Indoco Remedies Varenicline Tablets gets USFDA nod to aid smoking cessation treatment

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-11-01 07:30 GMT   |   Update On 2024-11-01 07:30 GMT
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Mumbai: Indoco Remedies Ltd. has announced the final approval of the Company's Abbreviated New Drug Application (ANDA) for Varenicline Tablets, 0.5 mg and 1 mg, to market a generic equivalent to the reference listed drug (RLD), Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V. (PF) from USFDA.

Varenicline Tablets, 0.5 mg and 1 mg bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V. (PF).

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This product, Varenicline Tablets, 0.5 mg and 1 mg will be manufactured by Indoco Remedies Limited, at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa – 403722 in India.

Varenicline is used to aid smoking cessation treatment.

Commenting on the achievement, Aditi Panandikar, Managing Director said, “Besides reflecting the capability of Indoco Remedies to deliver products of high-quality standards, this development also provides impetus to our growth aspirations in an important market such as the US.”

Read also: Indoco Remedies receives USFDA approval for allergy drug Cetirizine Hydrochloride

Indoco is a fully integrated, research-oriented pharmaceutical company with presence in 55 countries. The Company’s turnover is US$ 200 million. The Company has 9 manufacturing facilities, 6 for FDFs and 3 for APIs, supported by a state-of-the-art R&D Centre and a CRO facility. The facilities have been approved by most of the Regulatory Authorities including USFDA and UK-MHRA. Indoco develops and manufactures a wide range of pharmaceutical products for the Indian and international markets. It generates more than 107 million prescriptions annually from over 2,30,000 doctors belonging to various specialties. Indoco has 9 domestic marketing divisions with a brand portfolio in various therapeutic segments including Gastro-intestinal, Respiratory, Anti-Infective, Stomatologicals, Ophthalmic, Nutritionals, Cardiovascular, Anti-Diabetics, Pain Management, Gynecology, etc. Top Indoco brands include Cyclopam, Febrex Plus, Sensodent-K, Karvol Plus, ATM, Oxipod, Cital, Sensoform, SensodentKF, Cloben-G, Glychek, Kidodent, Carmicide, Rexidin, MCBM 69, Methycal, Homide, Cal-Aid, etc. On the international front, Indoco has tie-ups with large generic companies across the globe.

Read also: Indoco Remedies secures USFDA nod for Lofexidine Tablets 0.18 mg



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