NATCO Pharma's Mekaguda API Facility Receives FDA Establishment Inspection Report Following Successful Remediation

Key Insights

• NATCO Pharma Limited received an Establishment Inspection Report (EIR) from the U.S. FDA for its Active Pharmaceutical Ingredient facility in Mekaguda, Hyderabad on July 24, 2025.
• The FDA inspection conducted from June 9-13, 2025 resulted in one observation classified as "Voluntary Action Indicated" (VAI), which the company characterized as procedural in nature.
• The successful resolution demonstrates NATCO's commitment to maintaining cGMP compliance and ensuring high-quality API manufacturing for global pharmaceutical supply chains.

NATCO Pharma Limited has successfully completed the regulatory review process following a U.S. Food and Drug Administration inspection at its Active Pharmaceutical Ingredient manufacturing facility in Mekaguda, Hyderabad, with the FDA issuing an Establishment Inspection Report (EIR) on July 24, 2025.

FDA Inspection Outcomes

The FDA conducted a comprehensive inspection of NATCO's API manufacturing plant from June 9-13, 2025. Upon conclusion of the inspection, the company received one observation documented in Form-483, which was subsequently classified as "Voluntary Action Indicated" (VAI) by the regulatory agency.

NATCO characterized the observation as procedural in nature and expressed confidence in addressing the finding comprehensively. The company's ability to successfully remediate the issue and receive the EIR demonstrates effective quality management systems and regulatory compliance capabilities.

Manufacturing Operations and Compliance

The Mekaguda facility represents a critical component of NATCO's API manufacturing operations, serving both domestic and international pharmaceutical markets. The company emphasized its ongoing commitment to maintaining current Good Manufacturing Practice (cGMP) compliance standards throughout its manufacturing operations.

"NATCO remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally," the company stated following the inspection conclusion.

Company Profile and Operations

NATCO Pharma Limited, headquartered in Hyderabad, India, operates as a diversified pharmaceutical manufacturer with capabilities spanning multiple therapeutic areas. The company develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients, and crop protection products.

The successful completion of the FDA inspection process reinforces NATCO's manufacturing quality standards and regulatory compliance framework, supporting continued access to U.S. pharmaceutical markets for the company's API products.