Biocon Biologics' Drug Substance Facility in Bengaluru cassified as VAI
This relates to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States
This relates to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States
The audit was completed with zero critical and zero major observations
Most recently, Yuvraj was the Director of Operations, Business Development & Process Excellence at Zeon Lifesciences Ltd
Nitrosamines have prompted evolving global guidelines that demand rigorous industry oversight
The approval by the US FDA comes after extensive safety testing and manufacturing improvements
The positive outcome clears the way for Glenmark to resume commercial manufacturing at the site
Clinical studies conducted in India demonstrated that this nebulized triple therapy rapidly improves lung function and offers better control of breathlessness
Renalyx will continue operating as an independent unit within the group
RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA submission and commercialization of the product in the US
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