Natco Pharma Shares Jump 3.23% as USFDA Approves VAI Status for Kothur Plant

Mumbai, 18 September 2025: Natco Pharma Limited (NSE: NATCOPHARM, BSE: 524816) saw its shares jump 3.23%, trading at ₹884.90 at 1:27 pm IST on Thursday after a major regulatory announcement by the US Food and Drug Administration (USFDA) regarding its Kothur plant in Hyderabad.

Founded in 1981 and listed on 27 December 1995, Natco Pharma is a Hyderabad-based company with its presence in the pharmaceuticals industry, having expertise in finished dosage formulations and active pharmaceutical ingredients (APIs). The firm is a constituent of the NIFTY Smallcap 250 Index, reflecting its position among mid-cap pharmaceutical companies in India.

3.23% Share Spike Driven by Regulatory Clearance as USFDA Gives VAI Status

The recent USFDA inspection of Natco Pharma’s facility at Kothur ended in a Voluntary Action Indicated (VAI) rating. VAI is a status that reflects the facility’s general compliance with regulatory requirements, with minor observations that do not necessitate major corrective actions. Accordingly, the plant has been permitted to produce and export pharmaceutical products to the US market, removing any possible regulatory doubts for the firm.

Market Reaction Emphasizes Surge and Trading Patterns

Natco Pharma shares opened at ₹859.95 after the news, hitting an intraday high of ₹896.95 and a low of ₹855.60. The stock had trading volume indicating high market activity, and the company’s market capitalisation was ₹15,850 crore. During the last 52 weeks, the stock has traded between ₹726.80 and ₹1,561.70, showing sustained volatility with regulatory updates.

Key Performance Indicators Reflect Positive Momentum

Natco Pharma’s price-earnings (P/E) ratio was at 9.34, the quarterly dividend per share is ₹1.26, with a dividend yield of 0.57%. The stock movement is also a year-on-year recovery from a 52-week low of ₹726.80 in April 2025, led partially by regulatory clarity at its key Kothur facility. USFDA’s VAI classification has eliminated potential overhangs that might have impacted operational confidence and export continuity.

The USFDA VAI status for Natco Pharma Ltd’s Kothur plant reinforces compliance with the regulator and ensures uninterrupted supply and exports to the US, underpinning operational stability. Sustained compliance with international quality norms is also expected to uphold the company’s reputation in the global pharma market.

REF: https://nsearchives.nseindia.com/corporate/NATCOPHARM_18092025094438_DisclosuretoSE18092025.pdf

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