Shilpa Medicare Limited has informed the Exchange Disclosure under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 EIR from USFDA, for Shilpa Medicare Ltd. Unit VI, Bengaluru.
SHILPAMED · price
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Shilpa Medicare's Unit VI in Dabaspet, Bengaluru received an Establishment Inspection Report (EIR) from the USFDA with a VAI (Voluntary Action Indicated) classification. This follows the GMP inspection conducted from October 24–30, 2024. The facility manufactures Oral Dissolving Films and Transdermal Systems, and is already approved by EMA (Europe), MHRA (UK), SFDA (Saudi Arabia), and TGA (Australia). The unit currently supplies Oral Film products to the US and other markets, and Transdermal products have been filed in Europe. A VAI classification means the facility is broadly compliant and no mandatory corrective action is required from the regulator.
Positive for the stock — a clean USFDA outcome removes regulatory overhang and supports continued US exports from this facility, strengthening confidence in compliance standards.