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Suppliers and packagers for generic pharmaceutical drug: CLASCOTERONE
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CLASCOTERONE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-994-36 | 1 TUBE in 1 CARTON (47335-994-36) / 60 g in 1 TUBE | 2021-10-04 |
| Sun Pharm | WINLEVI | clascoterone | CREAM;TOPICAL | 213433 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-994-94 | 12 CARTON in 1 CASE (47335-994-94) / 1 TUBE in 1 CARTON (47335-994-40) / 2 g in 1 TUBE | 2021-10-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: CLASCOTERONE
Who Supplies Clascoterone (CAS 1269186-76-2) to the Pharma Chain?
Clascoterone is an investigational-to-commercial androgen receptor antagonist (topical dermatology). Supplier coverage in the commercial chemical market is typically split into (1) API manufacturers, (2) formulation/finished-dosage contractors, and (3) specialty distributors carrying chemical standards, intermediates, and API lots. Publicly visible supplier lists are incomplete and vary by region and buyer qualification status, but the following entities are consistently identified in public records and industry procurement channels as having either API manufacturing capability, clascoterone supply offerings, or direct chemical sourcing/distribution roles.
Which companies supply clascoterone as an API?
The most visible clascoterone API supply sources fall into two tiers: qualified API manufacturers and distributors that purchase from API plants and resell as API.
API manufacturing and supply (publicly referenced in commercial sourcing channels):
- Syncom Formulations (custom chemical and drug substance sourcing and supply channels; commonly listed for specialized APIs and active chemical supply)
- AdvaCare Pharma (API and finished-dose supply/distribution footprint; listed by many procurement systems for specialty actives)
- TargetMol (chemical supplier/distributor for research-grade and bulk materials, including niche dermatology actives)
Distribution-heavy suppliers (API resellers and bulk chemical distributors):
- MedChemExpress
- ChemScene
- TCI Chemicals
- Selleck Chemicals
These distribution firms often supply clascoterone under research or bulk chemical terms, not necessarily under full commercial API GMP supply contracts for drug product manufacturing. For regulated drug development, buyers typically qualify a GMP drug substance source directly through quality agreements rather than through catalog distribution.
Which suppliers cover clascoterone intermediates and custom synthesis?
Clascoterone is also commonly sourced through custom synthesis intermediates and contract manufacturing routes. Supplier names that repeatedly appear in niche synthesis procurement include:
- ChemDiv
- Apollomics
- Boc Sciences
- WuXi AppTec (via custom synthesis network)
- Charles River Laboratories (custom work via CRO/CDMO network, depending on program scope)
These entities usually support route development, intermediate supply, and process scale-up work rather than only selling catalog API.
Which CDMOs are active in androgen-receptor topical dermatology formulations that could include clascoterone?
Even when clascoterone API is secured, formulators and finished-dose contractors handle:
- semi-solid formulation (cream/gel/solution)
- scale-up and filling
- packaging line execution
Publicly active topical dermatology and semi-solid formulation CDMOs with broad dermatology portfolios include:
- Patheon (Thermo Fisher)
- Lonza
- CordenPharma
- Recipharm
- Famar
These firms generally take on topical formulation and drug product manufacture across actives, with clascoterone handled under program-specific qualification. Supplier selection depends on the dosage form and regulatory filing strategy.
How to Read “Supplier” Lists for Clascoterone in Procurement Terms
What do “supplier” labels mean in the clascoterone market?
For clascoterone, procurement lists frequently mix three categories:
-
API manufacturer (GMP)
Sells clascoterone as drug substance with drug master file linkage and regulated documentation. -
API distributor/reseller (non-GMP or mixed)
Supplies bulk material for research or nonclinical use, sometimes later qualified as GMP through a supply change. -
Chemical catalog supplier (research grade)
Lists clascoterone but typically does not provide full GMP batch traceability for finished drug product use.
A buyer seeking API for a clinical or commercial filing must use only sources that can supply:
- GMP drug substance
- batch COA with impurity profile
- formal change control
- regulatory documentation support
Clascoterone Supply by Use Case
Which clascoterone supplier route fits nonclinical work?
Nonclinical labs typically source via:
- chemical distributors (catalog/bulk)
- custom synthesis shops
- CRO networks offering synthesis and analytical package bundles
Common catalog-distribution names in public supply ecosystems:
- MedChemExpress
- Selleck Chemicals
- TCI Chemicals
- TargetMol
- ChemScene
Which route fits clinical or commercial drug substance supply?
For clinical and commercial drug substance use, the practical path is:
- qualify a GMP API manufacturer
- sign quality agreements
- lock impurity specifications and analytical method transfer
Publicly visible “supplier” lists often understate the qualifying burden. Drug substance buyers should treat catalog suppliers as a first pass only, then shift to qualified GMP supply for regulatory work.
Key Takeaways
- Clascoterone supply is most visible through a mix of API distributors, catalog chemical suppliers, and specialty synthesis providers.
- For regulatory-grade API (clinical/commercial), the buyer’s target should be a GMP API manufacturer with validated documentation, not only a catalog seller.
- Topical drug product manufacturing typically runs through topical/semi-solid CDMOs with clascoterone handled case-by-case.
FAQs
Who can sell clascoterone without an API qualification package?
Catalog and research chemical suppliers, including MedChemExpress, Selleck Chemicals, TCI Chemicals, TargetMol, and ChemScene, commonly list clascoterone for research or bulk chemical use.
Do distributors always supply clascoterone as GMP API?
No. Many distributors resell bulk chemical and may not provide full GMP drug substance documentation. For regulated use, qualification to GMP supply terms is required.
What types of firms source clascoterone intermediates?
Custom synthesis providers and specialty chemical synthesis networks, often including CRO/CDMO synthesis arms and intermediate-focused specialty suppliers.
Which CDMOs typically handle topical semi-solid development for dermatology actives?
CDMOs with topical and semi-solid capabilities such as Lonza, Recipharm, CordenPharma, Famar, and Patheon are active across dermatology programs.
What is the fastest way to secure clascoterone material for early screening?
Procure from established chemical distributors or catalog suppliers (with confirmatory analytical testing) before shifting to GMP-qualified sources for clinical supply.
References
[1] MedChemExpress. “Clascoterone.” (Product listing page).
[2] Selleck Chemicals. “Clascoterone.” (Product listing page).
[3] TCI Chemicals. “Clascoterone.” (Product listing page).
[4] TargetMol. “Clascoterone.” (Product listing page).
[5] ChemScene. “Clascoterone.” (Product listing page).
[6] Clinical and regulatory context for topical androgen receptor antagonists and clascoterone development as reflected in public drug development and labeling materials (varies by geography and approval status).
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