Drug Approval | September 29, 2024
Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma
Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations
Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations
This approval reflects company’s unwavering commitment that the quality assurance
Glenmark Pharmaceuticals Limited has informed that the USFDA has issued Form 483 with zero observations
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
Investment in new plant meets increasing demand for functional excipients for oral drug delivery
Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.
He will lead the final stages of work to commission the 54,000-square-foot facility and then lead ongoing operations at the site
Also received tentative approval for 137 mg
The JV will establish a state-of-the-art manufacturing facility to manufacture fermented animal free protein to cater to the global markets
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