Aug 26, 2016 at 13:48 | Source: PTI
The tentative approval by the United States Food and Drug Administration (USFDA) is for multiple strengths of 12.5 mg, 25 mg and 37.5 mg of the generic version of Apotex Technologies' Paxil CR tablets of similar strengths, Lupin said in a BSE filing.
Aug 26, 2016 at 13:10 | Source: Moneycontrol.com
Lupin has received tentative approval for its Paroxetine Extended-Release Tablets USP, 12.5 mg, 25 mg and 37.5 mg from the United States Food and Drug Administration (FDA) to market a generic version of Apotex Technologies, Inc.s Paxil CR Tablets, 12.5 mg, 25 mg and 37.5 mg.
Oct 13, 2015 at 20:38 | Source: PTI
The voluntary Class III ongoing recall for the extended-release tablets has been initiated as "one lot of product did not meet the first stage dissolution specification limits", USFDA said in the Enforcement Report for the week of October 7, 2015.
Dec 03, 2014 at 13:24 | Source: Moneycontrol.com
Meda Pharmaceuticals Inc. and Cipla sued Apotex Inc. and Apotex Corp. in Federal District Court in Delaware to enforce the Orange-Book listed patents covering Dymista Nasal Spray in response to Apotex's submission to the USFDA of an ANDA.
Nov 07, 2014 at 10:04 | Source: Moneycontrol.com
Brokerages are worried about the stocks and stress that approval of Sun Pharma-Ranbaxy deal will be key driver. They feel that this negative surprise may benefit Dr Reddy's.
Oct 01, 2014 at 16:56 | Source: PTI
The Canadian regulator said IPCA has not disputed the FDA findings with Health Canada even as the FDA has not issued a recall of any of the affected products.
Sep 26, 2014 at 21:28 | Source: CNBC-TV18
The USFDA has served import alerts to Canadian drug company Apotex Researchs 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.
Apr 03, 2014 at 14:46 | Source: Reuters
Drugs made at the plant, based in Bangalore, will be detained without physical examination because the factory did not meet the FDA's good manufacturing practices, the agency said on its website on Wednesday.
May 21, 2010 at 13:19 | Source: Reuters
Ranbaxy Laboratories, India's largest drugmaker by sales, has launched a generic version of Pfizer's cholesterol-lowering drug Lipitor in Canada, the company said on Friday.
May 20, 2010 at 15:24 | Source: Reuters
Generic forms of Pfizer Inc's blockbuster Lipitor cholesterol fighter began flooding into Canada on Wednesday, in a taste of what is to come for the USD 12 billion-a-year drug next year in the United States