USFDA nod to generic therapeutic equivalent version of Janssen Pharma Haldol injection

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.

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Comments Policy

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

USFDA nod to generic therapeutic equivalent version of Janssen Pharma Haldol injection

Similar News

48 projects approved to ensure uninterrupted supply of critical APIs

Natco Pharma offers to acquire stake in South African pharma firm Adcock Ingram Holdings for Rs 2000 crore

Syngene International names Chethan Yogesh as Company Secretary, Compliance Officer

Number of schemes being implemented to realise vision of Atmanirbhar Bharat in pharma sector: Minister

Biocon Biologics appoints Deepali Naair as Global Head - Brand & Corporate Communications

Morepen Labs incorporates new step-down subsidiary in mainland Dubai

Biocon Biologics launches Nepexto in Australia

Zydus Secures CDSCO Panel Go-Ahead For Phase III Trial of Empagliflozin-Metoprolol FDC