USFDA nod to generic therapeutic equivalent version of Janssen Pharma Haldol injection
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-05-14 10:08 GMT | Update On 2025-05-14 10:08 GMT
Chennai: Caplin Steriles Limited, a Subsidiary Company of Caplin Point Laboratories Limited, has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Haloperidol Decanoate Injection, 50mg/mL and 100mg/mL Single Dose Vials; 500mg/5mL (100mg/mL) Multiple-Dose Vials.
The product 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 Limited, a Subsidiary of Caplin Point Laboratories Limited, is a sterile product manufacturing company that is approved by several regulatory agencies such as US FDA, EU-GMP, ANVISA and INVIMA. The has developed and filed 48 ANDAs in USA on its own and with partners, with 38 approvals so far. The Company is also working on a portfolio of 40+ simple and complex Injectable and Ophthalmic products that it intends to file over the next 4 years. The company also has multiple products filed with several approvals in non-US markets such as Australia, Canada, Mexico, Chile, UAE, Hong Kong, Malaysia, etc.
Its parent company, Caplin Point Laboratories Limited, is a fast-growing pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa. The Company has state of the art manufacturing facilities that cater to a complete range of finished dosage forms. Caplin Point has appeared on Forbes “Asia’s 200 Best Under a Billion” list for an unprecedented 7 th time in the last 10 years.
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