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.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1832.90 |
| Dr. Reddys Lab | 1307.40 |
| Cipla | 1366.80 |
| Zydus Lifesciences | 936.95 |
| Lupin | 2465.55 |
| View more.. | |
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