USFDA

Dr Reddy's, FDC recall products in US for manufacturing issues

As per the latest Enforcement Report by Food and Drug Administration (USFDA), the US-based subsidiary of Dr Reddy's Laboratories is recalling multiple strengths of Morphine Sulfate extended-release tablets in the US.

17 November 2024, 07:19 IST

Dr Reddy's, FDC recall products in US for manufacturing issues

17 November 2024, 07:19 IST

Cipla gets 8 observations from USFDA for Bengaluru facility

The US Food and Drugs Administration (USFDA) conducted an inspection at the company's manufacturing facility in Virgonagar, Bengaluru from November 7- 13.

13 November 2024, 20:00 IST

Cipla gets 8 observations from USFDA for Bengaluru facility

13 November 2024, 20:00 IST

Dr Reddy's recalls over 3.3 lakh bottles of generic medication in US: USFDA

According to the latest Enforcement Report by the US Food and Drug Administration, Dr Reddy's is recalling the 3,31,590 bottles of Cinacalcet tablets in multiple strengths in the American market due to CGMP (current good manufacturing practice) deviations.

03 November 2024, 11:56 IST

Dr Reddy's recalls over 3.3 lakh bottles of generic medication in US: USFDA

03 November 2024, 11:56 IST

Alembic Pharma gets USFDA nod for generic product

Albendazole tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium.

05 September 2024, 12:57 IST

Alembic Pharma gets USFDA nod for generic product

05 September 2024, 12:57 IST

USFDA pulls up Eugia for manufacturing lapses, data accuracy at Hyderabad plant

In a warning letter to Eugia Pharma Specialities CEO Yugandhar Puvvala, the US health regulator pointed out that the company failed to ensure the accuracy of data for production and process simulation.

25 August 2024, 09:53 IST

USFDA pulls up Eugia for manufacturing lapses, data accuracy at Hyderabad plant

25 August 2024, 09:53 IST

Dr Reddy's gets establishment inspection report from USFDA for Visakhapatnam units

The USFDA has classified the company's formulations manufacturing facilities (FTO-7 & FTO-9) in Duvvada, as Voluntary Action Indicated (VAI) and concluded that the inspection is "closed", Dr Reddy's Laboratories Ltd said in a regulatory filing.

12 August 2024, 06:22 IST

Dr Reddy's gets establishment inspection report from USFDA for Visakhapatnam units

12 August 2024, 06:22 IST

US FDA rejects use of psychedelic MDMA for PTSD patients

The closely held company is pushing back on the agency’s request, saying it would take an inordinate amount of time to complete the work. It plans to request a meeting with the agency to ask for reconsideration of the decision.

10 August 2024, 10:28 IST

US FDA rejects use of psychedelic MDMA for PTSD patients

10 August 2024, 10:28 IST

Cipla expects to commence supplies to US from China plant later this year

MD and global CEO Umag Vohra informed shareholders that the company is looking to target new therapeutic areas like obesity-related diseases, and liver conditions while investing heavily in tech-based solutions for various ailments.

28 July 2024, 07:00 IST

Cipla expects to commence supplies to US from China plant later this year

28 July 2024, 07:00 IST

Warning letter: USFDA pulls up Sun Pharma for manufacturing issues at Dadra facility

In a warning letter issued to company's Managing Director Dilip Shanghvi on June 18, the US health regulator stated it inspected the plant in the Union Territory of Dadra and Nagar Haveli and Daman and Diu from December 4-15, 2023.

03 July 2024, 14:11 IST

Warning letter: USFDA pulls up Sun Pharma for manufacturing issues at Dadra facility

03 July 2024, 14:11 IST

US lawmakers question FDA's drug inspection programme in India and China

In a letter to FDA Commissioner Robert Califf, the lawmakers on Monday wrote that the difference in inspection outcomes appears to be just another example of institutional weaknesses and dysfunction in the FDA’s foreign drug inspection programme.

25 June 2024, 03:29 IST

US lawmakers question FDA's drug inspection programme in India and China

25 June 2024, 03:29 IST