Caplin Point Laboratories subsidiary gets FDA final approval for Thiamine Hydrochloride Injection

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.