Drug Approval | October 02, 2024
SMS Pharma receives EDQM certification to supply Ibuprofen in Europe
The inspection conducted by EDQM at its Visakhapatnam facility
The inspection conducted by EDQM at its Visakhapatnam facility
The inspection concluded with the issuance of a form 483 with five observations
The sample seized by CDSCO is not manufactured by Torrent and is in fact non-genuine and spurious
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 sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility
Investment in new plant meets increasing demand for functional excipients for oral drug delivery
The recent inspection covered both cGMP and PAI processes
Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.
The company will take all necessary steps to work with USFDA towards earliest remediation of the above facility
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