Last updated: May 26, 2026
Major suppliers for the active ingredients used in CFTR modulator regimens (deutivacaftor, tezacaftor, and vaza-caftor calcium) are concentrated in a small set of global fine-chemical and CMO networks that support high-potency, multi-step synthesis and low-ppm impurity control. However, no complete, verified supplier list by brand-to-API mapping is provided in the supplied input, and a definitive “who supplies whom” roster cannot be produced without Orange Book linked manufacturer disclosures, drug master file references, or procurement records.
Which companies supply deutivacaftor (API) for CFTR modulator combinations?
Direct answer: No verified supplier list for deutivacaftor can be stated from the provided information.
What supply models typically exist for deutivacaftor
- API manufacture through fine-chemical synthesis routes with dedicated HPAPI containment.
- API downstream step to isolate the final active form with impurity specifications.
- Salt/form confirmation and analytical release (for downstream formulation supply).
What to search to identify deutivacaftor API sources
- DMF holder names tied to CFTR modulator submissions (where referenced).
- Contract manufacturing organizations named on finished-dose labeling and regulatory filings.
- Public procurement awards for CFTR modulator APIs (limited coverage).
Which companies supply tezacaftor (API) for ivacaftor and tezacaftor regimens?
Direct answer: No verified supplier list for tezacaftor can be stated from the provided information.
How tezacaftor supply chains are usually structured
- Multistage intermediate chemistry and chiral or complex ring assembly (route dependent).
- Robust impurity control and stability-indicating method package.
- Cold-chain is not typically required for API, but temperature excursions and moisture control can be critical for certain intermediates.
What to search to identify tezacaftor API sources
- Orange Book “Applicant/Manufacturer” relationships for finished product.
- DMF/CEP references used by generic applicants (if any) and by brand renewals.
- CMO announcements tied to high-potency APIs.
Which companies supply vaza caftor calcium (API) for triple-combination CFTR therapy?
Direct answer: No verified supplier list for vaza-caftor calcium can be stated from the provided information.
Why the calcium form matters for supplier qualification
- Salt form dictates polymorph/solvate risk and analytical release strategy.
- Particle size distribution, crystallinity, and moisture interaction affect downstream tablet performance and stability.
What to search to identify vaza-caftor calcium API sources
- DMF holders referencing the calcium form and specification controls.
- Finished-dose tablet/capsule labeling manufacturing sites that indicate API supply partners indirectly.
- Regulatory filings that cite the salt form and manufacturer of record.
Do DEUTIVACAFTOR, TEZACAFTOR, and VANZACAFTOR CALCIUM come from the same supplier network?
Direct answer: No verified cross-supplier mapping can be stated from the provided information.
Common pattern in CFTR modulator supply
- Finished product is often manufactured by one or more CMOs, while APIs are sourced through specialized intermediates suppliers plus a small number of final API makers.
- Even when intermediates overlap, final API step and salt confirmation can be performed by different suppliers.
How many qualified suppliers exist for these CFTR modulator APIs, and what is the concentration risk?
Direct answer: No verified count can be provided from the provided information.
What concentration typically looks like in practice
- High-potency oral small molecules tend to have a limited number of qualification-ready suppliers due to containment, testing, and route complexity.
- Supply continuity risk is driven by intermediate availability and specialized purification equipment.
What contract manufacturing capabilities are required to formulate these CFTR modulators?
Direct answer: No verified CMO capability map can be stated from the provided information.
Typical qualification requirements (formulation)
- HPAPI handling with validated cross-contamination controls.
- Blend and tablet tooling compatible with low-dose actives and controlled dissolution profile.
- Stability studies for multi-month accelerated and long-term conditions, with monitoring of impurities.
Typical qualification requirements (packaging and release testing)
- Moisture barrier packaging and protective desiccant strategy where needed.
- Robust dissolution and impurity methods aligned with regulatory expectations for CFTR modulators.
What are the regulatory “supplier proof” artifacts used to validate API sources?
Direct answer: No verified supplier proof artifacts for these specific actives can be listed from the provided information.
Regulatory documents that usually disclose supply-linked identities
- DMFs (API and sometimes key intermediates), including holder/manufacturer name.
- Drug product application manufacturing sites and applicant cross-references.
- Comparability protocols for process changes by API makers.
Key takeaways
- A definitive, verified supplier list for deutivacaftor, tezacaftor, and vaza-caftor calcium cannot be produced from the provided input.
- Supplier identification for these CFTR modulators typically requires linking finished product applicant/manufacturer records to DMF holders and manufacturing sites in regulatory submissions.
- Salt form specificity (vaza-caftor calcium) increases qualification burden and narrows the pool of viable API suppliers.
FAQs
- How do I identify the API DMF holder for tezacaftor in FDA submissions?
- What quality attributes matter most for vaza-caftor calcium salt form supply?
- Which manufacturing sites are typically responsible for CFTR modulator finished-dose production?
- What documents show API supplier changes for CFTR modulators?
- How does API impurity control drive supplier qualification for high-potency CFTR modulators?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (U.S. FDA database).
- FDA. Drug Master Files (DMF) guidance and DMF information resources. (U.S. FDA).
