Clarity in regulatory frameworks and pathways help in preventing delays in accessing quality-assured, affordable medicines
US$ 800 million senior secured notes, the largest high yield debut USD bond issuance from India in the last 10 years
The inspection concluded with the issuance of a form 483 with five observations
The Notes shall not be offered or sold in India
These clinical studies support the interchangeability of adalimumab-fkjp at low-concentration with high-concentration adalimumab and ustekinumab biosimilarity
Biocon Biologics earlier announced a settlement agreement in the United States for a Bmab 1200 launch no later than February 22, 2025
The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants
Renews GMP certifications for India and Malaysia sites
The approval of YESAFILI marks Biocon Biologics’ expansion into the ophthalmology therapeutic area in the United States
Both organisations enter into a long- term collaboration to expand patient access in India
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