Aurobindo Pharma climbs after USFDA nod for OTC drug
Shares of Aurobindo Pharma surged over 2 percent today after the firm got final approval from USFDA to manufacture and market its generic Naproxen Sodium tablets used for treatment of osteoporosis.
Mar 21, 2016, 10:33 AM IST
Aurobindo Pharma gets USFDA nod for osteoporosis drug
Aurobindo Pharma has received final nod from the US health regulator to manufacture and market its generic Naproxen Sodium tablets used for the treatment of osteoporosis in postmenopausal wome
Mar 19, 2016, 15:22 PM IST
Lupin receives nine observations from USFDA for Goa plant
Drug major Lupin on Tuesday says that it has received nine observations relating to inadequacy and adherence to operating norms for its manufacturing plant in Goa from the US Food and Drug Administration (USFDA)
Mar 15, 2016, 18:09 PM IST
Glenmark gets USFDA final nod for anti-bacterial drug
Glenmark Pharmaceuticals has received the final nod from the US health regulator for a generic version of anti-bacterial drug Zyvox.
Dec 22, 2015, 13:02 PM IST
Sun Pharma shares slump 7.5% on warning letter from USFDA
Shares of Sun Pharmaceutical slumped 7.5 percent Monday as the company has received a warning letter from the USFDA over violation of manufacturing norms at its facility at Halol in Gujarat.
Dec 21, 2015, 14:03 PM IST
Sun Pharma gets warning letter from USFDA over Halol unit
Drug major Sun Pharmaceutical Industries on Saturday said it has received a warning letter from the USFDA over violation of manufacturing norms in its facility at Halol in Gujarat.
Dec 19, 2015, 14:37 PM IST
Aurobindo gets USFDA nod to market generic Osteoporosis drug
Aurobindo Pharma today said it has received final approval from USFDA to manufacture and market generic version of Risedronate Sodium tablets, used in the treatment of Osteoporosis, in the American market.
Dec 01, 2015, 20:42 PM IST
Jubilant Life zooms 10% as firm gets USFDA nod for drug
Jubilant Life Sciences shares soared almost 10 per cent, to touch its 52-week high level today, as the company received final approval from the US health regulator for its generic version of anti-depressant Paxil tablets.
Dec 01, 2015, 15:02 PM IST
USFDA gives Dr Reddy's addl time to respond to warning letter
Dr Reddy's Laboratories Ltd (DRL) Thursday said the USFDA has extended the time-frame for replying to the warning letter issued to the company by about two weeks to December 7.
Nov 26, 2015, 18:38 PM IST
Dr Reddy's shares slump 8.5%; m-cap dips Rs 4,746 crore
The stock fell on reports that the US Food and Drug Administration (USFDA) might withhold approval of the company's fresh drugs and stop import after it found several violations at three of its plants.
Nov 26, 2015, 18:28 PM IST
US FDA warns of DRL drug import ban if flaws are not fixed
The US Food and Drug Administration (US FDA), which had issued a warning letter to Dr Reddy's Laboratories over quality issues, has said it might withhold approval of the company's fresh drugs and stop import if no corrective action is taken.
Nov 25, 2015, 18:34 PM IST
US court asks Dr Reddy's Laboratories to halt generic sale of esomeprazole
A US court has directed Dr Reddy's Laboratories to temporarily stop selling its generic version of esomeprazole in the US market.
Nov 10, 2015, 17:41 PM IST
Dr Reddy's tanks 14.5 pc on USFDA warning
Shares of drug firm Dr Reddy's Laboratories today plunged 14.5 per cent after the company said it has received a warning letter from the US health regulator over inadequate quality control procedures at its three drug manufacturing units in India.
Nov 06, 2015, 13:02 PM IST
Novartis gets USFDA warning letter for two plants in India
Sandoz, the generic drug arm of Swiss drug major Novartis, has received a warning letter from the US health regulator for violations of current good manufacturing practice (cGMP) norms at its two plants in Western India.
Oct 28, 2015, 21:05 PM IST
Aurobindo may launch Tramadol tablets in US market
Aurobindo Pharma has rreceived final approval from the US Food and Drug Administration to launch Tramadol Hydrochloride extended-release tablets in the US maket.
Oct 23, 2015, 13:28 PM IST
Cipla's Indore plant under USFDA scanner over norms violations
Pharmaceutical major Cipla's shares dropped by 2.13 percent Tuesday amid speculation that the company's Indore plant has come under the scanner of US health regulator for manufacturing norms violations.
Oct 20, 2015, 18:31 PM IST
Sun Pharma withdraws suit filed by Ranbaxy against USFDA
The lawsuit challenged FDA's revocation of Ranbaxy's tentative approvals for its generic versions of Nexium and Valcyte in the US.
Oct 09, 2015, 14:54 PM IST
Sun, Wockhardt recall drugs from US market
Sun Pharma and Wockhardt have separately initiated voluntary recall of a number of drugs from the US market due to different reasons.
Aug 30, 2015, 13:28 PM IST
Maggi ban: FSSAI reviewing court's order, yet to decide on future course
The Bombay High Court had on August 13 quashed the orders of FSSAI and Maharashtra FDA banning nine variants of Maggi noodles in the country.
Aug 18, 2015, 15:51 PM IST
No ''Maggi'' hearing at apex consumer court on Friday
Hearing on the the Rs.640-crore class action suit filed by the Indian government against Nestle India, alleging unfair trade practices with regard to Maggi noodles was not heard at the apex consumer disputes forum on Friday.
Aug 14, 2015, 13:03 PM IST
