The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
The inspection was concluded with two 483 observations
Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets
Aim of the collaboration is to develop mRNA platform technology, scale up and troubleshoot challenges in mRNA process optimization
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
This existing GMP compliant facility, located at Bharuch (Unit-1) with ongoing expansion part of the company's strategic capex initiative
Renews GMP certifications for India and Malaysia sites
Transaction is non-dilutive, with 100% performance-based payment through a royalty model
There was no observation related to data integrity reported
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