Drug Approval | December 28, 2024
Shilpa Medicare's Unit IV receives Eurasia GMP approval
Both units of Shilpa Medicare (Unit IV and Unit VII), have now received GMP approval from Eurasia
Both units of Shilpa Medicare (Unit IV and Unit VII), have now received GMP approval from Eurasia
Jagsonpal Pharmaceuticals has received full consideration of Rs. 41 crore towards the sale of the facility and will now be proceeding with registration formalities
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants
The US District Court of New Jersey decided to grant a preliminary injunction delaying the launch of LEQSELVI
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature
The inspection concluded with the issuance of a form 483 with five observations
This approval reflects company’s unwavering commitment that the quality assurance
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
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