Indoco Remedies secures FDA tentative approval for Canagliflozin Tablets


Indoco Remedies Ltd., a renowned player in the global pharmaceutical industry, has announced receiving tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Canagliflozin Tablets in 100 mg and 300 mg strengths. These tablets are the generic equivalent of the Reference Listed Drug, Invokana Tablets, originally developed by Janssen Pharmaceuticals, Inc.

Canagliflozin Tablets: A Key Player in Diabetes Treatment

The Canagliflozin Tablets, manufactured by Indoco Remedies Limited at their Goa-based facility (Plant – I) in India, are poised to improve glycemic control in adults with type 2 diabetes mellitus. This approval marks a significant milestone in offering effective and affordable treatment options for diabetes, a growing global health concern.

FDA Nods to Indoco Remedies' Generic Version of Invokana for Diabetes Treatment

FDA Nods to Indoco Remedies’ Generic Version of Invokana for Diabetes Treatment

Indoco Remedies: A Global Pharmaceutical Powerhouse

Indoco Remedies Ltd. is a fully integrated, research-oriented pharmaceutical company with a robust presence in 55 countries. The company boasts nine manufacturing facilities – six for Finished Dosage Forms (FDFs) and three for Active Pharmaceutical Ingredients (APIs). Supported by a state-of-the-art R&D Center and a Clinical Research Organization (CRO) facility, Indoco Remedies is committed to delivering products of high-quality standards.

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Impact of Indoco Remedies’ Latest Achievement on the Healthcare Sector

Aditi Panandikar, the Managing Director of Indoco Remedies Ltd., commented on the achievement, stating that this development not only reflects the company’s capability to deliver high-quality products but also bolsters its growth aspirations in crucial markets like the US. The tentative approval for Canagliflozin Tablets is a testament to Indoco Remedies’ dedication to addressing global health challenges and signifies a leap forward in the company’s growth trajectory.

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