Strides gets US nod for first ANDA

Strides Arcolab, the Bangalore-based exporter of branded generic pharmaceutical products, has got its first abbreviated new drug application (ANDA) approval from the USFDA for Keterolac Tromethamine Injection USP, 15 mg/ml and 30 mg/ml. 

According to Arun Kumar, vice chairman and managing director, Strides Arcolab, the product is licensed to Akorn-Strides, which is a joint venture formed in 2004 by Akorn and Strides Arcolab.

Ketrolac is the first approval amongst 22 sterile submissions the company has submitted with the United States Food and Drug Administration (USFDA), and follows a successful FDA approval of its sterile manufacturing facility in India.