The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets
Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well
Renews GMP certifications for India and Malaysia sites
There was no observation related to data integrity reported
Dr. Reddy's Laboratories gets Form 483 from USFDA with 4 observations for API facility
The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations
EDQM conducts GMP inspection of SMS Pharmaceuticals’ API facility
The clearance of this audit marks the successful registration of 8 APIs with CADIFA
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