Shilpa Medicare Clinches USFDA Green Light: Raichur Unit-1 Earns EIR, Hyderabad Site Gets VAI Nod

Shilpa Medicare Ltd has achieved significant regulatory milestones for its manufacturing and analytical labs. The company has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Unit-1 at Shilpa Pharma Lifesciences, Raichur, Karnataka, after a recent inspection. The inspection, which took place between March 3 to March 7, 2025, was concluded with a sole procedural observation under Form 483, which the company is currently working on in close collaboration with the USFDA. Shilpa Medicare reaffirmed its determination in addressing the observation within the stipulated timeframe, underscoring its dedication to upholding high standards of regulatory compliance and product quality.

 

Parallel to this, Shilpa Medicare's Analytical Services Division in Hyderabad has been rated "Voluntary Action Indicated" (VAI) by the USFDA following a Good Manufacturing Practices (GMP) inspection. VAI rating means that though there were some minor findings, they do not require regulatory or enforcement action and signify the high compliance of the facility with international pharma standards. The facility is a market leader in analytical testing of drug products, drug substances, and raw materials, serving a number of ANDAs and commercial batch testing for US, EU, and other regions.

 

These back-to-back regulatory victories reinforce Shilpa Medicare's strategic emphasis on quality, compliance, and spreading its wings in the global pharma world.

 

Source: Angel One, India Infoline, Medical Dialogues