Cohance Lifesciences Limited announced the completion of a United States Food and Drug Administration (USFDA) inspection at its API manufacturing facility in Jaggaiahpet, Andhra Pradesh. The inspection, conducted from September 14 to September 19, 2026, resulted in a Form FDA 483 with five observations. The company is implementing corrective and preventive actions (CAPA) and will submit its response within the stipulated timeline, reaffirming its commitment to quality and regulatory compliance.
| Company | Cohance Lifesciences Limited (formerly, Suven Pharmaceuticals Limited) |
| Inspection Dates | September 14 – September 19, 2026 |
| Facility Location | Jaggaiahpet, Andhra Pradesh, India |
| Inspecting Authority | United States Food and Drug Administration (USFDA) |
| Inspection Outcome | Form FDA 483 issued with five observations |
Facility Inspection and Observations
Cohance Lifesciences Limited has disclosed the outcome of an inspection conducted by the United States Food and Drug Administration (USFDA) at its Active Pharmaceutical Ingredient (API) manufacturing facility located in Jaggaiahpet, Andhra Pradesh, India. The inspection took place from September 14 to September 19, 2026.
Following the inspection, the facility received a Form FDA 483, which detailed five observations. These observations highlight areas identified by the USFDA for potential improvement or compliance related to the manufacturing processes and facility operations.
Corrective Actions and Commitment to Compliance
In response to the observations, Cohance Lifesciences has stated that it has commenced the implementation of appropriate corrective and preventive actions (CAPA). The company is committed to addressing the identified issues promptly and will submit its formal response to the USFDA within the mandated timeframe.
Cohance Lifesciences reiterated its ongoing commitment to maintaining high standards of quality and ensuring full regulatory compliance across all its manufacturing operations. This commitment is crucial for its ongoing relationship with international regulatory bodies and its ability to supply pharmaceutical ingredients to global markets.
Source: BSE
