Indoco Remedies bags USFDA tentative nod for Canagliflozin and Metformin Hydrochloride Tablets for type 2 diabetes mellitus
Mumbai: Indoco Remedies Ltd. has announced the receipt of tentative approval
from the U.S. Food and Drug Administration (USFDA) for Abbreviated New Drug Application (ANDA) for Canagliflozin and
Metformin Hydrochloride Tablets, 50 mg/500 mg, 50 mg/1000 mg, 150 mg/500 mg, and 150
mg/1000 mg.
The product is a generic equivalent of Invokamet Tablets, 50 mg/500 mg, 50 mg/1000 mg,
150 mg/500 mg and 150 mg/1000 mg.
Canagliflozin and Metformin Hydrochloride Tablets, will be manufactured by
Indoco Remedies Limited, at their manufacturing facility located at L-14, Verna Industrial
Area, Verna, Goa – 403722 in India.
Canagliflozin and Metformin Hydrochloride Tablets are
used to treat type 2 diabetes mellitus.
Commenting on the achievement, Aditi Panandikar, Managing Director said, “We are
excited to receive tentative approval from the USFDA for our Canagliflozin and Metformin
Hydrochloride Tablets. This milestone underscores our commitment to bringing affordable
and effective treatment options to patients managing type 2 diabetes.”
Indoco is a fully integrated, research-oriented pharmaceutical company with a strong global presence. The
Company’s turnover is US$ 212 million. The Company has 11 manufacturing facilities, 7 for FDFs and 4 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 106 million prescriptions annually from over 2,35,000
doctors belonging to various specialties. Indoco has 8 domestic marketing divisions a brand portfolio in
various therapeutic segments including Gastro-intestinal, Respiratory, Anti-Infective, Stomatologicals,
Ophthalmic, Nutritionals, Cardiovascular, Anti-Diabetics, Pain Management, Gynaecology, etc. Top Indoco
brands include Cyclopam, Febrex Plus, Sensodent-K, Karvol Plus, ATM, Oxipod, Cital, Sensoform, Sensodent-KF,
Aloja, Glychek, Kidodent, Subitral, Rexidin, MCBM 69, Methycal, Dropizine, Noxa, Homide, Cal-Aid, etc.
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