Natco Pharma's Hyderabad unit gets 7 USFDA Form 483 observations

• USFDA issues seven Form 483 observations to Natco Pharma's Hyderabad unit
• Inspection conducted between June 9 and June 19 at Kothur facility
• Company assures corrective measures and commitment to cGMP compliance

Natco Pharma announced on Thursday, its receipt of a Form 483 from the United States Food and Drug Administration (USFDA), with seven observations, after an inspection of its pharma unit in Hyderabad. The inspection took place from June 9 to June 19, 2025, at Natco's Kothur site.

In a regulatory filing, the company said it was informed of these observations at the end of the inspection process. A Form 483 is issued by the USFDA to communicate to a company that inspectional conditions may have the potential to violate the Food Drug and Cosmetics Act or related regulations. While the issuance of a Form 483 does not signal the final agency decision, it nonetheless acknowledges the need for timely corrective action.

Natco was confident in its ability, to address the cited problems in accordance with the respective timelines. Natco reiterated its commitment to follow current Good Manufacturing Practices (cGMP) and deliver high-quality pharmaceutical products to customers around the world.

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This event highlights the regulatory pressures that Indian pharma companies encounter to uphold strict compliance standards for markets around the globe. Natco stated that it is implementing corrective actions and actively engage with regulators to achieve complete compliance and operational excellence.