Synopsis:
NATCO Pharma’s Hyderabad facility received the USFDA’s EIR with a “Voluntary Action Indicated” classification, implying no regulatory action. The company termed the inspection procedural and assured comprehensive compliance measures.
During Thursday’s trading session, shares of one of the leading globally vertically integrated pharmaceutical companies with a focus on R&D to manufacture niche and complex molecules surged nearly 5 percent on BSE, after the U.S. Food and Drug Administration (FDA) closed inspection without urging action.
At 11:46 a.m., the shares of NATCO Pharma Limited were trading in the green at Rs. 885.05 on BSE, up by around 3 percent, as against its previous closing price of Rs. 857.5, with a market cap of Rs. 15,852 crores. The stock has delivered negative returns of around 42 percent in one year, but has gained by over 1 percent in the last one month.
What’s the News
As per the latest regulatory filings, NATCO Pharma Limited announced that the U.S. Food and Drug Administration (FDA) had recently conducted an inspection of its pharmaceutical division located in Kothur, Hyderabad, India. The facility has now received an Establishment Inspection Report (EIR), with the FDA classifying it as “Voluntary Action Indicated (VAI)”.
As per the FDA guidelines, a VAI classification means the agency does not intend to pursue or recommend any administrative or regulatory action. NATCO clarified that the inspection was procedural in nature and expressed confidence in its ability to address the observations comprehensively.
Financials
NATCO Pharma reported a marginal decline in revenue from operations, experiencing a year-on-year fall of nearly 2 percent, from Rs. 1,363 crores in Q1 FY25 to Rs. 1,329 crores in Q1 FY26. Similarly, the company’s net profit decreased during the same period from Rs. 668 crores to Rs. 480 crores, representing a decline of nearly 28 percent YoY.
NATCO Pharma Limited is engaged in the business of pharmaceuticals and agricultural chemicals, comprising research and development (R&D), manufacturing and selling of bulk drugs, finished dosage formulations. The company creates, produces and sells finished dosage formulations (FDF), active pharmaceutical ingredients (API) and agrochemicals (technical and formulation). In the API segment, it has capabilities to develop and manufacture products with multi-step synthesis, semi-synthetic fusion technologies, high-potency APIs and peptides. It has manufacturing facilities in India, serving both domestic and international markets, including regulated markets like the United States of America and Europe.
Written by Shivani Singh
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