Latest news with #HALDOL
Business Standard
14-05-2025
- Business
- Business Standard
Caplin Steriles receives USFDA approval for Haloperidol Decanoate Injection
Caplin Steriles (Caplin), a Subsidiary Company of Caplin Point Laboratories, has been granted 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, 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 IQVIATM (IMS Health), Haloperidol Decanoate Injection had US sales of approximately $16.4 million for the 12 month period ending March 2025.
Business Standard
14-05-2025
- Business
- Business Standard
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.
Business Upturn
14-05-2025
- Business
- Business Upturn
Caplin Point Laboratories subsidiary receives USFDA approval for Haloperidol Decanoate Injection
Caplin Steriles Limited, a subsidiary 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) for Haloperidol Decanoate Injection. The approved product will be available in strengths of 50 mg/mL and 100 mg/mL in single-dose vials and 500 mg/5 mL (100 mg/mL) in multiple-dose vials. The approved injection is a generic version of the Reference Listed Drug (RLD), HALDOL (haloperidol decanoate), originally developed by Janssen Pharmaceuticals Inc. It is indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy. According to data from IQVIA (formerly IMS Health), Haloperidol Decanoate Injection recorded sales of approximately USD 16.4 million in the United States for the 12-month period ending March 2025. Caplin Steriles' approval for this product allows it to enter the U.S. market for long-acting injectable antipsychotic treatments, offering a therapeutic alternative for healthcare providers managing chronic schizophrenia cases. Caplin Point Laboratories Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
