to treat opioid use disorder.
Read more: FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder

Pharma Reviews: Hyderabad to host PharmaLytica

The expo is supported by associations including Pharmexcil, Confederation of Indian Pharmaceutical Industry (CiPi) and Indian Drug Manufacturers' ...
Read more: Hyderabad to host PharmaLytica

Pharma Reviews: The cure for India-China relations

The Chinese tourists travel to India to buy generic cancer and other drugs in bulk. The Indian pharmaceutical industry, which exports pharmaceuticals ...
Read more: The cure for India-China relations

Pharma Reviews: US proposal on drug pricing may shake up Indian pharma

This same change in law poses a potentially-existential challenge to certain India-based generics manufacturers. Increased price transparency will ...
Read more: US proposal on drug pricing may shake up Indian pharma

US FDA News: Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant

The antibiotic Zithromax, Zmax (azithromycin) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients.
Read more: Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps the agency is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes

FDA releases the first of two draft guidances aimed at supporting the development of novel, inhaled nicotine replacement therapies that could be submitted for approval as new drugs.
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps the agency is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes

Pharma Reviews: Ajanta Pharma plans big US push

Ajanta Pharma, one of the fastest growing and leading mid-sized Indian drug companies, is planning a mega push into the US drug market. Ajanta has ...
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Pharma Reviews: How Edsel Pereira revitalized Glenmark Pharmaceuticals with a booster dose of IT innovations

Since data plays a vital role in the pharmaceutical industry, we have ... One of the critical challenges that India pharma industry faces is of duplicate ...
Read more: How Edsel Pereira revitalized Glenmark Pharmaceuticals with a booster dose of IT innovations

US FDA News: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s continued, careful oversight of the REMS associated with transmucosal immediate-release fentanyl products

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s continued, careful oversight of the REMS associated with transmucosal immediate-release fentanyl products
Read more: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s continued, careful oversight of the REMS associated with transmucosal immediate-release fentanyl products