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.