Inspection outcome reinforces company's
compliance track record and strengthens its ability to serve regulated markets
including the United States
Mumbai6: 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 compliance 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.