Shares of Caplin Point rose more than 10% to Rs 709 per share in Friday’s intraday trade after the United States Food and Drug Administration (USFDA) approved subsidiary Caplin Steriles’ abbreviated new drug application (ANDA) for ketorolac tromethamine injection, an anti-inflammatory drug used to cure moderate-to-severe acute pain.

Cumulative sales of ketorolac tromethamine injection in the US market for the 12 months ending December 2022 were about $53 million, according to US research firm IQVIA.

With this approval, management asserts that it will help strengthen further growth.

“Our regulated market business continues to grow at a strong rate, and this new approval will help to boost growth. We have also received several approvals in other markets such as Canada and Australia, which we also look forward to launching within the year, said C C Paarthipan, Chairman of Caplin Point Laboratories.

Caplin Point is a fast-growing pharmaceutical company primarily serving emerging markets in Latin America and Africa. The company has manufacturing facilities capable of producing a complete line of finished dosage forms and derives 100% of its revenue from the export market. It has also entered regulated markets such as the United States, Canada, and Australia through its subsidiary, Caplin Steriles.

The subsidiary Caplin Sterlies is a niche sterile product manufacturing company approved by USFDA, EU-GMP, ANVISA and other regulatory agencies. So far, 30 ANDAs have been developed and declared in the US, and 21 have been approved.

On the financial front, analysts at Sharekhan expect Caplin Point’s total sales to rise as much as 22% year-over-year, driven by growth in the US and Latin America. They added that growth in the injectables business in the US and expansion into new regions would further boost sales.

Still, analysts said operating margins may have declined year-over-year due to other operational expenses. The brokerage is taking a ‘positive’ stance on the counter with a target price of Rs 811 per share.

Shares of Caplin Point were down 0.4% so far this calendar year (CY23), compared with a 1% gain for the S&P BSE Sensex.