Cohance Lifesciences Limited, formerly Suven Pharmaceuticals Limited, has informed the stock exchanges about the completion of a USFDA inspection at its API manufacturing facility. The inspection took place at Jaggaiahpet, Andhra Pradesh from September 14 to September 19, 2026.
Key Inspection Outcome
5 Observations Under Form FDA 483
The United States Food and Drug Administration inspection concluded with issuance of a Form FDA 483 containing five observations. The facility inspected is identified by FEI No. 3005554260 located at Jaggaiahpet, Andhra Pradesh, India.
CAPA and Response Timeline
The company has initiated appropriate corrective and preventive actions, known as CAPA, and will submit its response within the stipulated timeline prescribed by the USFDA. The company remains committed to quality and regulatory compliance.
About The Facility
Jaggaiahpet API Manufacturing Unit
The inspected site is an Active Pharmaceutical Ingredient manufacturing facility situated at Jaggaiahpet in Andhra Pradesh. API facilities are critical for supply of raw materials used in finished dosage formulations for regulated markets like the US.
Company Name Change
The company was earlier known as Suven Pharmaceuticals Limited and is now operating as Cohance Lifesciences Limited. The scrip symbol on NSE is COHANCE and scrip code on BSE is 543064.
What Does Form 483 Mean
- Regulatory Note: Form FDA 483 is issued when USFDA investigators observe conditions that may violate regulations during an inspection.
- Not Final Action: It is not a final warning letter but requires the company to respond with corrective actions.
- Common in Pharma: Observations related to documentation, procedures or compliance systems are common and addressable through CAPA.
- Next Step: Company will submit detailed response and implement corrective measures to satisfy USFDA expectations.
Intimation Details
The intimation was filed on September 21, 2026 to National Stock Exchange of India Limited and BSE Limited by Company Secretary and Compliance Officer Sisir K Mishra for information and record.