Drug Approval | September 30, 2024
USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia
The inspection concluded with the issuance of a form 483 with five observations
The inspection concluded with the issuance of a form 483 with five observations
This approval reflects company’s unwavering commitment that the quality assurance
Fermenta Biotech’s API manufacturing facility receives EU GMP compliance certificate
USFDA concludes inspection of Dr. Reddy's Laboratories R&D centre in Bachupally with zero observation
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
Subscribe To Our Newsletter & Stay Updated
