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

Pharma Reviews: Enhanced scrutiny has slowed down pharma growth

He also added that Indian pharma industry has to embrace technology and work towards modernisation of its units. “...if you see a hundred-year-old ...
Read more: Enhanced scrutiny has slowed down pharma growth

Pharma Reviews: Frequent FDA inspections slow down Indian pharma exports, says GV Prasad

All there are important things for the industry," Prasad said when asked about the effect of frequent inspections of Indian pharma manufacturing plants ...
Read more: Frequent FDA inspections slow down Indian pharma exports, says GV Prasad

Pharma Reviews: Glenmark Pharma jumps 21% on CLSA upgrade

NEW DELHI: Shares of Glenmark Pharmaceuticals rallied over 21 per cent ... to remain strong whereas India should continue growing above the industry rate. ... The drug firm last week reported a consolidated net profit to Rs 255.54 ...
Read more: Glenmark Pharma jumps 21% on CLSA upgrade

US FDA News: Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Manufactured by Novitium Pharma LLC) Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

Golden State Medical Supply, Incorporated (GSMS, Inc) based upon a manufacturer’s recall by Novitium Pharma LLC (Novitium), is voluntarily instituting a recall of all quantities and lots, within expiry, of Ranitidine HCl 150mg and 300mg Capsules to the consumer level because of potential presence of
Read more: Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Manufactured by Novitium Pharma LLC) Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

Pharma Reviews: Pharma industry needs to develop entire value chain: Dr Reddy's GV Prasad

Indian pharmaceutical companies need to rework their chain of work because of the US-China trade war and China exiting polluting sectors like ...
Read more: Pharma industry needs to develop entire value chain: Dr Reddy's GV Prasad

Pharma Reviews: Few inspectors, no records: Drug regulation in India is hobbled by a number of problems

The Indian pharmaceutical industry, dominated by generic manufacturers, was worth Rs 2.3 lakh crore in 2017. The industry is expected to grow to Rs ...
Read more: Few inspectors, no records: Drug regulation in India is hobbled by a number of problems

Pharma Reviews: Politics | India, RCEP and the China spectre

India's refusal to sign up for the Regional Comprehensive Economic ... and pain its domestic industry and agriculture will face with accession to RCEP, ... While Indian pharma majors have finally begun to see greater opportunities in ...
Read more: Politics | India, RCEP and the China spectre

Pharma Reviews: MARKET LIVE: Sensex, Nifty in the red; metal, pharma, PSU bank stocks gain

India's listed companies, excluding financials and oil and gas, reported a combined net loss for the first time in at least 15 years, while their net sales ...
Read more: MARKET LIVE: Sensex, Nifty in the red; metal, pharma, PSU bank stocks gain

Pharma Reviews: Illegal cancer drugs from B'desh flood local market

Sources said that the Organisation of Pharmaceutical Producers of India (OPPI) recently discussed the matter with the government. The member ...
Read more: Illegal cancer drugs from B'desh flood local market

Pharma Reviews: Moscow Region eyes Indian investment in auto, pharma sectors

The Moscow Region is looking at investment from India in sectors including automotive industry, automotive components, pharmaceuticals and ...
Read more: Moscow Region eyes Indian investment in auto, pharma sectors

US FDA News: Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product

FDA has taken another step to further foster biologics competition with the approval of 25th biosimilar, Abrilada (adalimumab - afzb), a biosimilar to Humira.
Read more: Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product

US FDA News: FDA approves first contact lens indicated to slow the progression of nearsightedness in children

FDA approved the first contact lens to slow the progression of myopia in children, which ultimately could mean a reduced risk of developing other eye problems. MiSight is a daily, disposable contact lens approved for children 8-12 at the start of treatment.
Read more: FDA approves first contact lens indicated to slow the progression of nearsightedness in children

US FDA News: FDA approves first targeted therapy to treat patients with painful complication of sickle cell disease

Today the FDA approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis – a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells – for patients age 16 years and older.
Read more: FDA approves first targeted therapy to treat patients with painful complication of sickle cell disease

US FDA News: FDA clears first duodenoscope with disposable elevator piece, reducing the number of parts needing disinfection

The FDA today cleared the first duodenoscope with a sterile, disposable elevator component that will reduce the number of parts that need to be cleaned and disinfected (reprocessed) in between uses.
Read more: FDA clears first duodenoscope with disposable elevator piece, reducing the number of parts needing disinfection

Pharma Reviews: Live: SGX Nifty Suggests Tepid Start; Aurobindo, Bharti Airtel, SpiceJet, Vedanta In Focus

