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 positive outcome clears the way for Glenmark to resume commercial manufacturing at the site
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025
The facility has been classified as Voluntary Action Indicated
The company received one observation in the Form-483
This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms
The receipt of EIR reaffirms the company's commitment to maintaining global quality standards
Zydus receives EIR for the API manufacturing facility at Ankleshwar
Apitoria Pharma’s API manufacturing facility classified as VAI by USFDA
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