deutivacaftor; tezacaftor; vanzacaftor calcium: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730	NDA	Vertex Pharmaceuticals Incorporated	51167-121-01	4 BLISTER PACK in 1 CARTON (51167-121-01) / 14 TABLET, FILM COATED in 1 BLISTER PACK	2024-12-20
Vertex Pharms Inc	ALYFTREK	deutivacaftor; tezacaftor; vanzacaftor calcium	TABLET;ORAL	218730	NDA	Vertex Pharmaceuticals Incorporated	51167-135-01	4 BLISTER PACK in 1 CARTON (51167-135-01) / 21 TABLET, FILM COATED in 1 BLISTER PACK	2024-12-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

The landscape of pharmaceutical supply chains is intricate and vital, especially for drugs targeting rare and chronic diseases like cystic fibrosis (CF). Deutivacaftor, tezacaftor, and vanzacaftor calcium are key components of innovative CF therapies, notably in combination formulations such as Symdeko® and Trikafta®. Ensuring a reliable, compliant, and high-quality supply for these active pharmaceutical ingredients (APIs) is critical for manufacturers, healthcare providers, and patients. This report evaluates current suppliers, key manufacturing considerations, and strategic implications for these compounds.

Understanding the Pharmaceutical Agents

Deutivacaftor: An investigational or specialized CFTR modulator potentially related to ivacaftor, designed to improve CFTR protein function in cystic fibrosis. Its development and commercialization are often tied to elite pharmaceutical collaborations.

Tezacaftor: A CFTR corrector approved by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), primarily marketed within Symdeko®, which treats certain CF mutations by enhancing CFTR protein processing.

Vanzacaftor Calcium: A CFTR corrector similar in function to tezacaftor, potentially under development or in limited distribution channels. Its supply chain is less publicly documented but remains critical for combination therapies.

Primary Suppliers and Manufacturing Sources

1. Tezacaftor

As a marketed drug, tezacaftor's supply comes predominantly from highly regulated, large-scale pharmaceutical manufacturers.

Vertex Pharmaceuticals: Initially developed tezacaftor in conjunction with collaborations like Johnson & Johnson (Janssen Pharmaceuticals). Vertex has been a central player in manufacturing and supplying tezacaftor for commercial use, leveraging in-house GMP (Good Manufacturing Practice) facilities.
Contract Manufacturing Organizations (CMOs): Several CMOs with specialized expertise in complex small-molecule synthesis manufacture tezacaftor under Vertex’s specifications. Examples include Oncologie, Catalent, and AstraZeneca’s contract facilities.
API Synthesis: The synthesis involves asymmetric hydrogenation and chiral purification, conducted in facilities compliant with ISO 13485 and ICH Q7 guidelines.

2. Vanzacaftor Calcium

Being less established compared to tezacaftor, the supply landscape for vanzacaftor calcium remains emerging.

Research and Development Suppliers: Some bio-pharmaceutical companies or biotech firms engaged in CF research may develop or produce vanzacaftor under licensing agreements to specialty CMOs.
Contract Manufacturers: Likely small-to-medium biotech APIs or CDMOs (Contract Development and Manufacturing Organizations) with expertise in CFTR correctors, such as Liomont, GH Labs, or specialized API manufacturers in India and China.
Limited Public Data: Confidentiality agreements and patent protections restrict transparent identification of specific suppliers for vanzacaftor calcium, but industry indications suggest sourcing from established API hubs.

3. Deutivacaftor

Development Stage & Suppliers: As a newer or investigative agent, deutivacaftor’s manufacturing partners are primarily biotech firms focused on CFTR modulator development. Companies like AbbVie, Genentech, or Novartis could potentially serve as suppliers if invested in this molecule.
OEM & CDMO Partners: Development-stage molecules are often outsourced to CDMOs such as Lonza, Synthon, or Fujifilm Diosynth for initial synthesis, scale-up, and eventual GMP manufacturing.