Indian equity indices rebound from two-week low, led by the gains in private lenders. ... The market breadth, however, was tilted in favour of sellers. ... Aurobindo Pharma said U.S. FDA issued Form 483 with 14 observations after ...
Read more: Live: SGX Nifty Suggests Tepid Start; Aurobindo, Bharti Airtel, SpiceJet, Vedanta In Focus

US FDA News: FDA approves new antibacterial drug to treat complicated urinary tract infections as part of ongoing efforts to address antimicrobial resistance

The FDA today approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients with complicated urinary tract infections (cUTI), including kidney infections caused by susceptible Gram-negative microorganisms, who have limited or no alternative treatment options.
Read more: FDA approves new antibacterial drug to treat complicated urinary tract infections as part of ongoing efforts to address antimicrobial resistance

US FDA News: FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumor shrinkage

FDA has granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.
Read more: FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumor shrinkage

US FDA News: Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10 Male Enhancement Capsules due to an Undeclared PDE-5 Inhibitor Found in The Product

Nature’s Rx is voluntarily recalling lot: 01251ZX1, Expiry Date: 11/2022 of Silver Bullet (10 Male Enhancement Capsules). This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, the active ingredient in Viagra, which is a PDE-5 inhibitor.
Read more: Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10 Male Enhancement Capsules due to an Undeclared PDE-5 Inhibitor Found in The Product

US FDA News: FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugs

FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugs
Read more: FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugs

Pharma Reviews: Pharma exports to US register second-highest growth in last 5 years

An improvement in exports to the US, the key market for Indian drug manufacturers, drove the growth in overall exports from India, although it was ...
Read more: Pharma exports to US register second-highest growth in last 5 years

Product Recall Alerts: Amneal Pharma Recalls Certain Ranitidine Tablets

(RTTNews) - Amneal Pharmaceuticals, LLC recalled certain lots of ... alerting that some Ranitidine medicines, including Zantac over-the-counter or ...
Read more: Amneal Pharma Recalls Certain Ranitidine Tablets

Pharma Reviews: Indian generic firm again fails in Japan; Lupin sells Kyowa

With the divestment of Kyowa Pharmaceutical Industry, Indian drug major Lupin has become the latest to join the list of Indian generic drug makers ...
Read more: Indian generic firm again fails in Japan; Lupin sells Kyowa

Pharma Reviews: Biocon Biologics debuts in Asia IP Elite list

In 2016, Biocon became the first and only Indian pharma company to be featured on the prestigious ASIA IP ELITE list. “This recognition is an ...
Read more: Biocon Biologics debuts in Asia IP Elite list

US FDA News: Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey is voluntarily recalling Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL to the consumer level. A listing of the recalled lots is identified below.
Ranitidine Tablets, USP, 150 mg and 300 mg
Read more: Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

Pharma Reviews: Lupin to sell Japanese unit Kyowa to PE firm Unison Capital

Ltd to a unit of UAE-based pharmaceuticals major Neopharma. ... Indian drug companies continue to remain heavily invested in Japan, which is ...
Read more: Lupin to sell Japanese unit Kyowa to PE firm Unison Capital

Pharma Reviews: This smallcap debt-free company has given 1000% return in the last 10 years

GMM leads the Indian market in glass-lined (GL) steel equipment used in ... With pharma picking up in southern regions like Hyderabad, traction for ...
Read more: This smallcap debt-free company has given 1000% return in the last 10 years

Pharma Reviews: Hundreds of colleges came up amid India's pharma boom. Here's why govt wants no more

New Delhi: High-end salaries, plum foreign jobs and big growth plans for the industry fuelled the setting up of hundreds of pharmacy colleges in India.
Read more: Hundreds of colleges came up amid India's pharma boom. Here's why govt wants no more

Pharma Reviews: Lupin to sell Japanese biz for enterprise value of ₹3702 cr

In 2018-19, Kyowa Pharma had posted sales of 28.3 billion yen, while in the ... Growth was led by sales of drug formulations in its largest market, India.
Read more: Lupin to sell Japanese biz for enterprise value of ₹3702 cr

Pharma Reviews: Top 10 biz headlines: Sun Pharma, IT dept seeks tax mop-up, and more

India's largest drugmaker, Sun Pharmaceutical Industries, is expanding in the Japanese market when most of its peers have indicated they are not ...
Read more: Top 10 biz headlines: Sun Pharma, IT dept seeks tax mop-up, and more

Pharma Reviews: Book Review: The secrets that Indian pharmas harbour

Bottle of Lies, is an extremely well written book, it uncovers the some shameful practices of Indian pharma industry and the institutions and individuals ...
Read more: Book Review: The secrets that Indian pharmas harbour

