NATCO Pharma Limited announced on February 13, 2026, that it has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its Active Pharmaceutical Ingredient (API) unit located in Manali, Chennai. The inspection, which took place between November 17 and November 21, 2025, resulted in the FDA classifying the inspection outcome as Voluntary Action Indicated (VAI). This positive outcome confirms the facility’s compliance status with US FDA standards.
Positive U.S. FDA Inspection Outcome
NATCO Pharma Limited has officially communicated the receipt of the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) concerning its API manufacturing facility situated in Manali, Chennai. This disclosure was made on February 13, 2026.
Inspection Details and Classification
The inspection by the U.S. FDA at the Active Pharmaceutical Ingredient Division in Chennai was conducted over five days, specifically from November 17, 2025, through November 21, 2025. During this review, the company had noted receiving seven observations documented on Form-483. However, the formal EIR received now classifies the inspection outcome as Voluntary Action Indicated (VAI). This classification signifies that while observations were noted, the FDA does not require immediate further significant corrective action beyond the company’s intended follow-up.
Company Background
NATCO Pharma Limited is headquartered in Hyderabad and focuses on developing, manufacturing, and distributing generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients, and crop protection products. The company maintains a strong orientation towards R&D and is recognized as a leading Oncology player in targeted therapies. NATCO operates 9 manufacturing sites and 2 R&D facilities in India, with its various manufacturing sites approved by major global regulatory bodies including the US FDA, Brazil ANVISA, and Health Canada, serving 50+ global markets.
Source: BSE
