The injection is available in 1000mg/10ml (1O0mg/mL) vial.
Caplin Point Laboratories shares rallied nearly 4 percent intraday on July 18 after the US drug regulator approved injection that prevents excessive blood loss.
"Caplin Steriles Limited, a wholly owned subsidiary, has been granted final approval from the United States Food and Drug Administration for its abbreviated new drug application (ANDA) Tranexamic acid injection," the company said in its BSE filing.
The injection is available in 1000mg/10ml (1O0mg/mL) vial. Tranexamic is a generic therapeutic equivalent version of Cyklokapron injection 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) data, the drug had US sales data of approximately $30 million for the 12-month period ending March 2019, company said.
Caplin Steriles has developed and filed 11 ANDAs on its own and with partners, with 5 approvals so far. The company said it is also working on a portfolio of 35 simple and complex injectable and ophthalmic products to be filed over the next 4 years.The stock was quoting at Rs 423, up Rs 9.15, or 2.21 percent on the BSE at 1321 hours IST.