Caplin Steriles gets USFDA approval for Thiamine Hydrochloride Injection
Drug Approval

Caplin Steriles gets USFDA approval for Thiamine Hydrochloride Injection

Thiamine Hydrochloride Injection is effective in the treatment of vitamin B1 deficiency (beriberi)

  • By IPP Bureau | March 09, 2023

Caplin Steriles Limited, a subsidiary company of Caplin Point Laboratories Limited, 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 (beriberi), a serious condition caused by prolonged lack of Vitamin B1. According to IQVIA (IMS Health), Thiamine Hydrochloride Injection had US sales of approximately US $38 million for the 12-month period ending September 2022.

C. C. Paarthipan, Chairman of Caplin Point Laboratories Limited 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.”

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