USFDA nod to Caplin Steriles Thiamine Hydrochloride Injection

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.

Published On 2023-03-09 10:45 GMT   |   Update On 2023-03-09 10:45 GMT
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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.

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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.”

Read also: Caplin Steriles bags USFDA nod for Rocuronium Bromide Injection

Caplin Steriles Limited, a Subsidiary of Caplin Point Laboratories Limited, is a niche sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP and ANVISA. Caplin Steriles Limited, has developed and filed 29 ANDAs in USA on its own and with partners, with 20 approvals so far. The Company is also working on a portfolio of 40+ simple and complex Injectable and Ophthalmic products, that it intends to file over the next 4 years.
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