Caplin Steriles gets US FDA approval for generic blood pressure drug

The company has so far developed and filed 13 ANDAs on its own and with partners, and received six approvals

Caplin Steriles’ Abbreviated New Drug Application (ANDA) for a generic version of blood pressure drug Nitropress, originally sold by Pfizer, has received the United States Food and Drug Administration’s (US FDA’s) final approval.

A wholly owned subsidiary of Caplin Point Laboratories Ltd, Caplin Steriles said it had received approvals for Sodium Nitroprusside injection, 50 mg/2 ml (25 mg/ml) Vial, a generic therapeutic equivalent version of Nitropress 50 mg/vial of Hospira Worldwide. Pfizer Inc completed the acquisition of Hospira in September 2015.

According to IQVIA (formerly IMS Health and Quintiles), sodium nitroprusside had sales of around $8 million in the US for 12 months ended March 2019. Caplin Steriles has developed and filed 13 ANDAs on its own and with partners, and received six approvals so far.

C C Paarthipan, chairman of Caplin Point Laboratories, said: "This is the third ANDA approval for Caplin Steriles and we hope to have a few more in the next few months, which should help us close the year strongly."

Besides, its entry into captive active pharmaceutical ingredient (API) manufacturing for several of its ANDAs will augment its control over compliance, cost and continuity in supply. The company is also working on a portfolio of 35 simple and complex injectable and ophthalmic products to be filed over the next four years.