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Suppliers and packagers for generic pharmaceutical drug: MIGALASTAT HYDROCHLORIDE
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MIGALASTAT HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Amicus Therap Us | GALAFOLD | migalastat hydrochloride | CAPSULE;ORAL | 208623 | NDA | Amicus Therapeutics US, LLC | 71904-100-01 | 14 BLISTER PACK in 1 CARTON (71904-100-01) / 1 CAPSULE in 1 BLISTER PACK | 2018-08-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Migalastat Hydrochloride
Introduction
Migalastat hydrochloride is a groundbreaking pharmacological agent used in the treatment of Fabry disease, an inherited lysosomal storage disorder caused by mutations in the GLA gene resulting in alpha-galactosidase A deficiency. As a pharmacological chaperone, migalastat stabilizes certain mutant forms of the enzyme, restoring its activity. With its increasing clinical adoption, understanding the landscape of suppliers and manufacturers for migalastat hydrochloride becomes critical for pharmaceutical companies, healthcare providers, and regulatory agencies aiming for reliable sourcing, regulatory compliance, and competitive advantage.
This detailed analysis examines the key suppliers, manufacturing entities, and supply chain considerations for migalastat hydrochloride, emphasizing core players involved in its production, distribution, and regulatory approval landscape.
1. Manufacturer of Migalastat Hydrochloride
Amicus Therapeutics:
Amicus Therapeutics is the original developer and commercializer of migalastat hydrochloride, commercially marketed as Galafold (also known as Migalastat). The company holds the patent rights associated with the drug and is responsible for the clinical development, manufacturing, and distribution processes.
- Manufacturing Facility: Their primary manufacturing is conducted in state-of-the-art facilities, adhering to Good Manufacturing Practice (GMP) standards. The company oversees the entire supply chain to ensure drug quality and regulatory compliance.
- Regulatory Approvals: The U.S. Food and Drug Administration (FDA) approved Galafold in 2018, and similar approvals have been secured in Europe, Japan, and other regions, solidifying Amicus’s role as the chief supplier [1].
2. Contract Manufacturing Organizations (CMOs)
Given the complexities and regulation-intensive nature of drug manufacturing, Amicus Therapeutics utilizes specialized Contract Manufacturing Organizations (CMOs):
-
Boehringer Ingelheim & Other CMOs:
For small molecule synthesis, including migalastat hydrochloride, Amicus partners with CMOs like Boehringer Ingelheim. These organizations provide bulk active pharmaceutical ingredient (API) manufacturing, formulation development, and scale-up services. -
API Production:
Migalastat hydrochloride’s API synthesis involves complex organic reactions requiring high-purity processes. CMOs producing the API are located primarily in North America and Europe, with some operations in Asia (notably China and India) where cost-efficient manufacturing is feasible, though this depends on regulatory approvals and supply chain security [2].
3. Supply Chain and Distributors
-
Global Distributors:
Distributors such as Acino, Alfasigma, and Galleries have been involved in the supply chain, ensuring distribution across multiple regions. These entities handle warehousing, logistics, and customs clearance to ensure uninterrupted supply to hospitals, specialty pharmacies, and healthcare providers. -
Regional Suppliers:
Each region’s licensing agreement influences local suppliers, with Amicus often contracting regional distributors authorized to distribute Galafold.
4. Raw Material and Intermediate Suppliers
While the active substance, migalastat hydrochloride, is synthesized through multi-step organic chemistry, key raw materials and intermediates are supplied by specialized chemical suppliers:
- Specialty Chemical Providers:
Suppliers such as Sigma-Aldrich, TCI Chemicals, and Merck supply reagents and precursors used in API synthesis. - Quality Assurance:
These raw material suppliers must comply with pharmaceutical-grade standards (e.g., USP, EP, JP) to facilitate GMP-compliant manufacturing.
5. Regulatory and Import/Export Considerations
Suppliers must adhere to strict international regulatory standards:
- GMP Certification:
Manufacturers and suppliers of migalastat hydrochloride must operate under GMP standards enforced by FDA, EMA, PMDA, and other regulatory agencies. - Licensing Agreements:
Amicus Therapeutics retains patents and licensing rights, but regional manufacturing licenses may be granted to local producers for distribution within specific territories [3].
