Caplin Point Laboratories was up 2.21% to Rs 423 at 13:29 IST on the BSE after the company said its received US drug regulator's approval for Tranexamic Acid injection
The announcement was made during market hours yesterday, 18 July 2019.
Meanwhile, the S&P BSE Sensex was down by 113.29 points, or 0.29% to 39,102.72.
On the BSE, 5711 shares were traded in the counter so far compared with average daily volumes of 2126 shares in the past two weeks. The stock had hit a high of Rs 429.8 and a low of Rs 412.45 so far during the day. It hit a 52-week high of Rs 535 on 10 September 2019 and a 52-week low of Rs 304.75 on 29 January 2019.
Caplin Point Laboratories said its wholly owned subsidiary, Caplin Steriles, received final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Tranexamic Acid injection USP, 1000mg/10ml (100mg/mL) vial, a generic therapeutic equivalent version of Cyklokapron Injection, 100 mg/ml, of Pharmacia & Upjohn Company.
Tranexamic Acid injection is administered in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
According to IQVIA (IMS Health), Tranexamic Acid had US sales data of approximately $30 million for the 12 month period ending March 2019. Caplin Steriles, has developed and filed 11 ANDAs on its own and with partners, with 5 approvals so far. The company is also working on a portfolio of 35 simple and complex injectable and ophthalmic products, to be filed over the next 4 years.
On consolidated basis, Caplin Point Laboratories' net profit increased 41% to Rs 49.86 crore on a 30.6% rise in net sales to Rs 187.34 crore in Q4 March 2019 over Q4 March 2018.
Caplin Point Laboratories is a pharmaceutical company catering predominantly to emerging markets of Latin America and Africa.
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