Caplin Point Laboratories Limited has informed the Exchange regarding a press release dated May 14, 2025, titled "Press Release regarding receipt of USFDA Approval".
CAPLIPOINT · price
▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
On the reaction day the stock moved 0.6 pts less than Nifty Smallcap 250 and 0.1 pts less than its Pharmaceuticals peers, over the same two closes: a difference in percentage points, not a measure of what the filing did.
Minute windows have no benchmark: there is no intraday index history to compare against.
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.