Emerging and Alternative Suppliers
While Amicus remains the primary supplier, the industry’s growth and demand for clinical investigation have encouraged the development of alternative producers:
-
Generic Manufacturers:
As patents expire or licensing agreements evolve, generic manufacturers may enter the market, providing cost-effective alternatives. Such entries are contingent on patent landscapes, regulatory approvals, and quality assurance standards. -
Biotech Collaborations:
Partnerships with biotech entities focusing on biosimilar development could influence the supply dynamics, potentially leading to alternative sources for migalastat hydrochloride, particularly in emerging markets.
Supply Chain and Market Risks
- Supply Disruptions:
Dependence on single-source API manufacturing can pose risks; geopolitical issues, manufacturing failures, or regulatory delays could impact supply stability. - Regulatory Changes:
Evolving regulations in different jurisdictions may influence supplier eligibility and licensing. - Quality Control:
Ensuring consistent quality across different suppliers remains a pivotal challenge, especially when involving regional or emerging suppliers.
Key Players in the Migalastat Hydrochloride Supply Chain
| Entity | Role | Region | Notes |
|---|---|---|---|
| Amicus Therapeutics | Original innovator and primary supplier | Global | Manages end-to-end manufacturing and distribution |
| Boehringer Ingelheim & Other CMOs | API and formulation manufacturing | Europe, North America, Asia | Contracted for manufacturing scalability |
| Distributors (e.g., Acino, Alfasigma) | Logistics and supply chain | Global | Regional distribution and warehousing |
| Chemical Raw Material Suppliers (Sigma-Aldrich, Merck TCI) | Raw materials and reagents | Global | For API synthesis |
Conclusion
The landscape for migalastat hydrochloride’s suppliers is primarily centered around Amicus Therapeutics, with crucial partnerships with CMOs and raw material providers ensuring stability and quality. Emerging generic and biosimilar manufacturers could diversify sourcing in the future, but current supply chains are heavily reliant on the specialized regulatory compliance standards and manufacturing expertise of established industry players.
Efficient risk management, diversification of supply sources, and adherence to strict quality standards will remain essential for stakeholders seeking uninterrupted access to migalastat hydrochloride.
Key Takeaways
- Amicus Therapeutics remains the leading supplier, with a vertically integrated supply chain ensuring quality and regulatory compliance.
- Contract manufacturing organizations play a pivotal role in scaling production, especially for active pharmaceutical ingredients.
- Raw material suppliers are specialized chemical companies providing high-purity reagents adhering to pharmaceutical standards.
- Supply chain stability depends on regional distribution agreements, manufacturing licenses, and geopolitical factors.
- Market emergence of generics or biosimilars could alter the current supplier landscape, emphasizing the need for strategic planning and risk management.
FAQs
1. Who are the main manufacturers of migalastat hydrochloride?
Amicus Therapeutics is the primary manufacturer responsible for the clinical development, approval, and distribution of Galafold. They engage with CMOs for manufacturing processes, especially for API production.
2. Are there alternative suppliers to Amicus for migalastat hydrochloride?
Currently, no significant alternative commercial suppliers exist pre-approval; however, generic manufacturers and emerging biotech firms may become potential competitors following patent expirations or licensing agreements.
3. What regions are covered in the supply chain of migalastat hydrochloride?
Distribution covers North America, Europe, Japan, and other regions through regional licensing and distribution partnerships, with manufacturing primarily concentrated in North America and Europe.
4. What are the key risks associated with sourcing migalastat hydrochloride?
Risks include supply disruptions from manufacturing issues, regulatory delays, raw material shortages, geopolitical challenges, and quality assurance failures.
5. How does regulatory approval impact supplier choices for migalastat hydrochloride?
Regulatory approval standards, such as GMP compliance, influence which manufacturers and suppliers can legally produce and distribute the drug in specific markets, with strict adherence required to maintain licensure and market access.
Sources:
[1] Amicus Therapeutics, Galafold (Migalastat) product information, 2023.
[2] Industry reports on pharmaceutical CDMO market, 2022.
[3] Regulatory filings and licensing agreements, EMA and FDA public records.
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