Latest news with #CaplinSteriles
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 Standard
23-04-2025
- Health
- Business Standard
Caplin Steriles receives USFDA approval for Phytonadione Injectable Emulsion
Caplin Point Laboratories announced 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) Phytonadione Injectable Emulsion USP, 10 mg/mL, Single Dose Vial, a generic therapeutic equivalent version of the Reference Listed Drug (RLD) VITAMIN K1 Injection, from Hospira Inc. Phytonadione Injectable Emulsion possesses the same type and degree of activity as does naturally-occurring vitamin K and is indicated for coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. According to IQVIATM (IMS Health), Phytonadione Injectable Emulsion had US sales of approximately $18.5 million for the 12-month period ending February 2025.
Business Standard
23-04-2025
- Business
- Business Standard
Caplin Point Lab arm receives final approval for Phytonadione Injectable Emulsion
Caplin Point Laboratories announced that its subsidiary, Caplin Steriles, has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Phytonadione Injectable Emulsion USP, 10 mg. The approved product is a generic therapeutic equivalent of the Reference Listed Drug (RLD), VITAMIN K1 Injection, manufactured by Hospira Inc. Phytonadione Injectable Emulsion, a synthetic form of vitamin K, is used to treat bleeding and clotting disorders caused by vitamin K deficiency, certain medications such as warfarin, or medical conditions like obstructive jaundice and ulcerative colitis. It is effective in correcting coagulation disorders resulting from impaired synthesis of clotting factors II, VII, IX, and X. According to IQVIA, Phytonadione Injectable Emulsion USP, 10 mg, has an estimated U.S. market size of $18.5 million for the twelve months ending February 2025. Caplin Point Laboratories is a fast-growing 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. Shares of Caplin Point Laboratories rose 0.03% to Rs 1,890.65 on the BSE.
