Caplin Steriles Limited, a wholly-owned subsidiary of Caplin Point, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tranexamic Acid Injection USP, 1000mg/10ml (lO0mg/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 a tooth extraction, the company said in the filing.
According to IQVIA (IMS Health), Tranexamic Acid had US sales data of approximately $30 million for the 12 months 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, it added.
Caplin Point Laboratories Ltd is currently trading at Rs426.15, up by Rs12.3 or 2.97% from its previous closing of Rs413.85 on the BSE.
The scrip opened at Rs415.45 and has touched a high and low of Rs429.80 and Rs412.45 respectively.
No comments