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Granules Pharmaceuticals receives ANDA approval for Amphetamine Mixed Salts (IR Tablets)
Hyderabad-based Granules India Limited today announced that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc.
Hyderabad-based Granules India Limited today announced that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc. (GPI) for Amphetamine Mixed Salts, USP 1.25mg, 1.875mg, 2.5mg, 3.125mg, 3.75mg, 5mg, 7.5mg Immediate-Release Tablets. It is bioequivalent to the reference listed drug product (RLD), _Adderall of Teva Women's Health Inc. The product would be available for the US market shortly.
Granules Pharmaceuticals, Inc. (GPI) is a wholly-owned foreign subsidiary of Granules India Limited.
Commenting on the approval Ms. Priyanka Chigurupati, Executive Director, GPI, said "We are pleased to receive the approval of the controlled substance product and will surely be a valuable addition to our growing product portfolio in the US market. We will be launching the product shortly."
Granules now have a total of 47 ANDA approvals from the US FDA (45 Final approvals and 2 tentative approvals).
The current annual U.S. market for Amphetamine Mixed Salts, USP 1.25mg, 1.875mg, 2.5mg, 3.125mg, 3.75mg, 5mg, 7.5mg Immediate Release Tablets strengths is approximately $ 335 Million, according to MAT, Oct 2021 IQVIA/IMS Health.
Shares of Granules India was trading at Rs 336.80, down 1.13 per cent, against the closing price of the previous session of Rs 340.65 at the NSE at 10:57 am.
Incorporated in 1991 Granules India Limited is a vertically integrated fast-growing Indian pharmaceutical company headquartered in Hyderabad with best in class facilities and commitment to operational excellence, quality, and customer service. It is among the few pharmaceutical companies in the world to be present in the manufacturing of the entire value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs). Our products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 75+ countries with offices across India, U.S. and U.K. The Company has 7 manufacturing facilities out of which 6 are located in India and 1 in the USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.