Drug Approval | September 20, 2024
Briefs: Dr. Reddy's Laboratories and Torrent Pharmaceuticals
USFDA concludes inspection of Dr. Reddy's Laboratories R&D centre in Bachupally with zero observation
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
The new Injectable Facility housed in Akums Healthcare started commercial production on 22nd August 2024, with a capacity of 362 million units annually
USFDA has determined that the inspection classification of this facility is "No Action Indicated" (NAI) with zero 483 observation
Collaboration with KNAUER to streamline and improve the scale-up of LNP formulations
European markets now contribute 51% of our business revenue up from 43% in Q4 FY24 and 34% in Q1 FY24
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