Pharma Reviews: '4L pharma students graduate every year, they must get jobs'

Rajahmundry: National president of Indian Pharmaceutical Association (IPA) TV Narayana spoke to TOI on the sidelines of the state-level elocution ...
Read more: '4L pharma students graduate every year, they must get jobs'

Product Recall Alerts: America's Unsafe Medical Products

The U.S. Food and Drug Administration (FDA) issued seven new safety alerts in the past week, one safety communication and six product recalls.
Read more: America's Unsafe Medical Products

Pharma Reviews: Sun Pharma ex-employee alleges US Law violation, discrimination

MUMBAI: A former employee of Sun Pharmaceutical Industries, India's largest drug maker, has sued the company, for violating the US False Claims ...
Read more: Sun Pharma ex-employee alleges US Law violation, discrimination

US FDA News: Med Man Issues Voluntary Nationwide Recall of Up2 Due to Presence of Undeclared Sildenafil

Med Man Distribution is voluntarily recalling all lots of Up2 Dietary supplement There is no other all-natural libido for men and women to the consumer level.
Read more: Med Man Issues Voluntary Nationwide Recall of Up2 Due to Presence of Undeclared Sildenafil

US FDA News: American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity

American Health Packaging is voluntarily recalling eight lots of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the f
Read more: American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity

US FDA News: Medtronic Recalls Remote Controllers for MiniMed Insulin Pumps for Potential Cybersecurity Risks

The remote controllers of some Medtronic MiniMed insulin pumps are vulnerable to cybersecurity risks. Unauthorized persons could record and replay the wireless communication from the remote to the MiniMed insulin pump leading to the administration of one ore more unintended boluses of insulin.
Read more: Medtronic Recalls Remote Controllers for MiniMed Insulin Pumps for Potential Cybersecurity Risks

US FDA News: FDA approves first therapy to treat patients with rare blood disorder

FDA grants approval to Reblozyl (luspatercept–aamt) for the treatment of anemia in adult patients with beta thalassemia who require regular red-blood cell transfusions.
Read more: FDA approves first therapy to treat patients with rare blood disorder

Pharma Reviews: Pharma's new world dares Lupin's Vinita Gupta once again. And she is set to fight it out.

Most of India's leading pharmaceutical companies are stuck in one such chaotic logjam. Like its peers, Lupin, the USD2.34 billion Mumbai-based drug ...
Read more: Pharma's new world dares Lupin's Vinita Gupta once again. And she is set to fight it out.

Pharma Reviews: Sun Pharma posts Rs 1064 crore net profit in September quarter, India sales up 35%

Pharma major Sun Pharmaceutical Industries on Thursday reported a consolidated net profit of Rs 1,064.09 crore for the second quarter ended ...
Read more: Sun Pharma posts Rs 1064 crore net profit in September quarter, India sales up 35%

Pharma Reviews: Drug or device? Why India needs separate regulations for medical devices

The vast majority of India's medical devices, a sector which is nearly 80 percent import dependent, are unregulated for quality and safety. While many ...
Read more: Drug or device? Why India needs separate regulations for medical devices

US FDA News: Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 38 Lots of Ranitidine Tablets 150mg, Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL Due to the Detection of NDMA (Nitrosodimethylamine) Impurity

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 1 lot of Ranitidine Tablets 150mg to the retail level and 37 lots of Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL to the consumer level due to the detection of NDMA (Nitrosodimethylamine) Impurity in
Read more: Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 38 Lots of Ranitidine Tablets 150mg, Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL Due to the Detection of NDMA (Nitrosodimethylamine) Impurity

US FDA News: Zimmer Biomet Recalls ROSA Brain 3.0 Robotic Surgery System Due to Software Issue that Incorrectly Positions the Robotic Arm

Zimmer Biomet recalled the ROSA Brain Device due to a software issue which can drive the robotic arm to an incorrect position resulting in risks for the patient.
Read more: Zimmer Biomet Recalls ROSA Brain 3.0 Robotic Surgery System Due to Software Issue that Incorrectly Positions the Robotic Arm

Pharma Reviews: Stocks in the news: YES Bank, Tata Steel, Sun Pharma, DLF and Indiabulls Housing

Tata Steel: The company reported a 6% increase in its net profit in the ... has asked for more information on a lawsuit the Indian company is facing.
Read more: Stocks in the news: YES Bank, Tata Steel, Sun Pharma, DLF and Indiabulls Housing

