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About 243 results for "us food and drugs administration"

FDA aims to speed up arrival of complex generic drugs

WASHINGTON (Reuters) - The U.S. Food and Drug Administration on Monday announced a series of measures designed to speed to market generic versions of complex drugs such as Mylan NV's emergency EpiPen in an effort to address the rising cost of pharmaceuticals. Reuters, 1 month ago

18 images for us food and drugs administration

First, 1 month ago
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
Reuters, 7 months ago

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 ...
 Prokerala13 hours ago Lupin dives to near 4-year lows on FDA warnings  Sify1 week ago Biocon jumps on green signal for US export  Sify11 hours 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 Control5 days 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
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 US FDA makes 3 observations after inspecting Dr Reddy#39;s plant in UK  Money Control2 months ago Lupin#39;s US arm recalls 12,888 bottles of ulcer drug in US  Money Control2 months ago Lupin recalls contraceptive Mibelas 24 Fe pills in US  Money Control2 months ago
Money Control

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 ...
 Reuters4 days ago FDA backs Roche's Gazyva in first-line follicular lymphoma  Reuters4 days ago FDA approves AstraZeneca's asthma drug  Reuters5 days ago FDA warns against using kratom for opioid addiction  Reuters6 days ago
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
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 USFDA issues CRL for proposed biosimilar Pegfilgrastim: Biocon  Business Standard1 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
Money Control

USFDA hikes fee for processing ANDA by USD 1 lakh for FY18

Citing high workload, the US Food and Drug Administration (USFDA) has increased fee for processing Abbreviated New Drug Application (ANDA) by over USD 1 lakh to USD 1.71 lakh for the fiscal year 2018. The hike was made under Generic Drug User Fee Amendments ...
 Business Standard2 months ago Vista Pharmaceuticals rallies 5% as firm submits ANDA for cardiac drug to USFDA  Money Control1 month ago
Money Control

Cadila Healthcare gains over 2% on USFDA approval for anti-dementia medicine

Zydus Cadila, the group company, today said it has received final approval from the US Food and Drug Administration to market Donepezil Hydrochloride tablets in the strength of 23 mg.
 Money Control2 months ago USFDA clears marketing of Zydus Cadila anti-hypertension drug  Money Control2 months ago
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