Shilpa Medicare's Jadcherla unit receives eight USFDA observations

Shilpa Medicare Limited's Unit IV facility in Jadcherla, Telangana, successfully completed a USFDA inspection on November 21, 2025. The ten-day inspection concluded with the issuance of an FDA Form 483, detailing eight inspectional observations. None of these observations were categorized as repeat observations. The company stated it will respond comprehensively to these observations within the stipulated timeframe.

The Jadcherla facility is approved by major international regulators, including EMA (Europe), Health Canada, Anvisa (Brazil), and TGA (Australia). It specializes in manufacturing, packaging, testing, storage, and distribution of sterile injectables, oral tablets, and capsules, supplying these products to the US, Europe, and other global markets.

Sales from products manufactured at this plant constituted less than 1% of the company's total business for the first half of fiscal year 2025-26 and less than 5% for fiscal year 2024-25, indicating a relatively minor contribution to overall revenue.