Zydus Lifesciences Limited announced the successful completion of a US Food and Drug Administration (USFDA) inspection at its injectable medical devices manufacturing facility in Ahmedabad.
The inspection outcome, which concluded without any observations, reflects regulatory compliance at the inspected unit.
The disclosure was made under SEBI’s listing regulations and comes amid ongoing regulatory scrutiny across global pharmaceutical manufacturing operations.
The USFDA conducted a Pre-Approval Inspection (PAI) at the company’s Unit 9 facility located at Zydus Biotech Park in Changodar, Ahmedabad. The inspection took place over four days, from February 16 to February 19, 2026.
The review focused on injectable medical devices manufactured at the facility, forming part of the regulatory process required before product approvals in the United States market.
According to the company’s announcement, the inspection concluded with nil observations, meaning the regulator did not issue any Form 483 observations or compliance-related remarks at the end of the review.
Such outcomes generally indicate that manufacturing processes, quality systems and documentation were found to be aligned with regulatory expectations during the inspection period.
The company communicated the development to stock exchanges under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The disclosure aims to keep investors informed about material regulatory developments that may have operational relevance.
The company requested exchanges to disseminate the information to investors and market participants.
Shares of Zydus Lifesciences were trading marginally lower during the session despite the regulatory update. As of 11:30 AM on February 20, the stock was quoted at ₹900.65, down ₹1.85 or 0.21% compared with the previous close of ₹902.40.
During the day’s trade, the stock opened at ₹905.80 and moved within a range of ₹898.30 to ₹908.00, indicating limited price volatility.
Read More:Dr Reddy’s Share Price in Focus After Progynova and Cyclo Progynova Acquisition in India.
The successful closure of the USFDA inspection without observations marks a regulatory milestone for Zydus Lifesciences’ injectable manufacturing operations. While the outcome reinforces compliance standards at the facility, market reaction remained muted, with investors likely continuing to monitor future product approvals and operational developments.
Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. This does not constitute a personal recommendation/investment advice. It does not aim to influence any individual or entity to make investment decisions. Recipients should conduct their own research and assessments to form an independent opinion about investment decisions.
Investments in the securities market are subject to market risks, read all the related documents carefully before investing.
Published on: Feb 20, 2026, 11:52 AM IST
Neha Dubey
Neha Dubey is a Content Analyst with 3 years of experience in financial journalism, having written for a leading newswire agency and multiple newspapers. At Angel One, she creates daily content on finance and the economy. Neha holds a degree in Economics and a Master’s in Journalism.
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