Caplin Point’s subsidiary Caplin Steriles receives USFDA approval for ophthalmic solution

Caplin Point Laboratories announced on Friday that its subsidiary Caplin Steriles has received the final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Phenylephrine hydrochloride ophthalmic solution USP 2.5% and 10% (eye drops). The solution is a generic therapeutic equivalent of the reference listed drug (RLD) from Alcon Research. Shares of Caplin Point Laboratories were trading 0.70% lower on Friday.

The company stated that according to IQVIA’s sales data, Phenylephrine hydrochloride ophthalmic solution had recorded sales in the United States amounting to $32 million in FY24. Caplin Steriles has filed for 41 ANDAs in the United States, of which 28 have been approved so far. The company is working on a portfolio of over 40 simple and complex injectable and ophthalmic products which it intends to file over the next 4 years. The company also has multiple products filed with several approvals in non-US markets such as Mexico, Australia, Canada, and South Africa among others.

Caplin Laboratories recently announced that it received approval from Colombia’s National Institute of Food and Drug Surveillance (INVIMA) for its Softgel Capsules division at Puducherry. INVIMA approved the facility as it met the good manufacturing practices (GMP) and good laboratory practices (GLP) norms.

In the fourth quarter of fiscal year 2024, Caplin Point Laboratories recorded a 20% year-on-year (YoY) growth in its consolidated net profit at ₹121.23 crore. The company’s revenue from operations grew 16.4% YoY to ₹453.22 crore. Earnings before interest, tax, depreciation, and amortisation (EBITDA) grew 20.1% to ₹162.52 crore. EBITDA margin improved to 34.5% during the quarter as compared to 33.8% in the same period a year ago.

Shares of the company have declined by nearly 4% since the beginning of the year. The stock has gained over 75% in the last one year.