Mumbai, May 14 -- The approved drug is a generic therapeutic equivalent version of the reference listed drug (RLD) HALDOL (haloperidol decanoate) Injection, by Janssen Pharmaceuticals Inc.

Haloperidol Decanoate Injection indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.

According to IQVIA (IMS Health), Haloperidol Decanoate Injection had US sales of approximately $16.4 million for the 12-month period ending March 2025.

Caplin Steriles is a sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP, ANVISA and INVIMA. It has developed and filed 48 ANDAs in USA on its own and with partners, with 38 approvals so far.

Caplin ...