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Shares of Caplin Point advanced over 10 per cent to Rs 709 per share in Friday's intra-day trade, after the United States Food and Drug Administration (USFDA) granted final approval to subsidiary Caplin Steriles' abbreviated new drug application (ANDA) for ketorolac tromethamine injection, an anti-inflammatory drug used to cure moderate-to-severe acute pain.
According to US-based research firm IQVIA, ketorolac tromethamine injection accumulated sales of around $53 million in the US markets for the 12-month period ending December 2022.
With this approval, the management asserts that it would help accentuate further growth.
"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," said C C Paarthipan, Chairman of Caplin Point Laboratories.
Caplin Point is a fast-growing pharmaceutical company catering predominantly to emerging markets of Latin America and Africa. The company has manufacturing facilities that cater to a complete range of finished dosage forms, and derives 100 per cent of its revenue from export markets. It has also entered regulated markets such as the US, Canada, Australia through its subsidiary Caplin Steriles.
Subsidiary-Caplin Sterlies, on the other hand, is a niche sterile product manufacturing company approved by several regulatory agencies such as USFDA, EU-GMP, and ANVISA. So far, it has developed and filed 30 ANDAs in the US, with 21 approvals.
Financially, for the January-March quarter of FY23 (Q4FY23), analysts at Sharekhan expect Caplin Point to clock up to 22 per cent YoY total sales, driven by growth in the US and Latin America markets. Growth in injectables business in the US, and expansion in newer geographies would further drive sales, they added.
That said, operating profit margins are likely to decline YoY due to other operating expenses, analysts said. The brokerage firm has shared a 'positive' stance on the counter, with Rs 811 per share target price.
So far this calendar year (CY23), shares of Caplin Point have declined 0.4 per cent, as against 1 per cent rise in the S&P BSE Sensex.
