Drug Approval | December 20, 2023
Briefs: Aurobindo Pharma and Granules Pharmaceuticals
Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection
Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection
Laurus Synthesis receives Form 483 with 5 observations from USFDA
Expansion of presence in India with electrical safety, electromagnetic compatibility and medical device biocompatibility, toxicity and microbiology testing and certification services
Dr. Reddy's Laboratories has been issued a Form 483 with three observations
The inspection of the facility conducted from August 7 to August 11, 2023
The company is confident of addressing all the observations within the stipulated time
The USFDA inspectors issued the observations after a product pre-approval inspection of the biologics facility in Bachupally
The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022
Balaxi Healthcare Ecuador S.A.S. has become a Wholly Owned Subsidiary of the company
The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
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