Caplin Point Laboratories’ arm gets USFDA’s nod for Thiamine Hydrochloride Injection

08 Mar 2023 Evaluate

Caplin Point Laboratories’ Subsidiary Company -- Caplin Steriles (Caplin) has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Thiamine Hydrochloride Injection USP, 200 mg/2 mL (100 mg/mL) Multi-dose Vial, a generic therapeutic equivalent version of (RLD), Thiamine Hydrochloride injection of Fresenius Kabi USA LLC.

Thiamine Hydrochloride Injection is effective in the treatment of Thiamine (Vitamin B1) deficiency or beriberi, a serious condition caused by prolonged lack of Vitamin B1. According to IQVIA (IMS Health), Thiamine Hydrochloride Injection had US sales of around $38 million for the 12-month period ending September 2022.

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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