Dr Reddy's Gets USFDA Nod with VAI Status for Srikakulam Plant

Dr Reddy's Laboratories Ltd reports that it has obtained an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its formulations manufacturing plant (FTO 11) in Srikakulam, Andhra Pradesh.

The inspection was comprehensive of Good Manufacturing Practices (GMP) and a Pre-Approval Inspection (PAI), and was performed earlier this year; it was formally closed on 20 October 2025.

In regulatory filing, the Hyderabad-based drugmaker reported USFDA determined inspection results as "Voluntary Action Indicated (VAI)" indicating that the US regulatory agency, while noting some observations in the inspection of the facility, did not intend to pursue any regulatory or enforcement action.

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The meaning of VAI is an indication that the facility complied with the major compliance criteria established by the US regulator, and that minor issues were not expected to adversely impact product approvals or exports.

The inspection had initially been disclosed to the exchanges on July 18, 2025, following the completion of the USFDA visit. The receipt of the EIR now officially closes the inspection process.

This is a positive development for Dr Reddy's Laboratories as it supports Dr Reddy's Laboratory's compliance track record and ensures the supply of formulations to the important US market continues.  The VAI classification also strengthens the company's global manufacturing credibility and allows Dr Reddy's Laboratories to pursue its growth strategy in regulated markets.