Unichem Laboratories Gains After USFDA Issues Positive EIR for Roha API Facility

Mumbai, August 26, 2025 – Shares price of Unichem Laboratories Ltd (NSE: UNICHEMLAB, BSE: 506690) surged 4.87% to ₹533.85 as of 15:06 IST on Tuesday, following a positive update from the US Food and Drug Administration (USFDA).

The company informed exchanges that the USFDA has issued an Establishment Inspection Report (EIR) for its Roha Active Pharmaceutical Ingredient (API) facility, classifying the June 16–20, 2025, inspection as Voluntary Action Initiated (VAI), a favorable outcome indicating no major compliance hurdles.

Unichem Laboratories Share Price Update

As of the latest update, the stock was among the top 10 gainers on the NSE. Unichem Laboratories shares closed at ₹514, which is a 1.16% gain on August 26, 2025. Unichem Laboratories shares dipped 11% in the last year, 29% in the year-to-date, and gained 1.21% in the previous month.

The stock opened at ₹510.00, hit a high of ₹557.55, and touched a low of ₹508.15 during the session. The company’s market capitalisation stands at ₹3,620 crore. The stock trades at a P/E ratio of 27.80. Over the past year, it has recorded a 52-week high of ₹937.95 and a 52-week low of ₹483.00.

Regulatory Development

In a filing to the stock exchanges, Unichem stated: “The USFDA has classified the inspection as Voluntary Action Initiated (VAI) and we have received the Establishment Inspection Report (EIR).” This classification signals that the facility has addressed earlier observations satisfactorily, easing regulatory concerns for its US business.

REF: https://nsearchives.nseindia.com/corporate/UNICHEMLAB_26082025145040_IntimationtoSE.pdf

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