Inspection Closed, Confidence Restored—Dr Reddy’s Facility Gets Green Light

Dr Reddy’s Laboratories Ltd has received the Establishment Inspection Report (EIR) from the US Food & Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) facility in Middleburgh, New York. The inspection, conducted from May 12 to May 16, 2025, concluded with a Voluntary Action Indicated (VAI) classification.

 

Key Highlights:

 

- VAI status means minor violations were found but do not warrant regulatory action

 

- The inspection is officially closed under 21 CFR 20.64 (d)(3)

 

- Two observations were issued via Form 483, which the company is addressing within the stipulated timeline

 

- The facility remains eligible to manufacture and distribute approved products and file new applications

 

- Dr Reddy’s continues to maintain its global compliance standards across key markets

 

Strategic Outlook:

 

The outcome reinforces Dr Reddy’s operational credibility and supports its expansion in the US generics and API segment.

 

Sources: CNBCTV18, Business Standard, Medical Dialogues.