Shilpa Medicare Ltd

🔍 USFDA Inspection Update: Shilpa Medicare’s Unit IV Receives 8 Observations

- USFDA inspection at Shilpa Medicare’s Unit IV (Jadcherla, Telangana) concluded on Nov 21, 2025.

- FDA issued Form 483 with 8 observations—none were repeat findings.

- Facility produces sterile injectables, oral tablets, and capsules for US, Europe, and other global markets.

- US sales from this unit contributed <1% of total revenue in H1 FY25-26 and <5% in FY24-25.

- Unit holds approvals from EMA (Europe), Health Canada, Anvisa (Brazil), and TGA (Australia).

- Company will address observations within the required timeline.