The TGA approval marks a pivotal step in Rusan Pharma’s expansion into the Australian market
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
The inspection conducted by EDQM at its Visakhapatnam facility
The sANDA was submitted as “Prior Approval Supplement” for addition of an alternate drug product manufacturing, labeling, packaging, and testing facility
This strong performance was primarily on account of a one-time gain from the strategic collaboration between Biocon Biologics and Eris Lifesciences.
The Unit has been issued GMP Certification from ANVISA-Brazil
Renews GMP certifications for India and Malaysia sites
A five-day inspection was concluded successfully with no critical and no major observations raised
GMP certification helps enable biotechnology customers to accelerate accessibility of new RNA-based therapies for patients
This request for withdrawal of the two dossiers was made after necessary consultations and receiving guidance from EMA
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