Drug Approval | November 10, 2024
Granules India’s Unit V facility secures USFDA EIR with NAI status
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
The recognition from Malaysia's NPRA, a member of PIC/S, opens doors to new global business opportunities
The GMP certificate will allow the manufacturing site in Hervás, Cáceres to manufacture active ingredients for the pharmaceutical industry that is based on medicinal plants
The inspection conducted by EDQM at its Visakhapatnam facility
The sample seized by CDSCO is not manufactured by Torrent and is in fact non-genuine and spurious
This approval reflects company’s unwavering commitment that the quality assurance
USFDA concludes inspection of Dr. Reddy's Laboratories R&D centre in Bachupally with zero observation
Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.
The recent inspection covered both cGMP and PAI processes
The company will take all necessary steps to work with USFDA towards earliest remediation of the above facility
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