Caplin Point Labs subsidiary gets US FDA nod for schizophrenia treatment drug Haloperidol
Caplin Point Laboratories said that its subsidiary Caplin Steriles has been granted final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Haloperidol Decanoate Injection.
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 Point Laboratories is a pharmaceutical company with a unique business model catering predominantly to emerging markets in Latin America and Africa. The company has manufacturing facilities that cater to a complete range of finished dosage forms.
The companys consolidated net profit grew 18.6% to Rs 138.96 crore on a 13.2% increase in revenue from operations to Rs 492.96 crore in Q3 FY25 over Q3 FY24.
The scrip rose 0.25% to currently trade at Rs 2009.65 on the BSE.
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