Caplin Steriles Wins USFDA Approval for Haloperidol Injection, Strengthening US Generics Portfolio

Image Source: Free Press Journal

Caplin Steriles, the injectable-focused subsidiary of Caplin Point Laboratories Ltd, has received a significant boost with the US Food and Drug Administration (USFDA) granting approval for its Haloperidol Injection. This milestone further cements Caplin Steriles’ growing presence in the US generics market and underscores its robust capabilities in sterile product development.

Key Highlights:

USFDA Approval for Haloperidol Injection: The green light from the USFDA allows Caplin Steriles to market Haloperidol Injection in the United States, expanding its portfolio of critical care and psychiatric medications. Haloperidol is widely used in hospitals for the management of acute psychosis, agitation, and severe behavioral disorders.
Strengthening US Market Footprint: This approval follows a series of successful USFDA nods for Caplin Steriles, including recent clearances for Phytonadione Injectable Emulsion and Ephedrine Sulfate Injection. The company now boasts over 35 USFDA approvals, with a pipeline of more than 40 injectable and ophthalmic products under development or pending approval.
Revenue and Market Impact: The US market for generic injectable antipsychotics like Haloperidol represents a substantial opportunity, supporting Caplin’s strategy to tap into high-value hospital and critical care segments.
Global Regulatory Strength: Caplin Steriles’ manufacturing facilities are approved by major global agencies, including USFDA, EU-GMP, ANVISA, and INVIMA, ensuring compliance with the highest quality standards.
Growth Outlook: With this latest approval, Caplin Steriles continues to strengthen its pipeline and market reach, reinforcing Caplin Point Laboratories’ position as a leading supplier of complex sterile generics to regulated markets.