Caplin Point to tap into $35m market after FDA approval for NIMBEX generic

Caplin Point to tap into $35m market after FDA approval for NIMBEX generic

Caplin Steriles, a subsidiary of India’s Caplin Point Laboratories, has obtained final approval from the US Food and Drug Administration (FDA) for its generic version of AbbVie’s NIMBEX injection. The approved drug, Cisatracurium Besylate Injection USP, is expected to be a significant player in a market that, according to IQVIA (IMS Health), generated US sales […]

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

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 […]