Granules India Limited Received ANDA Approval for Sildenafil for Oral Suspension

Granules India Limited announced today that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA), filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the company, for Sildenafil for Oral Suspension, 10 mg/mL. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Revatio for Oral Suspension, 10mg/ml, of Viatris Specialty LLC.

Sildenafil for Oral Suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening.

Granules now has a total of 63 ANDA approvals from the US FDA (61 final approvals and 2 tentative approvals).

The current annual U.S. market for Sildenafil for Oral Suspension is approximately $43 million, according to MAT Sep 2023, IQVIA/IMS Health.

Shares of Granules India Limited was last trading in BSE at Rs. 392.70 as compared to the previous close of Rs. 399.65. The total number of shares traded during the day was 114418 in over 3944 trades.

The stock hit an intraday high of Rs. 404.75 and intraday low of 391.80. The net turnover during the day was Rs. 45521024.00.

Source : Equity Bulls

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GranulesIndia INE101D01020 USFDA ANDA Approval Sildenafil OralSuspension