Indoco Remedies Limited announced today that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Varenicline Tablets. The approved generic drug, available in 0.5 mg and 1 mg strengths, is equivalent to PF Prism C.V.’s Chantix Tablets, used for smoking cessation treatment.
The shares of Indoco Remedies Limited were trading at ₹310, up by ₹8.25 or 2.73 per cent on the NSE today at 12:05 pm.
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The company will manufacture the drug at its Verna, Goa facility. Managing Director Aditi Panandikar stated that the approval demonstrates the company’s ability to deliver high-quality products and supports its growth plans in the US market.
Indoco Remedies, a research-oriented pharmaceutical company with a turnover of $200 million, operates nine manufacturing facilities - six for finished dosage forms and three for active pharmaceutical ingredients. The company maintains a presence in 55 countries and employs 6,000 people, including 400 scientists.
In India, Indoco generates over 107 million prescriptions annually through nine domestic marketing divisions, serving more than 230,000 doctors. The company’s product portfolio spans multiple therapeutic segments, including gastrointestinal, respiratory, anti-infective, and cardiovascular medications, among others.