Caplin Point Laboratories’ arm gets USFDA approval for Argatroban Injection

22 Jan 2021 Evaluate

Caplin Steriles (Caplin), a Subsidiary Company of Caplin Point Laboratories, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Argatroban Injection, 50 mg/50 ml (1 mg/ml) Single-dose vial presentation, a generic therapeutic equivalent version of (RLD), ARGATROBAN INJECTION, of Hikma Pharmaceuticals.

Argatroban is used as an anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia. According to IQVIA (IMS Health), Argatroban Injection had US sales data of approximately $18 million for the 12-month period ending September 2020.

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.

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