Regulatory Disclosure Summary
NATCO Pharma Limited has submitted a regulatory disclosure pursuant to Regulation 30 of the SEBI (Listing Obligations & Disclosure Requirements) Regulations, 2015 regarding the conclusion of a U.S. Food and Drug Administration (FDA) inspection.
Inspection Details
- The US FDA conducted an inspection at the company's Finished Dosage Formulations (FDF) manufacturing plant located in Parawada, Visakhapatnam, Andhra Pradesh, India
- The inspection period was from August 17th, 2026 to August 21st, 2026
Inspection Outcome
- Upon conclusion of the inspection, the company was issued a Form 483
- The Form 483 contains 4 (Four) observations
- The company believes that the observations are procedural in nature
- The company expressed confidence in addressing these observations comprehensively within stipulated timelines
Company Background
NATCO Pharma Limited develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharma ingredients and crop protection products. The company is headquartered in Hyderabad, India and is a R&D oriented, science-driven leading Oncology player. The company's manufacturing facilities are approved by several leading regulatory authorities including US FDA, Brazil ANVISA, Health Canada, and WHO, catering to 50+ global markets.