Natco Pharma gains after U.S. FDA classification of Hyderabad formulations facility as VAI 

Natco Pharma shares gained more than 3% on Thursday in the backdrop of generic drugmaker’s formulations facility in Hyderabad receiving an establishment inspection report from the U.S. Food and Drug Administration.

The U.S FDA has issued a EIR classifying the facility as voluntary action indicated (VAI), Natco Pharma said in a update to the stock exchange on the inspection conducted by the regulator in June. The company’s shares ended 3.13% higher at Rs.884.30 apiece on the BSE.

The facility was inspected by the U.S. FDA from June 9-19 and on conclusion of the same received seven observations in Form-483. The facility is for oral solid dosages, including cytotoxic orals; cytotoxic injectables; and pre filled syringes. The focus product categories are oncology, gastroenterology, central nervous system and cardiology.

In April 2024, the U.S. FDA had issued a warning letter to the facility and raised quality concerns. This followed an inspection and issue of eight observations in October 2023 by the regulator. Natco Pharma then said the move may result in delay or withholding of pending product approvals from the site.

Voluntary action indicated (VAI) classification, post inspection of a facility, by the U.S. FDA means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. It is one of three classifications – No action indicated (NAI), which means no objectionable conditions or practices were found during the inspection; official action indicated (OAI) that means regulatory and/or administrative actions are recommended being the other two.