Granules receives US-FDA approval for sildenafil for oral suspension to treat pulmonary arterial hypertension

Granules receives US-FDA approval for sildenafil for oral suspension to treat pulmonary arterial hypertension

By, Admin 5 December 2023

Granules India Limited announced that the US Food & Drug Administration (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 US market for sildenafil for oral suspension is approximately $43 million, according to MAT Sep 2023, IQVIA/IMS Health.

 

Granules India Limited, incorporated in 1991 is a vertically integrated fast growing Indian pharmaceutical company headquartered at Hyderabad with best in class facilities and commitment to operational excellence, quality, and customer service. The company among the few pharmaceutical companies in the world to be present in the manufacturing of entire value chain – from active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs) and finished dosages (FDs).

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!