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
The company expects this approval in Baddi to pave the way for GMP certifications from European Medicines Agency and other PIC/S member nations
The facility will have a capacity to manufacture upto 3 million tubes monthly
The company expects the GMP approval from Saudi Food and Drug Authority (SFDA) to soon pave the way for marketing authorizations from the largest market in the GCC region
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