USFDA grants final nod to Caplin Point arm for Tranexamic Acid Injection

Tranexamic Acid Injection is a generic therapeutic equivalent version of Cyklokapron Injection, 100 mg/ml, of Pharmacia & Upjohn Company.

Chennai: Caplin Steriles Limited, a Wholly Owned Subsidiary of Caplin Point Laboratories Limited, has recently announced that the company 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.

The product is 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.

Read Also: Caplin Point’s sterile injectable site in Chennai gets two USFDA observations

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.

The company has over 2800 product approvals across the globe with another 250+ in the pipeline. The company's subsidiary Caplin Steriles Ltd caters to the Regulated Markets for Injectable and Ophthalmic products.

Read Also: Caplin Point gets 2 USFDA observations for sterile injectable site in Chennai