Shilpa Medicare gets USFDA Form 483 with eight observations

Shilpa Medicare disclosed that the U.S. Food and Drug Administration (USFDA) released a Form 483 containing eight inspectional findings for its Unit IV facility located in Jadcherla, Telangana.

As stated in an exchange filing, the ten-day inspection of the facility, held from 12 November to 21 November 2025, resulted in the issuance of Form 483 containing eight observations. All observations have not been classified as repeat observations.

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The facility can produce, package, test, store, and distribute sterile injectables, oral tablets, and capsules, serving markets in the US, Europe, and other parts of the world.

The firm reported that US sales from this facility represented under 1% of its overall operations in H1 FY25-26 and under 5% in FY24-25. The unit has received approval from key regulatory agencies such as EMA (Europe), Health Canada, Anvisa (Brazil), and TGA (Australia).

Shilpa Medicare stated that it will provide a thorough response to the inspectional observations within the specified timeframe. Shilpa Medicare produces API formulation, and development services. The consolidated net profit of the company jumped 145.7% to Rs 44.07 crore in Q2 FY26 compared to Rs 17.94 crore reported in Q2 FY25.