Ivacaftor tablet bulk supplier for pharma manufacturers

Ivacaftor Tablet 150 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 150 mg

Reference Brands: Kalydeco®(US & EU)

Ivacaftor tablets enhance cystic fibrosis treatment by acting as a CFTR potentiator, increasing the activity of the defective CFTR protein caused by specific mutations. Benefits include improved lung function, better mucus clearance, and overall quality of life, making it a targeted therapy for eligible cystic fibrosis patients.

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Product Description: Ivacaftor tablets, marketed as Kalydeco®, are approved for cystic fibrosis treatment in the US and EU. Regulatory agencies like the FDA and EMA reviewed extensive clinical data and manufacturing dossiers for approval, ensuring safety, efficacy, and quality. These dossiers contain detailed information on clinical trials, pharmacology, and manufacturing practices. Kalydeco® is available in 150 mg tablets, offering targeted therapy for specific CF mutations. For expert insights on regulatory processes, dossier submissions, and market approvals, visit PharmaTradz, your trusted source for pharmaceutical regulatory updates and industry analysis.

Ivacaftor Tablet — third party manufacturing & bulk supply

Ivacaftor Tablet 150 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Ivacaftor Tablet is supplied as Tablets — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Ivacaftor Tablet listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Ivacaftor tablet is listed as Tablets in 150 mg. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Ivacaftor tablet is referenced against Kalydeco®(US & EU). Reference brands are shown for identification only and remain the property of their respective trademark owners.