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About 1030 results for "usfda"

FDA Approves UCB's Vimpat as Monotherapy


Strides Arcolab has secured the approval from the US Food and Drug Administration for marketing Buspirone Hydrochloride tablets in US. The approval is for tablets in strengths of 5 milligrams (mg), 10 mg 15 mg and 30 mg. The company will ... 4 Traders, 13 hours ago
FDA Approves UCB's Vimpat as Monotherapy PharmaAsia, 22 hours ago

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Financial Express, 1 day ago, 2 days ago, 1 week ago
Business Standard, 1 day ago
Financial Express, 2 days ago
Business Standard, 2 days ago
Business Standard, 4 days ago, 1 week ago
Business Standard India, 1 week ago
Business Standard India, 1 week ago
Business Standard

Will take 2-2.5 yrs for phase-3 clinical trails: Wockhardt

The QIDP status will allow fast tracking of the drug application from the USFDA and 5-year extension for the drug patents in the US.
 Money Control1 day ago Wockhardt gains after USFDA agrees to fast track approval for two novel drugs  Hindu Business Line1 day ago Wockhardt drug discovery fast track nod by USFDA  Press Trust of India1 day ago Wockhardt drug discovery gets fast track approval from USFDA  Business Standard2 days ago

Natco Pharma gains 5%; hits 52-week high

company announced that its marketing partner in the USA, Mylan Inc has filed ANDA and has been accepted by USFDA SI Reporter | Mumbai September 1, 2014 Last Updated at 13:25 IST Natco Pharma has gained 5% to Rs 1267 also its 52-week high on the BSE after the ...
 Business Standard1 day ago Indoco Remedies spurts 14% after USFDA approves Goa plants  Myiris1 month ago Indoco Remedies rallies 20%, hits 52-week high after USFDA approves plants  Economic Times1 month ago Indoco Remedies up 20% as USFDA approves plants  Economic Times1 month ago
Business Standard

Wockhardt gains 5% post USFDA fast-tracks nod for anti-infection drugs

The company has received QIDP status from the USFDA for two of its drugs, WCK 771 and WCK 2349. SI Reporter | Mumbai September 1, 2014 Last Updated at 09:23 IST Wockhdardt has rallied 5% to Rs 724 after the pharmaceutical company has received Qualified ...
 Business Standard1 day ago
Business Standard

Natco gets USFDA acceptance for generic Copaxone

BS ReporterHyderabad, 30 Aug:Hyderabad-based Natco Pharma Limited stated that its marketing partner in the US, Mylan Inc, has filed an abbreviated new drug application (ANDA) for a three-times-a-week generic Copaxone (glatiramer acetate injection, ...
 Business Standard3 days ago Natco gets USFDA approval for generic Copaxone  INooz3 days ago
International Business Times India

USFDA Issues Warning to Indian Drug Maker Marck Biosciences

FDA investigators identified significant violations of cGMP regulations for finished pharmaceuticals during inspections from 29 October to 1 November 2013 at the Kheda, India manufacturing facility of Marck Biosciences, according to an FDA warning ...
 PharmaAsia6 days ago USFDA issues warns Marck Biosciences for GMP violation  Business Standard1 week ago USFDA issues warning to Marck Biosciences  Economic Times1 week ago USFDA to add Personnel in India to Boost Inspection  International Business Times India3 weeks ago
Business Standard


Marck Biosciences of Gujarat has received a warning letter from the US Food and Drug Administration (USFDA) on its plant at Kheda in Gujarat for alleged violations of current good manufacturing practice (CGMP) regulations for ...
 Pharmaceutical & Medical Packaging News1 week ago Marck Bio "surprised" at USFDA warning over Gujarat plant  Hindu Business Line1 week ago

Expect double-digit growth in FY15: Nectar Life

Dinesh Dua CEO Nectar Lifesciences S The company is hoping to get USFDA approval for its formulations plant in Baddi. Of late, Nectar is focussing on changing revenue mix to formulation instead of APIs. Below is the transcript of Dinesh Dua's ...
 Moneycontrol.com1 week ago Promoters not looking to offload stake: Nectar Lifesciences  Money Control2 months ago

Marck Biosciences plans to re-apply for FDA certification within next one yr

It received warning letter from USFDA for alleged violations of CGMP for finished pharmaceuticals BS Reporter | Ahmedabad August 22, 2014 Last Updated at 16:15 IST Ahmedabad-based Marck Biosciences plans to appoint an external consultant to sort out ...
 Business Standard India1 week ago

Cadila Healthcare jumps after USFDA OK for anti-viral drug

Cadila Healthcare rose 3.67% to Rs 1,235.70 at 12:50 IST on BSE after the company said Zydus Cadila has received the final approval from the US drug regulator to sell anti-viral drug in multiple strengths in the US market. The company made the ...
 Capital Market1 week ago
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