In an exchange filing made during market hours today, the company said that Caplin Steriles has been granted final approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) Ketorolac Tromethamine Injection, a generic therapeutic equivalent version of (RLD), TORADOL injection of Roche.

Ketorolac Tromethamine Injection USP is a nonsteroidal anti-inflammatory drug (NSAID), indicated for the short-term management of moderately severe acute pain.

According to IQVIA (IMS Health), Ketorolac Tromethamine Injection USP had US sales of approximately $53 million for the 12-month period ending December 2022.

C. C. Paarthipan, chairman of Caplin Point Laboratories, commented: "Our regulated markets business continues to grow at a robust pace, and this new approval will help augment the growth. We have also received a few approvals from other markets such as Canada and Australia and we look forward to launches there within this year too.”

Caplin Steriles is a niche sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP and ANVISA.

Caplin Point Laboratories is engaged in the business of pharmaceuticals - producing, developing and marketing wide range of generic formulations and branded products and exporting to overseas market.

The pharma company's consolidated net profit jumped 30.1% to Rs 97.48 crore on 14.1% rise in net sales to Rs 372.07 crore in Q3 FY23 over Q3 FY22.