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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 and packagers for generic pharmaceutical drug: MIGALASTAT HYDROCHLORIDE
Migalastat Hydrochloride Suppliers: Who Manufactures Bulk Drug Substance and Finished Capsules?
Migalastat hydrochloride is supplied through a small set of specialized APIs and finished-dose manufacturing networks tied to the commercialization of Galafold (migalastat) by Amicus Therapeutics. Supplier availability typically depends on licensing for the active pharmaceutical ingredient (API) and capsule manufacturing, plus quality system qualification for migalastat stability and control of hydrochloride form-specification.
Who supplies migalastat hydrochloride (API) for generic or contract manufacturing?
The practical supplier landscape for migalastat hydrochloride is constrained by licensing and downstream qualification because migalastat is a niche orphan drug active with limited commercial scale.
Key supply channels
- Licensed API suppliers producing migalastat hydrochloride drug substance under commercial or R&D supply agreements with the brand owner and/or its authorized manufacturers.
- Contract development and manufacturing organizations (CDMOs) that receive qualified migalastat hydrochloride API and produce capsules under current good manufacturing practice (cGMP).
- Program-specific sourcing for clinical or regulatory filings, often limited to the same controlled network used by the brand for stability-indicating analytics and form control.
Commercial bottlenecks
- Migalastat hydrochloride is a specialty API where supply is typically managed through prequalified vendors to maintain polymorph/solvate controls and impurity profiles.
- Finished-dose supply relies on capsule formulation know-how and validated analytical methods tied to the brand’s specifications.
What companies manufacture migalastat hydrochloride under Galafold (migalastat) supply chains?
Amicus Therapeutics markets Galafold (migalastat) and ties commercial supply to qualified manufacturers for drug substance and finished product.
What to look for in practice
- Authorized manufacturing names on FDA drug approvals, annual reports, and manufacturing site disclosures.
- Quality agreements indicating who is the actual site producing API versus a repackager or analytics provider.
- Consistency across lots for impurity controls and dissolution behavior in capsules.
Because supplier identification requires exact manufacturing site attribution tied to FDA submissions, internal supplier lists, and authorization scope, producing a firm, named supplier list without those records would risk inaccuracy.
Which contract manufacturers (CDMOs) can produce migalastat hydrochloride capsules?
In the migalastat context, capsule manufacturing is the typical dosage form pathway for brand and likely generics, but CDMO eligibility is limited by:
- experience with niche, low-volume orphan APIs
- validated methods for hydrochloride salt form control
- ability to meet capsule-specific dissolution specifications
- ability to run stability programs aligned to migalastat degradation behavior
Common CDMO requirements
- cGMP capsule filling and finishing
- analytical capacity for migalastat impurity panel control
- validated stability-indicating assays and dissolution methods
- tech transfer support for formulation and process controls
Named CDMO site-to-drug matching depends on confirmed manufacturing authorizations and technical transfer history.
What is the difference between migalastat hydrochloride API suppliers and branded finished-product manufacturers?
API suppliers
- Manufacture migalastat hydrochloride drug substance.
- Supply is gated by impurity control and salt-form specification.
- API qualification is tied to established reference standards and analytical method equivalence.
Finished-product manufacturers
- Formulate and encapsulate migalastat using the qualified API.
- Validate dissolution, uniformity, and stability for capsules.
- Operate under a site-level dossier footprint that supports FDA release specs.
This separation matters for procurement: an API vendor may exist, but a different vendor may be required to produce capsules under a specific regulatory filing or NDA/ANDA.
What is the Orange Book and FDA pathway implication for supplier sourcing of migalastat?
Migalastat’s continued exclusivity and patent landscape impacts:
- whether generic supply chains can source compatible API with the same impurity profile targets
- whether Paragraph IV challenges or licensing deals require reliance on specific authorized suppliers
Supplier discovery for generics generally hinges on:
- whether the ANDA references the reference listed drug and obtains compatibility for bioequivalence
- whether any litigation or settlement restricts launch timing and therefore supply commitments
When do migalastat supply constraints ease, and how does that affect available suppliers?
Supplier expansion typically correlates with:
- product exclusivity timelines
- resolution of ANDA and patent disputes
- CDMO capacity commitments once regulatory pathways clear
When launch windows open, procurement shifts toward:
- additional qualified API sources
- multiple CDMOs to reduce schedule risk
However, precise timing for migalastat requires confirmed exclusivity and patent expiration calendars from FDA and Orange Book listings. Without those dates, presenting a reliable supplier-timing view would be speculative.
What generic entry risks change the migalastat hydrochloride supplier list?
Generic and authorized alternatives can alter supplier availability through:
- process equivalence requirements for drug substance quality
- impurity specification tightness driven by reference product analytics
- licensing restrictions if formulation or process IP is involved
- the need for regulatory-grade residual solvent and impurity management
In niche orphan drugs, even when legal barriers fall, supplier onboarding can lag because of:
- analytical method transfer time
- stability program burden
- capsule formulation process qualification
How does migalastat hydrochloride supplier diversity compare with other rare-disease orals?
Rare-disease oral suppliers typically show a concentrated network:
- fewer API producers
- 1 to 2 capsule manufacturing sites supporting commercial scale
- additional capacity appearing only after regulatory clearance
Migalastat fits that pattern because of limited global demand relative to large-market generics.
Key Takeaways
- Migalastat hydrochloride supply is concentrated and tied to qualified, authorized manufacturing networks supporting Galafold commercialization.
- API sourcing is typically separate from capsule manufacturing, and both require strict impurity and salt-form controls.
- Supplier diversification usually tracks regulatory and patent clearance rather than immediate market procurement demand.
- Exact supplier names and sites should be drawn from confirmed FDA manufacturing authorization records and reference product dossiers to avoid misattribution.
FAQs
- Can migalastat hydrochloride be sourced from multiple API vendors without changing impurity profiles?
- What quality system controls are most critical for migalastat hydrochloride salt-form consistency?
- How do capsule dissolution specifications affect CDMO selection for migalastat generics?
- Do Paragraph IV challenges typically require specific API sourcing strategies for migalastat?
- What documentation supports regulatory qualification of a new migalastat hydrochloride API supplier?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026).
- FDA. Drug Approval Package for Galafold (migalastat). (Accessed 2026).
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