Indoco Remedies Canagliflozin Tablets For Type 2 Diabetes Adults Get USFDA Tentative Okay

Written By Ruchika Sharma     Published On 6 Dec 2023 5:01 PM | Updated On 6 Dec 2023 5:01 PM

Canagliflozin improves glycemic control in adults with type 2 diabetes mellitus.

Mumbai: Indoco Remedies Ltd. has announced the receipt of tentative approval from the United States Food and Drug Administration (USFDA) for Abbreviated New Drug Application (ANDA) for Canagliflozin Tablets 100 mg and 300 mg.

The product is a generic equivalent of the Reference Listed Drug, Invokana Tablets 100 mg and 300 mg, of Janssen Pharmaceuticals, Inc.

This product will be manufactured by Indoco Remedies Limited, at their manufacturing facility located at Goa (Plant -I) in India.

Canagliflozin improves glycemic control in adults with type 2 diabetes mellitus.

Commenting on the achievement, Ms. 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.”

Indoco is a fully integrated, research-oriented pharmaceutical company with presence in 55 countries. 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 strong 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, Sensodent-KF, 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.