Key Supplier Regions and Considerations

North America: Dominates API manufacturing due to strict regulatory oversight, high GMP standards, and advanced R&D infrastructure. Vertex’s manufacturing facilities are primarily based here.
Europe: Hosts European-based CMOs and API producers with comparable quality standards, contributing to supply diversification.
Asia-Pacific: Countries like India and China are significant sources due to cost advantages, high-volume capacity, and expanding API manufacturing capabilities. However, supply chain risks (e.g., quality variability, geopolitical issues) warrant careful assessment.

Regulatory and Quality Assurance

Suppliers for CFTR modulators like tezacaftor and vanzacaftor calcium must meet stringent global standards:

GMP Certification: Ensures consistent quality and safety.
EMA and FDA Approval: Suppliers involved in commercial supply must adhere to regulatory specifications specific to markets.
Supply Chain Integrity: Ensuring traceability, risk mitigation, and compliance involve rigorous audits and supplier qualification programs.

Strategic Supply Chain Implications

Diversification: Relying on multiple qualified suppliers mitigates risks related to production disruptions, regulatory delays, or geopolitical issues.
Quality & Compliance: Vigilant oversight of supplier quality is critical for sensitive drugs with complex synthesis processes.
Partnerships & Licensing: Companies developing vanzacaftor or deutivacaftor can consider strategic alliances with established CMOs during early development phases to secure reliable supply.

Conclusion

The supply landscape for deutivacaftor, tezacaftor, and vanzacaftor calcium is characterized by a mix of in-house manufacturing, strategic alliances, and contracted development with regional CMOs. Tezacaftor benefits from a well-established supplier base, primarily driven by Vertex and large CMOs in North America and Europe. Vanzacaftor calcium and deutivacaftor, being more recent or investigational compounds, depend heavily on specialized biotech manufacturers and CDMOs, with source locations spanning North America, Europe, and Asia-Pacific.

An effective supply chain strategy mandates ongoing supplier qualification, diversification, and compliance vigilance to sustain manufacturing continuity for pivotal CF therapies.

Key Takeaways

Reliable supplies for tezacaftor stem from Vertex’s manufacturing facilities and established CMOs.
Vanzacaftor calcium and deutivacaftor sourcing are emerging, with suppliers predominantly in biotech and CDMO sectors in North America, Europe, and Asia.
Global supply chain resilience depends on diversification across regions and rigorous quality assurance protocols.
Strategic partnerships with experienced API manufacturers are essential during development and commercialization stages.
Regulatory compliance, traceability, and transparent sourcing underpin supply chain integrity for critical CF medications.

FAQs

Q1: Who are the main suppliers of tezacaftor for commercial use?
A1: Vertex Pharmaceuticals, in collaboration with large CMOs like Catalent and AstraZeneca facilities, serve as primary suppliers for tezacaftor.

Q2: Are there alternative sources for vanzacaftor calcium?
A2: While limited public data exists, emerging biotech firms and regional API manufacturers in Asia are potential sources, with supply contingent on licensing and development status.

Q3: What regulatory standards do suppliers for these drugs need to meet?
A3: Suppliers must comply with GMP, FDA, and EMA standards, ensuring quality, safety, and traceability in all manufacturing processes.

Q4: How does supply chain diversification benefit CF drug manufacturers?
A4: Diversification reduces risks related to supply disruptions, maintains manufacturing continuity, and ensures stable drug availability to patients.

Q5: What considerations are critical when selecting a CDMO for CFTR modulators?
A5: Experience in complex small-molecule synthesis, GMP compliance, regulatory track record, capacity, and quality assurance systems are key selection criteria.

Sources: [1] U.S. Food and Drug Administration, “Trikafta (elexacaftor, tezacaftor, ivacaftor)”, 2019.
[2] European Medicines Agency, “Symdeko (tezacaftor/ivacaftor)”, 2018.
[3] Vertex Pharmaceuticals, corporate disclosures and pipeline updates.
[4] Industry reports on API manufacturing, Contract Manufacturing Organization capabilities.

Suppliers and packagers for generic pharmaceutical drug: deutivacaftor; tezacaftor; vanzacaftor calcium