Caplin Steriles Receives USFDA Approval for Haloperidol Decanoate Injection

Caplin Steriles Ltd, a subsidiary of Caplin Point Laboratories Ltd, has got final approval from the United States Food and Drug Administration (USFDA) for its generic version of Haloperidol Decanoate Injection. The approved product comes in two forms: 50mg/mL and 100mg/mL single-dose vials, and 500mg/5mL (100mg/mL) multiple-dose vials. It is a therapeutic equivalent to HALDOL (haloperidol decanoate) Injection, developed by Janssen Pharmaceuticals Inc.

Product Use and Market Potential

Haloperidol Decanoate Injection is utilised for treating patients with schizophrenia who require long-term injectable antipsychotic therapy. According to IQVIA (IMS Health), this product generated approximately $16.4 million in US sales for the 12 months ending March 2025.

Read More, BEML Interim Dividend of ₹15 Record Date Tomorrow, May 15, 2025. 

About Caplin Steriles Limited

Caplin Steriles, a fast-growing sterile product manufacturer, is approved by regulatory bodies such as US FDA, EU-GMP, ANVISA, and INVIMA. The company has filed 48 Abbreviated New Drug Applications (ANDAs) in the US, with 38 approvals so far. It is also focusing on a range of injectable and ophthalmic products, with plans to file 40+ products in the next four years. In addition, Caplin Steriles has filed multiple products for approval in non-US markets like Australia, Canada, and the UAE.

About Caplin Point Laboratories Limited

Caplin Point Laboratories Ltd, the parent company of Caplin Steriles, is a rapidly growing pharmaceutical firm catering mainly to emerging markets in Latin America and Africa. The company boasts state-of-the-art manufacturing facilities that produce a wide range of finished dosage forms. 

Caplin Point Laboratories share price (NSE: CAPLIPOINT) is currently trading at ₹2,018.50, up by ₹15.00 (0.75%) as of 11:34 AM IST on May 14. The stock has reached a market cap of ₹15.34K crore, with a P/E ratio of 29.89 and a dividend yield of 0.25%. The quarterly dividend amount is ₹1.26. Its 52-week high stands at ₹2,641.00, while the 52-week low is ₹1,225.00.

Conclusion

This approval enhances Caplin Steriles' portfolio, positioning it for significant growth in the injectable market, while strengthening its presence in global pharmaceutical markets.

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