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About 905 results for "usfda"

SPARC Surges Over 8% on USFDA Nod for Epilepsy Drug
NDTV Profit

SPARC jumps on USFDA nod for new drug application

iracetam extended-release tablets 1000 mg and 1500 mg). Elepsia XR is indicated for adjunctive therapy in the treatment of partial onset seizures in patients 12 years of age and older with epilepsy. "Levetiracetam is a very successful and highly effective ... Business Standard, 23 hours ago
SPARC gets USFDA nod for its anti-epileptic drug ELEPSIA XR Business Standard India, 23 hours ago

36 images for usfda

NDTV Profit, 1 day ago
Money Control, 2 days ago
India Infoline, 3 hours ago
NDTV Profit, 19 hours ago
Business Standard, 23 hours ago
Business Standard, 1 day ago, 1 day ago
NDTV Profit, 2 days ago
Business Standard, 2 days ago
DNA, 1 week ago

Ranbaxy loses appeal on approvals, exclusivity of 2 drugs in US

In November, Ranbaxy had sued USFDA over revoking an approval to sell generic versions of Nexium and Valcyte in the US. Photo: Pradeep Gaur/Mint New Delhi: Ranbaxy Laboratories tentative approvals for its generic versions of digestive disorder ...
 Livemint.com1 day ago Ranbaxy loses approvals of 2 drugs in U.S.  The Hindu1 day ago Ranbaxy loses approvals, exclusivity of 2 drugs in US  DNA1 day ago Ranbaxy loses exclusivity as USFDA allows Teva to launch Nexium generic  PharmaBiz1 month ago
Business Today India

BUZZ-India's Sun Pharma surges to record high on hopes of USFDA relief for key unit

11:17am IST ** Sun Pharmaceutical Industries gains 5.9 pct to record high of 998.70 rupees ** Heads towards its biggest daily gain since April 2014 ** Stock gained about 15 pct in four straight sessions of gains till Wednesday vs NSE ...
 Reuters India1 day ago Sun Pharma shares rise 5.9 per cent to record high  Business Today India22 hours ago

USFDA flags concerns over Lupin's plant

MUMBAI: Lupin said on Monday that the US Food and Drug Administration (FDA) has raised concerns over manufacturing processes at the company's Pithampur plant. The USFDA inspected the plant in January this year, after which it issued the company ...
 Times of India1 week ago USFDA expresses concern over conformity norms of Lupin's Indore unit  Hindu Business Line1 week ago USFDA raises concerns over Lupin's Indore plant  Business Standard1 week ago Lupin : USFDA RAISES CONCERNS OVER LUPIN's INDORE UNIT  4 Traders1 week ago
Money Today

Wockhardt Ltd clarifies on USFDA concern over Waluj plant

Posted On: 2015-02-27 10:49:18 The Exchange had sought clarification from Wockhardt Ltd with respect to news appearing in Financial Chronicle on February 27, 2015 titled "USFDA raises concern over Wockhardt's plant." Wockhardt Ltd has replied ...
 Equity Bulls5 days ago Addressing USFDA concerns over Waluj unit, says Wockhardt  Business Standard6 days ago USFDA raises fresh concerns about Wockhardt's Waluj plant  Money Today6 days ago No grave observations made in USFDA Waluj visit: Wockhardt  Money Control1 week ago

Wockhardt slides over 5% over USFDA checklist

MUMBAI: Wockhardt saw sharp selling pressure after the USFDA's observations at its Waluj facility. According to reports, the USFDA made seven observations, some of which are serious in nature. At least one observation is a repeat of 2013 ...
 Economic Times1 week ago
Business Standard

Should investors buy Ipca Labs after US import alert?

MUMBAI: Shares of Ipca Laboratories have been badly hit after the company finally received import alert from the USFDA for its Ratlam plant. It is the only USFDA approved API plant. Hence, the revenues from the US are expected to get impacted ...
 Economic Times1 month ago Ipca Labs: Under pressure after USFDA ban on Ratlam plant  Smart Investor1 month ago IPCA Labs receives USFDA's import alert for MP plant  Business Standard1 month ago Ipca Labs hit by USFDA ban on plant for standard violations of production practices  Economic Times1 month ago

Natco Pharma files for approval of multiple sclerosis, cancer drugs from USFDA

Natco Pharma Ltd has filed Abbreviated New Drug Applications (ANDAs) for fingolimod capsules and cabazitaxel injection with the US Federal Drug Administration (USFDA). The filing was done through its respective marketing partners in the US, the ...
 Hindu Business Line3 weeks ago Natco Seeks USFDA Nod for New Drugs  New Indian Express3 weeks ago Natco Pharma up 5% on filing new drug applications with USFDA  Business Standard3 weeks ago Natco Pharma gains 4.5% after filing new drug applications with USFDA  First Post.com3 weeks ago

Natco Pharma files for Sorafenib tablets with USFDA

announced today that its marketing partner, Mylan, has filed an Abbreviated New Drug Application (ANDA) for Sorafenib tablets, 200mg, with the US Federal Drug Administration (USFDA). This product is the generic version of NEXAVAR, which is indicated for the ...
 Myiris3 weeks ago Natco Pharma gains after filing 2 ANDAs with USFDA  Myiris3 weeks ago Natco Pharma announces USFDA Filing for Sorafenib Tablets, 200mg  HDFC Securities3 weeks ago Natco Pharam files ANDAs for USFDA approval  Capital Market3 weeks ago
India Infoline

STRIDES ARCOLAB : Usfda finds strides' bangalore unit fit

The US Food and Drug Administration (FDA) has found the oral dosage manufacturing unit of Strides Arcolab in Bangalore to be acceptable after an inspection. The US FDA had inspected the KRS Gardens facility in Aug 2014 .
 4 Traders1 month ago Strides Arcolab gets USFDA approval for Oral Dosage Facility  Capital Market1 month ago Strides Arcolab gains on USFDA OKs oral dosage facility at Bangalore  Smart Investor1 month ago Strides gets continued USFDA nod for Bangalore facility  India Infoline1 month ago
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