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Ivacaftor manufacturers

11 products found

Filters

11 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®
Manufacturer #252

Manufacturer usually replies in 2 days

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 Dossier availability date: Q2 2025
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.

Manufacturer usually replies in 5 days

ivacaftor

Tablets 150 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Dossier availability date: Q2 2025
Manufacturer #519

Manufacturer usually replies in 6 days

ivacaftor

Tablets, film coated 75 mg, 150 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #260
Pharmaceutical manufacturer operating in the EU for 50+ years. Activities include scientific development, manufacturing, out-licensing, marketing, and distribution of high-quality generic medicines. The company owns several production facilities that all comply with EU GMP requirements. Key dosage forms include conventional solids, cytostatic injectables, and cytostatic orals. The company holds an in-house R&D and Intellectual property business unit, as well as a regulatory affairs team that prepares CTD dossiers and maintains direct contact with regulatory agencies worldwide. The portfolio includes more than three thousand MA sets approved in the EU while hundreds of MA are in progress. Key therapy lines are cardiovascular, CNS, diabetes, immunology, oncology, and more. The company is active in nearly 100 countries worldwide, selling its products in Africa, Asia, Australia, Europe, LATAM, and the Middle East.

Manufacturer usually replies in 12 days

ivacaftor

Tablets, film coated 75 mg, 150 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
Iceland
GMP approvals
EU GMP
Manufacturer #28915

Manufacturer usually replies in 14 days

ivacaftor

Granules 25 mg, 50 mg, 75 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
Turkey
GMP approvals
EU GMP
Manufacturer #13095

Manufacturer usually replies in 5 days

ivacaftor + lumacaftor

Tablets, film coated 125mg + 200mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Argentina
GMP approvals
Argentina
Manufacturer #16199
One of the largest and biggest names in the pharmaceutical industry. The company has a network all across the globe. They are known to be partnering with similar companies for a very long time.

Manufacturer usually replies in 9 days

ivacaftor

Tablets, film coated 150mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Argentina
GMP approvals
Argentina
Manufacturer #16199
One of the largest and biggest names in the pharmaceutical industry. The company has a network all across the globe. They are known to be partnering with similar companies for a very long time.

Manufacturer usually replies in 9 days

ivacaftor

Tablets, film coated 150 mg

Dossier type
CTD
Dossier status
Under development
Country of origin
Turkey
GMP approvals
PICS
Manufacturer #13510
It was established in the 2010s. It creates and sells biotech products developed with natural product extracts, helping to improve your heart health, immune system, or mood. It offers the pharmaceutical and nutraceutical industry a natural, science-based therapeutic alternative that can be safely used either in combination with existing medications as add-on ingredients for improved efficacy or presented as a single standing remedy; with patented products, proven benefits, and claims for our natural ingredients in the areas of for example mood improvement, anxiety and stress reduction, eye-health, cardiovascular health advancement and enhancement of the body´s immune system against cold and flu.

Manufacturer usually replies in 6 days

ivacaftor

Tablets 150 mg

Dossier type
CTD
Dossier status
Under development
Country of origin
India
GMP approvals
WHO
Manufacturer #32970

ivacaftor + lumacaftor

Tablets 125 mg + 200 mg

Dossier type
CTD
Dossier status
Under development
Country of origin
India
GMP approvals
WHO
Manufacturer #32970

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.