April 22, 2026

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Supriya Lifescience Receives USFDA EIR With VAI Classification For Maharashtra API Facility.

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Mumbai, Maharashtra, 22nd of April 2026 : Supriya Lifescience Limited, a leading API manufacturer, today announced the USFDA has issued an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) classification for its API facility at Lote Parshuram, Maharashtra—successfully closing the recent inspection cycle.

The inspection was conducted between February 2 and February 6, 2026. At the conclusion of the inspection, the USFDA issued a Form 483 with one minor observation, to which the company submitted a comprehensive response within the stipulated timeline. This VAI outcome affirms ongoing cGMP compliance, building on the site’s established USFDA track record including prior VAI and NAI classifications.

The VAI classification enables Supriya Lifescience to maintain uninterrupted supplies of APIs to regulated markets such as the United States, Europe, and Japan.

Dr. Satish Wagh, Executive Chairman & Whole Time Director, Supriya Lifescience Supriya Lifescience Limited, said: “Successful closure of the USFDA inspection with this outcome reflects the strength of our quality systems and our consistent focus on regulatory excellence. It reinforces our position as a reliable API partner for global pharmaceutical companies and strengthens our ability to expand in regulated markets such as the United States. We remain committed to maintaining the highest standards of quality and compliance across all our operations.”

The Lote Parshuram facility is the company’s key manufacturing hub, playing a central role in supporting its global customer base and export-led growth strategy, with 81% of FY25 revenue (₹696 Cr) derived from international markets including the United States. Continued regulatory comjtpliance at this site remains integral to ensuring reliable supply of APIs to highly regulated markets and reinforcing the company’s position as a trusted global partner.

Supriya Lifescience continues to focus on strengthening its compliance framework, enhancing operational capabilities, and expanding its footprint in regulated markets as part of its long-term growth strategy.

About Supriya Lifescience Ltd.:

Supriya Lifescience Ltd., a world-renowned producer of active pharmaceutical ingredients, was founded in 1987. Our state-of-the-art facility has certifications from Health Canada, EUGMP, EDQM, USFDA, and NMPA. The company is headquartered in Mumbai, India, and our facility is located in Khed, District Ratnagiri. Our globally compliant facilities USFDA, EDQM, WHO, PMDA, KFDA and ANVISA are supported by robust R&D, eight active CEPs, and fourteen active USDMFs. EHS requirements and ethical principles guide our core business. The company’s primary focus is to build intermediates and APIs for innovators and generic firms. We also exclusively collaborate with partners in the capacity of CMOs.

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