United States Food and Drug Administration (USFDA) has completed a Good Manufacturing Practices (GMP) inspection at Cohance Lifesciences’ Finished Dosage Formulations Manufacturing Facility (FDF Unit-I) located in Nacharam, Hyderabad. The inspection was conducted from August 4, 2025 to August 12, 2025 excluding the weekend of August 9 and 10, 2025.
Following the inspection, the Company has received a Form 483 from the USFDA with 06 observations. These are predominantly procedural in nature.
Cohance Lifesciences (Formerly, Suven Pharmaceuticals) is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialization.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1665.70 |
| Dr. Reddys Lab | 1220.00 |
| Cipla | 1232.60 |
| Zydus Lifesciences | 928.05 |
| Lupin | 2305.00 |
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