Caplin Steriles Limited, a subsidiary of Caplin Point Laboratories Ltd, has secured final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Haloperidol Decanoate Injection. The approval covers multiple formulations: 50mg/mL and 100mg/mL single-dose vials, as well as 500mg/5mL (100mg/mL) multiple-dose vials.
The approved product is a generic therapeutic equivalent to Janssen Pharmaceuticals' HALDOL (haloperidol decanoate) Injection. According to IQVIA (IMS Health) data, the reference product generated approximately $16.4 million in US sales for the 12-month period ending March 2025.
Therapeutic Application and Market Potential
Haloperidol Decanoate Injection is indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy. The long-acting injectable formulation provides an important treatment option for patients who may have difficulty adhering to daily oral medication regimens.
The approval strengthens Caplin Steriles' growing portfolio of injectable products and positions the company to capture a share of this specialized market segment.
Company Growth and Regulatory Achievements
Caplin Steriles has established itself as a fast-growing sterile product manufacturer with approvals from multiple regulatory bodies including the US FDA, EU-GMP, ANVISA, and INVIMA. The company has filed 48 Abbreviated New Drug Applications (ANDAs) in the US market to date, with 38 approvals already secured.
"This approval further validates our development capabilities in complex injectable formulations," said a company representative. "It represents another milestone in our strategy to expand our presence in the US pharmaceutical market."
The company is actively focusing on expanding its range of injectable and ophthalmic products, with plans to file more than 40 additional products for regulatory approval over the next four years. Beyond the US market, Caplin Steriles has filed multiple products for approval in other international markets including Australia, Canada, and the UAE.
Parent Company Profile
Caplin Point Laboratories Ltd, the parent company of Caplin Steriles, is a rapidly growing pharmaceutical firm primarily serving emerging markets in Latin America and Africa. The company operates state-of-the-art manufacturing facilities producing a wide range of finished dosage forms.
Following the announcement, Caplin Point Laboratories' share price on the NSE (CAPLIPOINT) was trading at ₹2,018.50, reflecting an increase of ₹15.00 (0.75%). The company has achieved a market capitalization of approximately ₹15.34K crore, with a P/E ratio of 29.89 and a dividend yield of 0.25%.
Strategic Significance
This latest USFDA approval represents an important addition to Caplin Steriles' growing portfolio of injectable products. The approval not only enhances the company's product offerings but also strengthens its competitive position in the global pharmaceutical market.
With its continued focus on sterile injectables and ophthalmic products, Caplin Steriles is positioning itself as a significant player in specialized pharmaceutical segments that require advanced manufacturing capabilities and regulatory expertise.
