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.

Sun Pharma shares slump 7.5% on warning letter from USFDA

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.

Sun Pharma gets warning letter from USFDA over Halol unit

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.

Aurobindo gets USFDA nod to market generic Osteoporosis drug

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.

Jubilant Life zooms 10% as firm gets USFDA nod for drug

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.

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.

Dr Reddy's shares slump 8.5%; m-cap dips Rs 4,746 crore

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.

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.

US court asks Dr Reddy's Laboratories to halt generic sale of esomeprazole

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.

Dr Reddy's tanks 14.5 pc on USFDA warning

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.

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.

Aurobindo may launch Tramadol tablets in US market

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.

Cipla's Indore plant under USFDA scanner over norms violations

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.

Sun Pharma withdraws suit filed by Ranbaxy against USFDA

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.

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.

'US nod to Lupin's anti-cholesterol drug may not fatten up firm financials'

Lupin Ltd's anti-cholesterol drug securing USFDA approval is a positive development but may not contribute to the company's financials in a major way.

Maggi ban: FSSAI reviewing court's order, yet to decide on future course

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.

FDA approves use of OxyContin in children between 11-16 years

The US Food and Drug Administration has approved limited use of powerful painkiller OxyContin for children as young as 11 years old.

No ''Maggi'' hearing at apex consumer court on Friday

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.

Timeline of Maggi noodles' ban

Here is the timeline of the chain of events.