Gland Pharma receives USFDA approval for Cetrorelix Acetate for injection, expects to launch product in near term

Gland Pharma said on Monday it has received approval from the United States Food and Drug Administration (USFDA) for Cetrorelix Acetate for injection, 0.25 mg/vial.

The company pointed out that the product had sales of approximately $129 million in the United States for the twelve months ending February 2024.

Gland Pharma stated that Cetrorelix Acetate for injection is used to prevent premature luteinizing hormone (LH) surges in women undergoing controlled ovarian stimulation. The company expects to launch the product in the near term through its marketing partner.

Gland Pharma is an injectable-focused company with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets.

The company had recently received USFDA approval for Eribulin Mesylate Injection, 0.5 mg/mL. The product, which has US sales of approximately $92 million for twelve months ending in February 2024, is expected to be the first generic approval on the market, and the firm said it expects to launch this product in the near term through its marketing partner.

During the third quarter of fiscal year 2024, Gland Pharma reported a 65% year-on-year (YoY) rise in its consolidated revenue from operations at ₹1,545.2 crore. Earnings before interest, tax, depreciation and amortisation (EBITDA) grew 23% to ₹355.7 crore. EBITDA margin fell to 23% during the quarter compared to 31% in the same period a year ago. Net profit declined 17% to ₹191.9 crore.

The company pointed out that the US market accounted for 53% of Q3FY24 revenue as against 62% in Q3FY23 while the rest of the world market accounted for 18% of Q3FY24 revenue as against 21% in Q3FY23. India market accounted for 5% of Q3FY24 revenue as compared to 9% in Q3FY23, it said.

Shares of the company have lost nearly 10% since the beginning of the year. The stock is up over 25% in the last one year.