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About 244 results for "us food and drug administration"

USFDA delivers strong message to pharma companies on quality culture & data integrity
Money Today

USFDA delivers strong message to pharma companies on quality c...

The US Food and Drug Administration (USFDA) seems to have sent out a strong message to pharmaceutical companies in India on the need to adhere to a quality culture and on matters relating to data integrity. This was as part of 'Advanced GMP (good ... Money Today, 1 day ago
Glenmark gets USFDA clearance for contraceptive drug Business Standard, 6 hours ago
Ajanta Pharma will be watched after USFDA nod for drug Business Standard, 6 hours ago

19 images for us food and drug administration

Money Today, 1 day ago
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Money Control, 2 months ago
Sify, 5 months ago
Money Control, 2 months ago
Reuters, 5 months ago
Reuters, 6 months ago
The Telegraph UK, 1 month ago
Money Control, 5 months ago
Money Control, 3 weeks ago
Money Control

Dr Reddy#39;s gets EIR for Vizag plant, but inspection not closed

It, however, said the US Food and Drug Administration has not closed the inspection and the manufacturing site#39;s status remains unchanged.
 Money Control1 day ago US FDA makes 3 observations after inspecting Dr Reddy#39;s plant in UK  Money Control2 months ago Dr Reddy's gets EIR for Vizag plant, but inspection not closed  Business Standard1 day ago Marksans Pharma gets EIR from USFDA for its Goa facility  Business Standard1 month ago
Sify

US regulator audits Biocon drug facility in Bengaluru

Indian biotech major Biocon Ltd on Monday said the US Food and Drug Administration (FDA) had audited its aseptic drug product facility here and issued an establishment inspection report on its current good manufacturing practice."The FDA had audited our drug ...
 Prokerala2 days ago Biocon jumps on green signal for US export  Sify2 days ago Lupin dives to near 4-year lows on FDA warnings  Sify2 weeks ago
Business Standard

USFDA lifts import alert on Divi#39;s Laboratories unit

Last week, the company in a regulatory filing had said the US Food and Drug Administration (USFDA) had "closed out" a warning letter issued to the unit in Visakhapatnam following evaluation of corrective actions taken by the company at the plant.
 Money Control1 week ago USFDA lifts import alert on Divi's Vizag plant  Business Standard2 weeks ago Nifty fails to hold 10,450, Midcap outperforms Sensex; Divis Labs lifts Pharma index 3%  Money Control2 weeks ago USFDA to lift import alert on Vizag unit: Divi's Labs  Business Standard2 weeks ago
Med India

FDA expands approval for Pfizer cancer drug Sutent

The U.S. Food and Drug Administration on Thursday approved the use of Pfizer Inc’s cancer drug Sutent to help prevent kidney cancer from returning following surgical removal of a kidney. FILE PHOTO: The Pfizer logo is seen at their world headquarters in ...
 Reuters5 days ago FDA backs Roche's Gazyva in first-line follicular lymphoma  Reuters5 days ago FDA approves AstraZeneca's asthma drug  Reuters1 week ago FDA warns against using kratom for opioid addiction  Reuters1 week ago
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Business Standard

Biocon rises 3% on complete response letter for proposed biosimilar pegfilgrastim

The US Food and Drug Administration has issued a complete response letter (CRL) for Mylan#39;s biologics license application (BLA), a proposed biosimilar pegfilgrastim.
 Money Control1 month ago Biocon gets CRL from USFDA for anti-cancer drug  Business Standard1 month ago Biocon receives CRL from USFDA for anti-cancer drug  Business Standard1 month ago USFDA issues CRL for proposed biosimilar Pegfilgrastim: Biocon  Business Standard1 month ago
Money Control

Dr Reddy#39;s Laboratories recalls Famotidine tablets from US market

According to a notification put up by the US Food and Drug Administration, the recall is being made under #39;Class-III#39; classification, which is described as #39;a situation in which use of or exposure to a violative product is not likely to cause adverse ...
 Money Control1 month ago Lupin#39;s US arm recalls 12,888 bottles of ulcer drug in US  Money Control2 months ago Dr Reddy's Lab recalls Famotidine tablets from US market  Business Standard1 month ago Dr Reddy's recalls over half a million Famotidine tablet bottles in US  Business Standard1 month ago
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Money Control

FDA nod to Natco's marketing partner Mylan for generic

Natco Pharma today said its marketing partner Mylan has received approval from the US Food and Drug Administration (FDA) for the generic version of multi-billion dollar multiple sclerosis drug - Copaxone - of Teva Pharmaceuticals.The news gave fillip to the ...
 Business Standard1 month ago Natco Pharma locked at 20% upper circuit as partner Mylan gets USFDA nod for multiple sclerosis drug  Money Control1 month ago

Divis Labs tanks 9% after USFDA issues 6 observations to Vizag unit 2

After inspecting the plant during September 11-19, the US Food and Drug Administration has issued six observations including failure in testing individual batches and inadequate cleaning instructions.
 Money Control1 month ago Cadila Healthcare soars 5% on zero observations from USFDA for Moraiya unit  Money Control2 months ago
catchnews.com

Many drug companies fail to conduct timely safety checks on medicines after FDA approval

(Reuters Health) - In the rush to approve new medicines, the U.S. Food and Drug Administration often requires drug companies to study possible side effects and alternative doses for medicines once they hit the broader market. A new analysis in the New England ...
 Reuters2 months ago FDA OKs Merck drug that prevents infection post-stem cell transplant  Reuters1 week ago Three reasons why pacemakers are vulnerable to hacking  catchnews.com2 months ago FDA approves Medicines Co's urinary tract infection drug  Reuters2 months ago
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