Caplin Point Laboratories said that its subsidiary Caplin Steriles has secured final approval for its abbreviated new drug application (ANDA) for Thiamine Hydrochloride Injection USP, 200 mg/2 mL (100 mg/mL) Multi-dose Vial from the US Food and Drug Administration (FDA).

The approved product is a generic version of Fresenius Kabi USA’s THIAMINE HYDROCHLORIDE injection. It is indicated for the treatment of Thiamine (Vitamin B1) deficiency or beriberi, a serious disorder resulting from a prolonged lack of Vitamin B1.

Thiamine Hydrochloride Injection had sales of around $38 million in the US for the 12-month period ending September 2022, as per IQVIATM (IMS Health).

CC Paarthipan — Caplin Point Laboratories Chairman said: “We’re glad to receive 3 back to back ANDA approvals recently, taking the tally to 16 approvals for Caplin Steriles and 4 more with partners. These recent approvals will not only help the company’s current targets, but also the future.”

Recently, Caplin Steriles got final approval for Rocuronium Bromide Injection, 10 mg/mL in 5 mL and 10 mL Multi-dose Vials from the FDA.

  beriberi, Caplin Point Laboratories, Caplin Steriles, CC Paarthipan, Fresenius Kabi, Thiamine, US FDA, US Food and Drug Administration, USA, Vitamin B1