Drug Approval | January 13, 2025
USFDA classifies Biocon Biologics Johor Bahru site, Malaysia as VAI
Biocon Biologics remains committed to global standards of quality and compliance
Biocon Biologics remains committed to global standards of quality and compliance
Successfully transformed the organization from a two-country operation focused on development and manufacturing to a fully integrated company with a strong commercial engine bringing us closer to patients in over 120 countries
The biosimilar Ustekinumab has been developed and manufactured by the company
Biocon Biologics is among the two pharmaceutical companies from India in the 93 companies featuring on the Asia IP Elite 2024 list
The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants
The US District Court of New Jersey decided to grant a preliminary injunction delaying the launch of LEQSELVI
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
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