Page 6 of USFDA

Aurobindo Pharma gets USFDA nod for generic Tranexamic acid injection

Aurobindo Pharma has received final approval from the USFDA to manufacture and market its Tranexamic acid injection, used for treating…

January 17, 2016 01:49 IST

USFDA makes 9 observations over Wockhardt’s plant in Aurangabad

The USFDA has made nine ‘observations’ highlighting violations of its norms at homegrown drug maker Wockhardt’s new facility at Shendra…

January 15, 2016 18:22 IST

Cadila Healthcare receives warning letter from US FDA

The letters were received for its two facilities in Gujarat Cadila Healthcare has received a warning letter from the US…

December 31, 2015 12:29 IST

India, China in focus: US lawmakers write to GAO over fake drug concern

Questions USFDA’s progress in meeting demands

December 28, 2015 07:03 IST

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Dr Reddy’s submits response to USFDA over warning letter

Last month, the country’s second-largest drug maker, Dr Reddy’s, had received a warning letter from the USFDA relating to two…

December 9, 2015 09:24 IST

USFDA gives Dr Reddy’s additional time to respond to warning letter

Dr Reddy’s Laboratories Ltd (DRL) today said the USFDA has extended the time-frame for replying to the warning letter issued…

November 26, 2015 17:49 IST

Sun Pharma withdraws suit filed by Ranbaxy against USFDA

Drug major Sun Pharmaceutical has withdrawn its appeal in the lawsuit filed by Ranbaxy against the US health regulator challenging…

October 9, 2015 13:53 IST

Over 100 stocks hit fresh 52-week high in today's trade

Jubilant Life Sciences shares gain on receiving USFDA approval for Indomethacin ER Capsule

Jubilant Life Sciences shares gained as much as 3.5 per cent intraday on Wednesday after the company informed BSE that…

Updated: October 7, 2015 16:26 IST

US FDA approves Bionomics’ cancer drug

The drug targets hard-to-treat colorectal and pancreatic cancers, but may also prove suitable to treat breast, lung and other tumours…

September 25, 2015 10:10 IST

USFDA issues warning to Pan Drugs for GMP violations

US health regulator has issued a warning to Gujarat-based Pan Drugs over “significant deviations” from good manufacturing norms at its…

September 16, 2015 21:38 IST

Glenmark Pharmaceuticals gets USFDA nod for fungal infections treatment drug

Glenmark Pharmaceuticals today said it has received final approval from the US health regulator for Voriconazole Tablets, used to treat…

September 4, 2015 11:59 IST

Aurobindo Pharma shares gain over 3% on key drug approvals

Aurobindo Pharma shares over 3 per cent in the early trade on Monday on BSE after the company on August…

Updated: August 31, 2015 15:52 IST

Dr Reddy’s Laboratories recalls anti-seizure, hypertension drugs from US market

Dr Reddy’s Laboratories has started recalling Divalproex Sodium extended-release tablets as it has failed dissolution tests, and Amlodipine Besylate and…

June 29, 2015 15:09 IST

US FDA warns over 1,000 illegal online medicine sellers

Also seizes illegal drugs and medical devices sold through these websites

June 19, 2015 16:35 IST

Aurobindo Pharma receives USFDA approval for Metronidazole tablets

Metronidazole tablets are used to treat different types of infections

June 2, 2015 12:10 IST

Strides Arcolab receives ANDA approval from US FDA

Product to be launched immediately Strides Arcolab has received approval from the United States Food & Drug Administration (USFDA) for…

May 15, 2015 17:23 IST

US FDA, DCG(I) explore more ways to work together

Willing to collaborate with Indian regulators, other stakeholders: US FDA

April 5, 2015 08:30 IST

End of Wockhardt’s Chikalthana USFDA woes?

No major findings from recent USFDA inspection, after 2013 import alert on the company’s Aurangabad-based Waluj and Chikalthana facilities

April 5, 2015 08:20 IST

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