FDA closes inspection at Zydus' oncology injectable manufacturing facility in SEZ1, Ahmedabad with 2 observations

The USFDA conducted a Pre-Approval Inspection at SEZ Oncology Injectable manufacturing site in SEZ1, Ahmedabad, in relation to the new isolator injectable line. The inspection was conducted from 4th to 13th November, 2025 and concluded with two observations. There were no data integrity related observations. The Company will closely work with the USFDA to address the observations expeditiously.

FDA concludes Unit 1 of Divi's Laboratories with zero observation

Divi's Laboratories Limited 's Unit-I facility at Lingojigudem Village, Choutuppal Mandal, Yadadri Bhuvanagiri district, Telangana, has been inspected by the US Food and Drug Administration (USFDA) from November 10, 2025 to November 14, 2025. This inspection was a general cGMP inspection by the USFDA. The inspection has been concluded with no 483 observations.

Relonchem receives marketing authorization for two products

Marksans Pharma Limited announces that its wholly owned subsidiary Relonchem Limited in UK has received Marketing Authorization for its following products from UK MHRA: mefenamic acid 250 mg film-coated tablets and mefenamic acid 500 mg film-coated tablets.