FDA 483 - Suven Pharmaceuticals Limited - August 05, 2026

Cohance Lifesciences Limited, an API and finished drug manufacturer in Sangareddy, India, was cited for significant deficiencies in its quality control and manufacturing processes. Observations included unvalidated analytical methods, inadequate OOS investigations, deficient change control procedures, and poor material handling practices. These issues raise concerns about the quality and integrity of drug products distributed to the U.S. market.