A US FDA preapproval inspection raises more questions about the readiness of the Biocon Ltd. biosimilars manufacturing facility in India that European authorities have found to be non-compliant with EU GMP requirements.
An FDA team issued a Form 483 report of inspectional observations made at the facility on April 7, just three weeks after France's inspectorate visited the site, which Biocon
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?