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About 963 results for "usfda"

Strides Arcolab gets import alert from USFDA
Business Standard

Strides Arcolab gets import alert from USFDA

Company says the product is not meant for the US market and it has approval to supply to a customer only in Africa BS Reporter | Bangalore October 2, 2014 Last Updated at 00:17 IST Strides Arcolab, a Bangalore-based mid-size publicly-held pharmaceutical ... Business Standard, 23 hours ago
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97 images for usfda

Livemint.com, 1 day ago
Financial Express, 1 week ago
India TV, 1 week ago
Business Today India, 1 week ago
Business Standard India, 20 hours ago
Sify, 1 day ago
Namibian Sun, 1 week ago
Sify, 3 days ago
Livemint.com, 1 week ago
Business Standard, 6 days ago
Livemint.com

Strides working with USFDA on import alert on unit's products

Strides Arcolab also clarified that it has no role in the distribution of any of the mentioned products in the US territory. New Delhi: Drug firm Strides Arcolab Ltd on Wednesday said it is working with the US health regulator to ascertain how ...
 Livemint.com1 day ago Strides Arcolab working with USFDA on import alert on unit's products  Economic Times1 day ago USFDA warning shaved off $100M from Mylan's deal to buy Agila...  VC Circle5 days ago Strides in trouble over Africa drugs  Deccan Chronicle21 hours ago
Business Standard

Sun Pharma up 4% on likely USFDA relief

MUMBAI: The Sun Pharma scrip gained by over 4% on Friday amid reports that chances of an ban imposed by US regulator on its key Halol (Gujarat) plant were "low". The scrip closed with a gain of 4% at Rs 807 on the BSE on Friday. A team of USFDA ...
 Times of India5 days ago No USFDA import alert on Sun's Halol plant, shares up 6%  Business Standard6 days ago USFDA continues to audit Sun Pharma's Halol plant  Money Control1 week ago Pharma metal drag Sensex, Nifty; SBI, HUL top gainers  Money Control3 weeks ago
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Sun Pharmaceutical Industries shares up over 4 per cent on bourses

MUMBAI: Shares of rose by over 4 per cent today amid reports that the company is unlikely to be adversely affected by USFDA notifying objectionable conditions at its Gujarat plant. The pharma firm's stock ended 4.30 per cent higher at Rs 807.10 on ...
 Economic Times6 days ago Sun Pharma shares up over 4% on bourses  Business Standard6 days ago

Sun Pharma's troubles with USFDA procedural: Credit Suisse

Sun Pharmaceutical Industries plant in Halol, Gujarat, has received 23 regulatory observations from the US Food and Drug Administration, a Credit Suisse report said. But with the observations being related to procedural issues rather than data ...
 Hindu Business Line6 days ago Sun Pharma slips, USFDA scrutiny likely warns Credit Suisse  Money Control2 months ago
Moneycontrol.com

USFDA bans two Indian plants on GMP violations

The USFDA has served import alerts to Canadian drug company Apotex Research’s manufacturing facility in Bangalore and Indian firm Micro Labs manufacturing unit in Goa. For both the drug companies, this is their second Indian facility being banned by USFDA.
 Money Control6 days ago Canada bans import of select products made by Ipca Labs  The Freepress Journal13 hours ago Health Canada issues import ban on Apotex Pharma, IPCA  Hindu Business Line1 day ago Health Canada asks Ipca to stop ingredients shipment  Hindu Business Line1 week ago
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USFDA recognizes Natco Pharma's Kothur Formulation Facility as acceptable

Natco Pharma's Kothur Formulation facility has been found acceptable by United States Food and Drug Administrator (USFDA). The company has received a letter dated July 14, 2014 after completing review of the Establishment Inspection Report (EIR) for ...
 Indian-Commodity2 weeks ago Kothur formulation facility acceptable to USFDA, says Natco  Myiris2 weeks ago Natco's Formulation Facility at Kothur found acceptable by USFDA  Equity Bulls1 week ago Natco's Kothur formulation facility found acceptable by USFDA  Money Control2 weeks ago
Business Standard

USFDA to start inspection at Aurobindo's H'bad unit on Sat

In Q1 conference call, the management had mentioned that unit 4, 3 as well as 7 should see some USFDA audits considering that they were due for inspection.
 Money Control1 week ago Sun, Ranbaxy fall on surprise inspection by USFDA  Times of India2 weeks ago USFDA may extend audit at Sun Pharma's Halol facility  Money Control2 weeks ago Sun Pharma falls 6% as USFDA inspects Halol unit; facility contributes 40% of US sales  Economic Times3 weeks ago
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Business Standard

Wockhardt's 2 drugs receive USFDA's QIDP status

QIDP status allows for fast track review of the drug application by USFDA paving way for an early launch fast-tracks approval for Wockhardt drugs BS B2B Bureau | Mumbai September 3, 2014 Last Updated at 12:15 IST The US Food and Drug Administration (USFDA) ...
 Business Standard4 weeks ago Will take 2-2.5 yrs for phase-3 clinical trails: Wockhardt  Money Control1 month ago Wockhardt gains after USFDA agrees to fast track approval for two novel drugs  Hindu Business Line1 month ago Wockhardt drug discovery fast track nod by USFDA  Press Trust of India1 month ago
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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 ...
 PharmaAsia1 month ago USFDA issues warns Marck Biosciences for GMP violation  Business Standard1 month ago USFDA issues warning to Marck Biosciences  Economic Times1 month ago Indian drug regulator plugs quality gaps after drawing flak from USFDA  Hindu Business Line1 month ago
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