USFDA

Zydus unit gets 10 observations from USFDA after inspection

The US Food and Drug Administration (USFDA) inspected the facility at Jarod near Vadodara from April 15 to April 23, the drug maker said in a regulatory filing.

24 April 2024, 08:00 IST

Zydus unit gets 10 observations from USFDA after inspection

24 April 2024, 08:00 IST

Sun Pharma, Lupin recall drugs in US market over manufacturing issue

Mumbai-based Sun Pharmaceutical Industries is recalling 96,192 bottles of Liothyronine Sodium Tablets in the US that are used to treat an underactive thyroid, according to the latest enforcement report issued by the American health regulator.

17 December 2023, 05:23 IST

Sun Pharma, Lupin recall drugs in US market over manufacturing issue

17 December 2023, 05:23 IST

USFDA issues Form 483 with 5 procedural observations to Torrent Pharma's Gujarat unit

The USFDA conducted a pre-approval Inspection at the company's oral manufacturing facility situated in Bileshwarpura, Gujarat from December 5 to 11, 2023, Torrent Pharma said in a regulatory filing.

12 December 2023, 07:50 IST

USFDA issues Form 483 with 5 procedural observations to Torrent Pharma's Gujarat unit

12 December 2023, 07:50 IST

Indian goods worth $3.7 bn entering Oman to get boost by free trade agreement: GTRI

India and Oman are negotiating a comprehensive economic partnership agreement (CEPA), under which the two countries could significantly reduce or eliminate customs duties on the maximum number of goods agreed between them.

12 December 2023, 07:30 IST

Indian goods worth $3.7 bn entering Oman to get boost by free trade agreement: GTRI

12 December 2023, 07:30 IST

Milestone pig-to-human heart transplant may pave the way for broader trial

In the past couple of years, pig xenotransplants have been tested in both nonhuman primates and deceased humans—but the ultimate goal is to conduct human clinical trials on a bigger scale.

18 October 2023, 16:54 IST

Milestone pig-to-human heart transplant may pave the way for broader trial

18 October 2023, 16:54 IST

Sun Pharma files new drug application with USFDA for investigational medicine to treat alopecia

In the new drug application, Sun Pharma has submitted the 8mg twice daily regimen of deuruxolitinib for US Food and Drug Administration (USFDA) review, the company said in a statement.

06 October 2023, 08:52 IST

Sun Pharma files new drug application with USFDA for investigational medicine to treat alopecia

06 October 2023, 08:52 IST

US FDA issues warning letters to three baby formula manufacturers

The regulator issued these letters to ByHeart Inc, Reckitt Benckiser Group's Mead Johnson Nutrition and Perrigo's Wisconsin unit.

30 August 2023, 20:54 IST

US FDA issues warning letters to three baby formula manufacturers

30 August 2023, 20:54 IST

Alembic, Aurobindo recall drugs in US market

The company initiated the Class II nationwide (US) recall on July 21 this year.

21 August 2023, 12:30 IST

Alembic, Aurobindo recall drugs in US market

21 August 2023, 12:30 IST

Major US health systems expect to offer Alzheimer's drug Leqembi in a few months

Leqembi, which won full US regulatory approval last month, is the first treatment proven to slow progression of the mind-robbing disease for people in the earliest stages of Alzheimer's.

07 August 2023, 10:32 IST

Major US health systems expect to offer Alzheimer's drug Leqembi in a few months

07 August 2023, 10:32 IST

USFDA issues warning letter to Intas Pharma for Sanand plant

A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.

06 August 2023, 09:41 IST

USFDA issues warning letter to Intas Pharma for Sanand plant

06 August 2023, 09:41 IST