Pharma Reviews: Centre to infuse Rs 10000 cr into cash-strapped realty sector

Centre to infuse Rs 10,000 cr into cash-strapped realty sector ... to further strengthen cooperation in Indian pharma industry and health care sectors.
Read more: Centre to infuse Rs 10000 cr into cash-strapped realty sector

Pharma Reviews: View: RCEP is important for China ; India has the option to join later on its own terms

India's refusal to join the group, and thus refusal to strengthen it further, ... As it has done with western companies, Beijing wants Indian pharma firms to ...
Read more: View: RCEP is important for China ; India has the option to join later on its own terms

Pharma Reviews: India, NZ hold bilateral talks on health, food safety

... ministers from India and New Zealand on Wednesday agreed to further strengthen cooperation in Indian pharma industry and health care sectors.
Read more: India, NZ hold bilateral talks on health, food safety

Pharma Reviews: Lupin no longer bullish on Japanese market as price rules prove a dampener

Pharmaceuticals major Lupin stayed invested in Japan when most Indian peers quit. Its Japanese subsidiary has grown at a 15 per cent compound ...
Read more: Lupin no longer bullish on Japanese market as price rules prove a dampener

US FDA News: Statement on the agency’s efforts to protect patients through postmarket drug safety surveillance practices

Today, the FDA is issuing an update on efforts to protect patients through postmarket drug safety surveillance practices
Read more: Statement on the agency’s efforts to protect patients through postmarket drug safety surveillance practices

Pharma Reviews: Indian IT companies worst hit as H-1B visa denial rates increase under Trump admin, says report

Indian IT companies worst hit as H-1B visa denial rates increase under Trump ... ALSO READ | Troubles continue for Indian pharma as three major ...
Read more: Indian IT companies worst hit as H-1B visa denial rates increase under Trump admin, says report

Pharma Reviews: Stocks Radar: CG Power, DHFL, Sun Pharma, Titan, Vodafone Idea

Shares of Sun Pharmaceutical Industries Ltd. rose 5.35 percent intraday, the ... India won't back down from collecting $13 billion of past dues from ...
Read more: Stocks Radar: CG Power, DHFL, Sun Pharma, Titan, Vodafone Idea

Pharma Reviews: Troubles continue for Indian pharma as three major drugmakers get new warning letter from FDA

Three major Indian drugmakers received warning letters from the U.S. health ... Indian pharmaceutical factories collectively produce about 40% of the ...
Read more: Troubles continue for Indian pharma as three major drugmakers get new warning letter from FDA

Pharma Reviews: Britain's AstraZeneca to distribute Sun Pharma cancer drugs in China

BENGALURU- Indian drugmaker Sun Pharmaceutical Industries Ltd said on Wednesday it would introduce some of its cancer treatment drugs in ...
Read more: Britain's AstraZeneca to distribute Sun Pharma cancer drugs in China

Pharma Reviews: Big data and predictive analytics: Disrupting Indian healthcare space

Big data and predictive analytics: Disrupting Indian healthcare space ... Major hospitals, healthcare providers, pharma giants and R&D centres are ... at a relatively nascent stage in the Indian healthcare industry as mentioned above.
Read more: Big data and predictive analytics: Disrupting Indian healthcare space

US FDA News: FDA authorizes marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations

Today, the FDA authorized marketing of a test to detect human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next generation sequencing (NGS) technology. It is the first HIV drug resistance assay that uses NGS that the FDA has authorized for marketing in the U.S.
Read more: FDA authorizes marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations

US FDA News: Medtronic Recalls MiniMed Insulin Pumps for Potential Cybersecurity Risks

The remote controllers of some Medtronic MiniMed insulin pumps are vulnerable to cybersecurity risks. Unauthorized persons could record and replay the wireless communication from the remote to the MiniMed insulin pump leading to the administration of one ore more unintended boluses of insulin.
Read more: Medtronic Recalls MiniMed Insulin Pumps for Potential Cybersecurity Risks

US FDA News: UPDATE: The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication

The U.S. Food and Drug Administration (FDA) is updating our 2017 safety communication.
Read more: UPDATE: The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication

US FDA News: The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication

The FDA is alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected.
Read more: The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication

Pharma Reviews: Experts are mulling to group antibiotics into categories to combat misuse

Major pharma lobby groups like Indian Drug Manufacturers'Association (IDMA), ... While some pharma lobby groups are of the view that the third line ...
Read more: Experts are mulling to group antibiotics into categories to combat misuse

Pharma Reviews: In India's RCEP Exit, Domestic Compulsions Sideline Fear of Being Isolated

