Caplin Point Laboratories’ wholly owned subsidiary -- Caplin Steriles has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Sodium Nitroprusside injection, 50 mg/2 ml (25 mg/ml) Vial, a generic therapeutic equivalent version of NITROPRESS (Sodium Nitroprusside) 50 mg/vial of Hospira Worldwide, INC.
According to IQVIA (IMS Health), Sodium Nitroprusside had US sales data of approximately $8 million for the 12-months period ending March 2019. Caplin Steriles, has developed and filed 13 ANDAs on its own and with partners, with 6 approvals so far.
Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Sodium nitroprusside is also indicated for producing controlled hypotension in order to reduce bleeding during surgery and for the treatment of acute congestive heart failure.
Caplin Point Laboratories is engaged mainly in manufacturing a wide range of Ointments, Creams and other External application preparations in addition to the regular segments of pharmaceutical formulations.
