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Ivacaftor manufacturers

19 products found

Filters

19 products found

ivacaftor

Tablets, film coated 150 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Ref. Kalydeco® Vertex
Manufacturer #8822
A pharmaceutical manufacturer based in Europe that has been active in 60+ countries selling its products in Europe, North America, LATAM, MENA, and Asia for 50+ years. The main therapeutic areas include CNS, ophthalmology, and dermatology. Main dosage forms include sterile and solid oral dosage forms. The company's production lines are cGMP-compliant. The company possesses branches in Europe, North America, and Asia.

ivacaftor

Tablets, film coated 150 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Ref: Kalydeco®
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 1 days

ivacaftor

Tablets 150 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #519
This pharmaceutical company is a leading manufacturer and exporter with operations spanning over 160 countries, specializing in the development, production, and sale of high-quality generic pharmaceuticals for human use. They have a strong track record of success, having received numerous awards and distinctions including the "European Award for Best Practices" . The company's extensive product portfolio encompasses a wide range of dosage forms and therapy areas, with specific details on these areas, forms, GMP certifications, and patents not provided in the text. Their focus extends beyond prescription medications to include over-the-counter drugs and potentially medical devices or supplements as well.

Manufacturer usually replies in 2 days

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Ivacaftor Manufacturers

Markets of interest

Ivacaftor is used for the management of Cystic Fibrosis (CF) in adults and children who are at least 4 months old and weigh at least 11 pounds (5 kilograms). The substance is for use only in patients with a specific gene mutation related to cystic fibrosis. Before you take ivacaftor, you may need a medical test to make sure you have this gene mutation. The drug is available for sale in the form of tablets, tablets, film-coated, from manufacturers in various countries including Y. The drug is provided by a wide range of Ivacaftor suppliers from various countries including the Y, Y, and Y. Mostly due to the availability of raw materials for the manufacturing process and low labor costs, the leading Ivacaftor manufacturers and distributors are based in India and Argentina.

Licensing and brand names

In 2012, the medication was approved by the FDA in the United States. Ivacaftor is administered as a monotherapy and also administered in combination with other drugs for the management of Cystic Fibrosis. The medication is presently approved in many countries and is available in both generic and trade name versions. The medication is marketed under the trade names including Kalydeco. One of the most popular branded versions of Ivacaftor is manufactured and supplied by the Indian pharmaceutical company MSN Labs. Other manufacturing companies and distributors from European Union, Bosnia and Herzegovina, Canada, Ukraine, Israel have also successfully adapted to the demands of the global marketplace and produce a variant of the drug with Ivacaftor as an active ingredient.

Target supply price

The wholesale acquisition cost for Kalydeco oral tablet 150 mg is around $24,957 for a supply of 56 tablets. The retail price of the same amount of the substance in Europe reaches 17 EUR. The medication wholesale prices and commercial terms can vary depending on the supplier. The medication wholesale prices and commercial terms can vary depending on the supplier.

Information from manufacturers

We provide a detailed list of the Ivacaftor manufacturers and suppliers that you are looking for. You can also find the dossier status of Ivacaftor and the GMP approvals of the different variants of the medication. The product description of all Ivacaftor suppliers contains essential information about the medication you order including clinical data, stability zones, and a list of countries where Ivacaftor is already registered in. Manufacturers also specify the commercial terms of their offers, such as the market for which the offer is intended, deal type, dossier licensing fee, supply price, payment terms as well as delivery terms. Buyers are advised that online sellers may attempt to market fraudulent versions of the generic drug, whereas Pipeline Pharma, through its pre-auditing and quality control procedures ensures that only verified Follicle-stimulating hormone suppliers and distributors enter our online marketplace, offering you a risk-free global B2B pharmaceutical sales platform.

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