USFDA nod to Caplin Steriles Thiamine Hydrochloride Injection

Chennai: Caplin Steriles Limited, a Subsidiary Company of Caplin Point Laboratories Limited, has been granted final approval by 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.

The product is 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 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.”

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