The new facility uses the latest mammalian systems and single-use technology, including a production line with eight 2,000 L bioreactors
The inspection concluded with the issuance of a form 483 with five observations
Chobhe brings over 30 years of extensive experience in quality and regulatory management within the pharmaceutical industry
This marks the first regulatory approval worldwide for nasally-delivered epinephrine
The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
The expiry date of almost all strips is rubber stamped vanish in a matter of 3 to 4 months, making the remaining tablets waste for subsequent use before expire date
Largest investment in active pharmaceutical ingredient manufacturing of synthetic medicines in U.S. history
Cellares will dedicate multiple Cell Shuttle and Cell Q systems with fully automated, high-throughput quality control for Bristol Myers Squibb’s exclusive use
A five-day inspection was concluded successfully with no critical and no major observations raised
The certification underscores Venus Remedies Limited's adherence to stringent quality control measures
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