Indoco Remedies Bags US FDA Tentative Nod For Canagliflozin Tablets

India Pharma Outlook Team | Thursday, 07 December 2023

 India Pharma Outlook Team

Indoco Remedies Ltd. reported the receipt of a provisional US FDA approval for an Abbreviated New Drug Application (ANDA) for canagliflozin tablets 100 mg and 300 mg, a generic equivalent of Janssen Pharmaceuticals, Inc.'s Reference Listed Drug, Invokana tablets 100 mg and 300 mg.

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, as per pharmabiz.    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.”   Indoco is a fully integrated, research-oriented pharmaceutical corporation with a global footprint in 55 countries.  The company has a turnover of $200 million and a human capital of 6,000 personnel, including over 400 experienced scientists and field professionals who represent the organization's strength.

They have nine manufacturing facilities, six of which are for completed doses and three for APIs, as well as a cutting-edge R&D center in Rabale, Navi Mumbai, and a Clinical Research Organization in Hyderabad. Our manufacturing facilities meet the highest regulatory requirements, complying with WHO-cGMP principles, and have been approved by a number of regulatory bodies, including the USFDA, UK-MHRA, TGA-Australia, SAHPRA-South Africa, NDA-Uganda, TMDA-Tanzania, MOH-Ukraine, PPB-Kenya, DPML-Ivory Coast, and others.

Indoco has expanded its international footprint and now provides complete solutions to generic firms globally, including product development, manufacturing, and supply of Finished Dosages, APIs, and Intermediates.

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