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
The transaction is part of a broader agreement with Bureau Veritas covering its worldwide food laboratory testing activities
The certification marks a new chapter in Windlas Biotech’s growth trajectory,
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024
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 inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.
Expects to unlock further opportunities in the Moldovan market, contributing anticipated sales of $300,000 in 2025 and approximately $700,000–$800,000 in 2026
Both units of Shilpa Medicare (Unit IV and Unit VII), have now received GMP approval from Eurasia
This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP
The company has received the GMP Certification after successful closure of the inspection
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