USFDA concludes inspection of Biocon's insulin drug substance manufacturing facility

07 Mar 2019 Evaluate

US Food and Drug Administration (USFDA) has concluded a pre-approval inspection of Biocon's insulin drug substance manufacturing facility triggered by a New Drug Application (NDA).

The inspection at the Bengaluru facility took place on February 25 - March 05, 2019, resulting in a Form 483 with six observations.

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation-driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.

Biocon Share Price

392.80 4.55 (1.17%)
05-Dec-2025 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1804.95
Dr. Reddys Lab 1275.05
Cipla 1520.55
Zydus Lifesciences 931.45
Lupin 2097.65
View more..
Register Now to get our Free Newsletter & much more!

© 2025 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×