CAPLIN STERILES GETS USFDA APPROVAL FOR THIAMINE HYDROCHLORIDE INJECTION

Chennai, March 08, 2023: Caplin Steriles Limited (Caplin), a Subsidiary Company of Caplin Point Laboratories Limited (BSE: CAPPL (524742), NSE: CAPLIPOINT), 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 IQVIATM (IMS Health), Thiamine Hydrochloride Injection had US sales of approximately $38 million for the 12-month period ending September 2022.

Mr. C. C. Paarthipan, Chairman of Caplin Point Laboratories Limited commented “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.”