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Icatibant manufacturers

7 products found

Filters

7 products found

icatibant

Injection, pre-filled syringe 30 mg/3 ml

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Comments
Not available: EU, USA, Australia, Canada, MENA, GCC
Manufacturer #6301
A pharmaceutical manufacturer based in the EU that has been active in 50+ countries selling its products in Europe, MENA, LATAM, and NA for 20+ years. Main therapeutic area include oncology and urology. The company's production lines are GMP-compliant. The main dosage forms includes injectable. The company possesses subsidiaries in LATAM

Manufacturer usually replies in 4 days

icatibant

Injection, pre-filled syringe 10 mg/ml

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Comments
Ref: Firazyr®
Manufacturer #252
This company is a leading player in the pharmaceutical industry, boasting decades of experience in research, development, and manufacturing. They specialize in the production of a wide range of pharmaceutical ingredients (APIs) and finished dosage forms (FDFs) for both human and veterinary use. Their product portfolio spans multiple therapeutic areas, including but not limited to, oncology, cardiology, and other essential therapeutic categories. They offer a comprehensive range of services, including contract manufacturing (CMO) and the production of over-the-counter (OTC) products. The company holds EU and US GMP approvals for its production lines, ensuring adherence to rigorous quality standards. Their production lines encompass various dosage forms, including solids, liquids, and injectables. Their global presence extends across Europe and North America, with a network of 10 manufacturing facilities. They have a strong commitment to research and development, with dedicated teams focusing on innovative solutions and advancements in the pharmaceutical field.

Manufacturer usually replies in 12 days

icatibant

Injection, pre-filled syringe 30 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Unavailable markets
Vietnam
Manufacturer #21467
This global pharmaceutical company is dedicated to improving patients' lives through high-quality, differentiated products and services. They leverage a collaborative network to achieve success in key regions like the EU and North America. Their focus areas include women's health, infectious diseases, and potentially other therapeutic areas based on their recent approvals and launches. They produce prescription medications (including injectables) and tablets, demonstrating expertise in various dosage forms. The company holds GMP certifications and boasts successful product patents, solidifying its commitment to quality and innovation.

Manufacturer usually replies in 12 days

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Icatibant

Icatibant is used in adults with C1-esterase-inhibitor deficiency for the symptomatic treatment of acute attacks of hereditary angioedema. However, Angioedema caused by medication from the ACE inhibitor class is not treated by Icatibant. It has been investigated for treating angioedema, liver disease, and burns and burn infections. Icatibant is classified as a peptidomimetic consisting of ten amino acids, which is a selective and specific antagonist of bradykinin B2 receptors. Icatibant sold under the brand name Firazy among others. Shire plc was given the first FDA approval for its Firazyr in 2011. However, as of 2011, Icatibant has orphan drug status in the United States as per FDA approvals.

Dosage Forms & Strengths

Icatibant is sold as SC injection in a prefilled syringe in 30mg (10 mg/mL). in the treatment of Hereditary Angioedema, the Bradykinin B2 receptor antagonist indicated for the treatment of acute attacks is 3 mL (30 mg) SC in the abdominal area. If the desired response is not achieved from this dose, an injection of 30 mg can be administered at intervals of at least 6 hr, not to exceed 3 injections in 24 hours.

The price of Icatibant

In the USA, the price of generic subcutaneous solution (10 mg/mL) is around $2,950 for a supply of 3 milliliters and the price of Firazyr subcutaneous solution (10 mg/mL) is around $11,647 for a supply of 3 milliliters. The price is much lower in the developing world. In India, the price of one viral is around USD2.5.

How does it work?

Icatibant is a peptide-based hormone, it forms naturally in local tissues in response to trauma. This results in increased vessel permeability blood vessel dilation, and contraction in smooth muscle cells. It is a key mediator of pain and its excess is associated with typical symptoms of inflammation like swelling, redness, overheating, and pain. The resolution of these symptoms is done by activating bradykinin B2 receptors. Icatibant is a bradykinin inhibitor. Its actions block the binding of native bradykinin to the bradykinin B2 receptor, mediating the levels to normal, controlling symptoms of inflammation.

Finding Icatibant Manufacturers and Suppliers

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