Caplin Point Laboratories Limited has informed the Exchange regarding a press release dated May 14, 2025, titled "Press Release regarding receipt of USFDA Approval".
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Caplin Point Laboratories' subsidiary, Caplin Steriles Limited, has received final approval from the USFDA for its generic version of Haloperidol Decanoate Injection, used to treat schizophrenia. The approval covers 50mg/mL and 100mg/mL single-dose vials and 500mg/5mL multiple-dose vials, making it a generic equivalent of Janssen's HALDOL. According to IQVIA, the US market for this drug is about $16.4 million annually (12 months ending March 2025). Caplin Steriles has now secured 38 USFDA approvals out of 48 ANDAs filed, and has a pipeline of 40+ injectable and ophthalmic products planned over the next 4 years.
This adds another product to Caplin Steriles' US portfolio, supporting incremental US revenue. While the addressable market for this particular drug is modest at ~$16.4 million, the consistent stream of approvals underscores the subsidiary's growing US presence and execution capability, which is positive for long-term growth.