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Caplin Steriles Ltd granted final approval by USFDA for Thiamine Hydrochloride Injection ANDA



Posted On : 2023-03-08 11:45:24( TIMEZONE : IST )

Caplin Steriles Ltd granted final approval by USFDA for Thiamine Hydrochloride Injection ANDA

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 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."

Shares of Caplin Point Laboratories Limited was last trading in BSE at Rs. 663.80 as compared to the previous close of Rs. 663.70. The total number of shares traded during the day was 5512 in over 514 trades.

The stock hit an intraday high of Rs. 678.10 and intraday low of 659.00. The net turnover during the day was Rs. 3681068.00.

Source : Equity Bulls

Keywords

CaplinPointLaboratories INE475E01026 Pharmaceuticals CaplinSterlies ANDA ThiamineHydrochlorideInjection MultiDoseVial