Drug Approval

Cohance Lifesciences reports conclusion of FDA inspection at Shamshabad facility

The USFDA issued a Form FDA 483 with four observations

  • By IPP Bureau | September 06, 2026

Cohance Lifesciences Limited (formerly Suven Pharmaceuticals Limited) has announced regarding the completion of an inspection conducted by the United States Food and Drug Administration (USFDA).

The regulatory inspection was carried out at the company's formulation (FDF) plant situated at Shamshabad, Telangana, between August 27, 2026, and September 4, 2026.

At the conclusion of the audit, the USFDA issued a Form FDA 483 with four observations. The company stated that it has initiated the necessary corrective and preventive actions (CAPA) and plans to file its formal response within the designated timeline.

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