Granules Pharmaceuticals, Inc. receives ANDA Approval for Amphetamine Mixed Salts

Granules India Limited announced today that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of Granules India Limited, 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.

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 Limited was last trading in BSE at Rs. 340.70 as compared to the previous close of Rs. 336.85. The total number of shares traded during the day was 101492 in over 4097 trades.

The stock hit an intraday high of Rs. 342.90 and intraday low of 334.10. The net turnover during the day was Rs. 34492804.00.

Source : Equity Bulls

Keywords

GranulesIndia INE101D01020 GRANULESPharmaceuticals ANDAApproval USFDA AmphetamineMixedSalts