Caplin Point Laboratories’ arm gets USFDA’s nod for Tranexamic Acid Injection

18 Jul 2019 Evaluate

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) Tranexamic Acid Injection USP, 1000mg/10ml (l00mg/mL) vial, a generic therapeutic equivalent version of Cyklokapron Injection, 100 mg/ml, of Pharmacia & Upjohn Company.

According to IQVIA (IMS Health), Tranexamic Acid had US sales data of approximately $30 million for the 12 month period ending March 2019. Caplin Steriles has developed and filed 11 ANDAs on its own and with partners.

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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