Glenmark Pharma gets US FDA tentative ANDA approval for rufinamide tablets USP

New Delhi, May 21, 2015 Glenmark Pharmaceuticals Inc., USA (Glenmark) has received tentative approval from US FDA for its rufinamide…

Dr Reddy’s files new drug application with USFDA

Hyderabad, April 13, 2015 Dr Reddy’s Laboratories and its subsidiary, Promius Pharma today announced filing of three new drug applications…

• US FDA Approval

FDA concludes Arctic Apples and Innate Potatoes are safe for consumption

New Delhi, Mar 25, 2015 – The U.S. Food and Drug Administration completed its evaluation for two varieties of apples…

FDA recalls from US shelves 200 vials of chemotherapy drug produced by Sun Pharmaceuticals

Washington, 24 Mar, 2015: India’s pharmaceutical woes continue, as the US Food and Drug Administration (FDA) announced this week that it…

Ranbaxy sues the US FDA for revoking two key drug approvals

Washington, 24 Mar, 2015: The Indian drug manufacturer Ranbaxy, based in Haryana, has sued the US Food & Drug Administration (US…

USFDA auditors inspect Shilpa Medicare facilities

Bengaluru, Mar 12, 2015 USFDA auditors have inspected Shilpa Medicare Ltd’s manufacturing facilities located at Deosugur Industrial Area, Deosugur, Raichur…

Lupin to sell generic HIV drug

New Delhi, Jan 05, 2015 Lupin Ltd announced that it has received a tentative approval from the US Food and…

Issuance of Form 483 by US FDA to IPCA Laboratories not the First Time

New Delhi, Dec 31, 2014:  Recently on 19 December 2014, The Silvasa facility of IPCA Laboratories received Form 483 having…

Renewal of Food, Beverage, Drug, and Medical Device Facilities with US FDA until December 31, 2014

New Delhi, Dec 31, 2014: The facilities which produce FDA regulated drugs require to register with US FDA and renew their…

Nine Observations given to Dr Reddy’s Laboratory at Srikakulam Plant by USFDA

New Delhi, Dec 31, 2014: US FDA recently visited Dr Reddy’s Laboratories manufacturing facility at Srikakulam district which is the bulk…