According to an exchange filing, the ten-day inspection of the facility, conducted from 12 November to 21 November 2025, concluded with the issuance of the Form 483 with eight observations. None of the observations have been categorized as repeat observations.

The facility is capable of manufacturing, packaging, testing, storing, and distributing sterile injectables, oral tablets, and capsules, supplying products to the US, Europe, and other global markets. The company said US sales from this plant accounted for less than 1% of its total business in H1 FY25-26 and less than 5% in FY24-25.

The unit is approved by major regulatory authorities, including EMA (Europe), Health Canada, Anvisa (Brazil), and TGA (Australia). Shilpa Medicare added that it will respond comprehensively to the inspectional observations within the stipulated timeline.

Shilpa Medicare is a manufacturer of API, formulation, and development services. The company's consolidated net profit surged 145.7% to Rs 44.07 crore in Q2 FY26 as against Rs 17.94 crore recorded in Q2 FY25. Revenue rose 7.6% YoY to Rs 369.97 crore in the quarter ended 30 September 2025.

The counter rose 0.57% to Rs 352.80 on the BSE.