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Indoco Remedies Varenicline Tablets gets USFDA nod to aid smoking cessation treatment
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).
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
Read also: Indoco Remedies secures USFDA nod for Lofexidine Tablets 0.18 mg
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751