The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
Takes over the commercialization of Biosimilars Business from Viatris in 70+ countries
The launch of HULIO in the United States is an important milestone for Biocon Biologics
This approval reflects Biocon Biologics' compliance with the highest international regulatory standards
Biocon Biologics Limited will have access to 100 million doses of vaccines annually together with the distribution rights to Serum's Vaccine portfolio
Tambe has been with Biocon since 1997 and has held diverse leadership and operational roles.
To fund the upfront payment, Biocon Biologics has secured USD 1.2 billion of Sustainability Linked Loan
This is the fifth consecutive year that a Biocon Group company has made it to the Asia lP ELITE list
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
Yoshindo gets exclusive commercialization rights in Japan for bUstekinumab and bDenosumab developed and manufactured by Biocon Biologics
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