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Dr Reddy's Laboratories Ltd.'s formulations manufacturing facility was given "Form 483" with seven observations from the ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

The FDA cracked down on two plants in India and one in Korea in separate recently released reports, citing issues ranging ...

The defect has resulted in problems including a procedural delay, difficulty removing device fragments and bleeding, the FDA ...

Mumbai: Pharma major Lupin has received multiple observations from the U.S. Food and Drug Administration (USFDA) following ...

Biotech deals involving assets developed in China are surging, a Jefferies report shows. | Biotech deals involving assets ...

For a pharmaceutical company, a clean FDA inspection report is crucial for maintaining and expanding its presence in global markets ...

The U.S. FDA had inspected the API facility, in Mekaguda here, from June 9-13 and issued Form 483 with one observation. The regulator had classified it as “voluntary action indicated” (VAI), the ...

Natco Pharma informed that the U.S. Food and Drug Administration (US FDA) has issued an EIR for its active pharmaceutical ingredient (API) division located in Mekaguda, Hyderabad, Telangana.

Glenmark Pharmaceuticals receives FDA warning letter for Indore facility, commits to resolving compliance issues promptly.