Suppliers and packagers for generic pharmaceutical drug: ALITRETINOIN

ALITRETINOIN

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Advanz Pharma	PANRETIN	alitretinoin	GEL;TOPICAL	020886	NDA	Advanz Pharma (US) Corp.	59212-601-22	60 g in 1 TUBE (59212-601-22)	2019-09-10

Suppliers and packagers for generic pharmaceutical drug: ALITRETINOIN

Last updated: April 24, 2026

Alitretinoin Suppliers: Drug-Substance and Finished-Dose Supply Landscape

Alitretinoin is a prescription retinoid used for conditions such as chronic hand eczema (in markets where approved). Supply is handled through (1) active pharmaceutical ingredient (API) manufacturers and (2) finished-dose product supply channels (brand and generic). In most countries, “supplier” in practice means one of: API manufacturer, API distributor, finished-dose MAH/importer, or contract manufacturer with market authorization.

Scope note: This response enumerates supplier types and the typical supplier structure for alitretinoin, but it does not list company-by-company tender-ready contacts because no verifiable supplier list (with citations) is provided in the input. Under a strict patent-analysis workflow, supplier identification must be grounded in sourceable records (e.g., regulatory catalogs, INN/API registries, MAH listings, or public procurement awards) to be actionable.

What supplier types cover alitretinoin supply?

Alitretinoin supply typically routes through these nodes:

1. API manufacturers (drug substance)

   • Produce alitretinoin API under GMP.
   • Provide CoA, DMF/ASMF cross-references (where applicable), and specification packages.

2. API distributors / trading houses

   • Source alitretinoin API from API manufacturers.
   • Bundle documentation for customers (CoA, GMP certificates, traceability, often temperature control where needed).

3. Finished-dose manufacturers and packagers

   • Manufacture alitretinoin capsules/tablets and package them to market specifications.
   • Operate under local MAH arrangements or direct marketing authorizations.

4. Marketing authorization holders (MAHs) / importers

   • Hold product authorization for the finished-dose form.
   • Control local supply, labeling, and pharmacovigilance obligations.

5. Contract manufacturing organizations (CMOs)

   • Produce finished doses or intermediates for an MAH/brand.
   • Common when direct marketing authorization holders outsource formulation, fill-finish, or packaging.

What do buyers usually request from an alitretinoin supplier?

A supplier package for alitretinoin is commonly evaluated on documentation, quality, and supply continuity. Typical buyer requirements include:

• Regulatory documentation

  • GMP certificate(s)
  • DMF/ASMF reference (or equivalent dossier access mechanism) for API
  • Finished-dose registration dossier references (by country/region)

• Quality specs

  • Identity, assay, impurity profile, solvent residues
  • Genotoxic impurity controls (if required by local guidelines)
  • Particle size and polymorphic control (if relevant to the solid form)

• Supply and logistics

  • Lead times and batch release timelines
  • Temperature/humidity handling guidance
  • Stability data (ICH conditions) for finished product packaging configuration

• Commercial terms

  • Minimum order quantity (MOQ), packaging format options
  • Forecasting terms and change control obligations
  • Credit terms and delivery Incoterms

Which “supplier” references matter for patent and sourcing strategy?

For R&D or investment decisions, the key is to separate who supplies the molecule from who supplies the dosage form:

• API supplier affects:

  • cost of goods for generics
  • impurity and polymorph profile risk
  • ability to match reference product quality attributes

• Finished-dose supplier/MAH affects:

  • local availability and pricing
  • launch timing for generics or authorized supply
  • label and dosing form alignment with regulatory pathways

How to map alitretinoin suppliers for diligence (without guessing)

A defensible supplier map is built from regulatory and procurement records that identify named entities. The diligence workflow is:

• Step 1: Identify authorized finished products by jurisdiction
  • Extract MAH/importer names and product packager/manufacturer fields.
• Step 2: Link finished products to API sources
  • Use DMF/ASMF cross-references where published in regulatory assessment reports or dossiers.
• Step 3: Validate API manufacturer GMP status
  • Confirm through GMP inspection databases and certificates.
• Step 4: Cross-check supply continuity
  • Use procurement notices, distributor statements, and batch release patterns.

Supplier matrix (template) for alitretinoin

The following table is the structure used to score and compare candidate suppliers in a sourcing strategy. No company names are inserted here because the input does not provide sourceable supplier identities.

Supply node	What to capture	Evidence to cite	Decision value
API manufacturer	GMP site, API grade, specs, impurity profile	GMP certificate + regulatory filing references	Controls COGS and quality risk
API distributor	Source manufacturer, documentation package, lead time	Distributor statements + CoA history	Controls procurement agility
Finished-dose manufacturer	Formulation/manufacturing site(s), packaging	MAH product dossier fields	Controls bioequivalence and batch consistency
MAH/importer	Country-specific authorization	Local regulatory register	Controls market access and availability
CMO/packager	Fill-finish, packaging compliance	GMP/quality agreements	Controls capacity scaling

What usually constrains alitretinoin supply?

Alitretinoin supply constraints typically come from:

• limited number of API manufacturing sites that can maintain GMP for this specific retinoid
• impurity control challenges for sensitive retinoids (affects batch release)
• regulatory and operational complexity for finished-dose manufacturing and packaging
• market concentration where fewer MAHs dominate local availability

Key Takeaways

• Alitretinoin supply is handled through API manufacturers, API distributors, finished-dose manufacturers/packagers, and MAHs/importers.
• For actionable sourcing, supplier identity must come from jurisdictional regulatory registers, GMP records, and dossier cross-references, not from generic listings.
• The buyer’s diligence focus is on GMP evidence, impurity/spec compliance, documentation linkage (DMF/ASMF), and supply continuity by site.

FAQs

1. Who is considered the “supplier” for alitretinoin in procurement documents?
   Often either the API manufacturer (if buying raw material) or the MAH/importer/manufacturer listed in the finished-dose regulatory registration (if buying capsules/tablets).

2. What documentation should an alitretinoin API supplier provide?
   A GMP certificate for the manufacturing site and a complete CoA/specification package, ideally linked to DMF/ASMF references when applicable.

3. Is it enough to find any alitretinoin API vendor?
   No. Buyers typically require impurity profile alignment, release specifications, and documentation traceability to avoid batch release failures.

4. How do finished-dose suppliers affect bioequivalence risk?
   Finished-dose manufacturing site, formulation process, and packaging configuration can shift critical quality attributes that influence dissolution and in vivo performance.

5. What is the fastest way to build an evidence-backed supplier shortlist for alitretinoin?
   Use jurisdictional product registers to identify MAHs/importers, then map those to manufacturing sites and regulatory dossier references for the API.

References

[1] European Medicines Agency (EMA). European public assessment reports (EPAR) for relevant alitretinoin products.
[2] FDA. Drug product labeling database and regulatory information for alitretinoin (where applicable).
[3] WHO. INN (International Nonproprietary Names) portal for “alitretinoin.”
[4] EudraGMDP / EudraGMP. GMP database and inspection-related public information (where available).