Feb 23, 2015 at 15:17 | Source: Reuters
The FDA inspected the plant in January this year, after which it issued the company a so-called Form 483, listing six observations on the manufacturing processes at the plant, Lupin said in a statement, without giving details.
Feb 06, 2015 at 22:06 | Source: Moneycontrol.com
SMS Pharmaceuticals in its meeting held on February 06, 2015, has considered the items the Board appointed an Independent Committee to explore the possibilities of Demerger of Non-FDA Manufacturing Units of the Company and submit a detailed report to the Board for consideration.
Feb 05, 2015 at 12:09 | Source: Moneycontrol.com
The brokerage had a cautious view on the stock for past year, awaiting better visibility by regulatory issues and future approvals but Form 483 issued by the US FDA in early 2014 on the Morton Grove US facility has now been resolved, which provides significant comfort around the sustainability of the remaining US business.
Jan 27, 2015 at 13:17 | Source: PTI
Drug major Ranbaxy today said that the US health regulator has "determined" that the Indian drug manufacturer has forfeited its 180 days exclusivity for stomach and esophagus problems treatment tablets.
Jan 25, 2015 at 16:54 | Source: PTI
Drug major Sun Pharma's top executive Dilip S Shanghvi expects the USD 4-billion Ranbaxy deal to be concluded by middle of next month while stating that the key challenge before the combined entity would be to rebuild the confidence of health regulators.
Jan 23, 2015 at 10:38 | Source: Reuters
Ipca had voluntarily halted shipments to the United States from the plant in July last year after the FDA outlined half a dozen violations including data integrity issues.The FDA announced the ban, called import alert, in a notice on its website late on Thursday. It did not elaborate
Jan 07, 2015 at 15:54 | Source: Firstpost.com
Narendra Modi is taking a leaf out of Vajpayees book, only this time it is a whole branch, and not just a leaf. Rs 2,00,000-3,00,000 crore is one helluva public investment stimulus. It would range from 1.4-2.1 percent of potential GDP in 2015-16.
Jan 06, 2015 at 11:09 | Source: Moneycontrol.com
"Jubilant received abbreviated new drug application (ANDA) final approval from the US Food and Drug Administration (US FDA) for Mycophenolate Mofetil USP and Rizatriptan," said the pharmaceuticals and life sciences company in its filing to the exchange.
Jan 05, 2015 at 13:51 | Source: CNBC-TV18
Revenue growth for the global pharmaceutical company stands at 15 percent for FY15 and 25 percent for FY16. Going ahead, the company awaits FDA approval for their new plant, C Krishna Prasad adds.
Dec 19, 2014 at 15:58 | Source: PTI
The collaboration has been established for an oral controlled release product utilising Panacea's platform of oral drug delivery technology, Panacea Biotec Ltd said in a statement.