New Delhi: In the background of intense domestic pressure, India has ... It was also expected that the Indian pharma industry could suffer as a result of ...
Read more: In India's RCEP Exit, Domestic Compulsions Sideline Fear of Being Isolated

Pharma Reviews: Experts laud decision to avoid RCEP, say it will protect industry, farmers

India's decision to not join the mega free-trade agreement RCEP would help ... Presence of China in the grouping has raised concerns as Indian industry ... Several sectors like IT and pharma have time and again flagged issues with ...
Read more: Experts laud decision to avoid RCEP, say it will protect industry, farmers

US FDA News: Abbott Recalls CentriMag Circulatory Support System Motor Due to Pump and Motor Issues

Abbott is recalling their CentriMag System due to a calibration system error resulting from electromagnetic interference (EMI) that may cause low or no flow from the device, the console screen to blank, and various inaccurate alarms.
Read more: Abbott Recalls CentriMag Circulatory Support System Motor Due to Pump and Motor Issues

US FDA News: Philips Medical Systems (Cleveland) Recalls Forte Gamma Camera System Due to Potential for the Detector to Become Detached

The detector on the Forte Gamma Camera System has the potential to become detached without warning which could result in a serious injury or death.
Read more: Philips Medical Systems (Cleveland) Recalls Forte Gamma Camera System Due to Potential for the Detector to Become Detached

US FDA News: Abbot Recalls CentriMag Circulatory Support System Motor Due to Pump and Motor Issues

Abbot is recalling their CentriMag System due to a calibration system error resulting from electromagnetic interference (EMI) that may cause low or no flow from the device, the console screen to blank, and various inaccurate alarms.
Read more: Abbot Recalls CentriMag Circulatory Support System Motor Due to Pump and Motor Issues

Pharma Reviews: GS1 India to host 36th edition of Global GS1 healthcare conference in New Delhi

The Global GS1 healthcare conference will bring together Indian and international regulators, hospitals, drug and device manufacturers, private ...
Read more: GS1 India to host 36th edition of Global GS1 healthcare conference in New Delhi

Pharma Reviews: India's booming appetite for opioids

As major pharmaceutical companies look to capitalise on the opportunity, the playbook unfolding in India seems eerily familiar to the one used in the ...
Read more: India's booming appetite for opioids

Product Recall Alerts: US FDA downplays risk of carcinogen NDMA in already recalled antacid ranitidine

The US FDA had last month issued a safety alert citing traces of NDMA, a known carcinogen, in ranitidine. ... Dr Reddy's Laboratories had also initiated a voluntary recall of the medicine at the retail level in the US on 1 October after ...
Read more: US FDA downplays risk of carcinogen NDMA in already recalled antacid ranitidine

Pharma Reviews: RCEP treaty worries Indian farmers

But also imagine the agony of the Indian dairy keepers and farmers selling milk ... pulses, the home grown steel industry and the Indian pharma sector.
Read more: RCEP treaty worries Indian farmers

Pharma Reviews: Pharma biz has a lot of potential: Experts

Warangal: India has a share of 40 per cent in the pharmacy/drug market globally, Drug Controller General of India Dr Somani said. Inaugurating the ...
Read more: Pharma biz has a lot of potential: Experts

Pharma Reviews: Business Summit, Innovation Hub highlights of Refcold India's '19 essay

The cold chain and refrigeration market in India is expected to reach ... the user industries including quick service restaurants, pharmaceutical industry, ...
Read more: Business Summit, Innovation Hub highlights of Refcold India's '19 essay

Pharma Reviews: Indian drug market will soon rule the world: Dr VG Somani

Warangal Urban: Stating that the pharmacy industry had grown manifold in the country, Dr VG Somani, Drug Controller General of India (DCGI), said ...
Read more: Indian drug market will soon rule the world: Dr VG Somani

US FDA News: Fagron Inc. Issues Voluntary Nationwide Recall of LETS GEL KIT Convenience Packs Due to Potential Microbial Contamination of Non-Sterile Products

Voluntarily Recalling all unexpired lots of LETS GEL KIT Convenience Packs to the hospital, pharmacy and distributor level. The product has been found to potentially contain microbial contamination in the non-sterile Suturagel Methylcellulose base component of the LETS GEL KIT Convenience Packs.
Read more: Fagron Inc. Issues Voluntary Nationwide Recall of LETS GEL KIT Convenience Packs Due to Potential Microbial Contamination of Non-Sterile Products

US FDA News: Statement on new testing results, including low levels of impurities in ranitidine drugs

Today, the FDA is issuing an update on new testing results, including low levels of impurities in ranitidine drugs
Read more: Statement on new testing results, including low levels of impurities in ranitidine drugs