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Caplin Steriles, a subsidiary of Chennai-based Caplin Point Laboratories Ltd, on Wednesday announced it has received USFDA approval for its thiamine hydrochloride injection, making it the third injection to receive the US drug regulator’s approval in the last one month.
On March 3, the company announced that it has received the US drug regulator’s approval for its Rocuronium Bromide injection, a neuromuscular blocking agent provided during surgery or mechanical ventilation. In February, Caplin Steriles received USFDA’s final approval for Carboprost Tromethamine Injection, which is used to treat severe bleeding after childbirth (postpartum).
Thiamine hydrochloride Injection, for which the company received the latest approval, is generic therapeutic equivalent version of thiamine hydrochloride injection manufactured by US-based Fresenius Kabi LLC. The injection is used in the treatment of Thiamine (Vitamin B1) deficiency or beriberi, a serious condition caused by prolonged lack of Vitamin B1.
CC Paarthipan, Chairman of Caplin Point Laboratories Ltd, said the company is glad to receive three back-to-back ANDA (Abbreviated New Drug Application) approvals taking the tally to 16 approvals for Caplin Steriles and four more with partners.
On NSE, stocks of Caplin Point closed at ₹658.20 on Wednesday, down 1.20 per cent over Tuesday’s close.
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