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Suppliers and packagers for generic pharmaceutical drug: DUTASTERIDE
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DUTASTERIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Waylis Therap | AVODART | dutasteride | CAPSULE;ORAL | 021319 | NDA | Waylis Therapeutics LLC | 80725-712-04 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (80725-712-04) | 2022-12-15 |
| Waylis Therap | AVODART | dutasteride | CAPSULE;ORAL | 021319 | NDA | Waylis Therapeutics LLC | 80725-712-15 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (80725-712-15) | 2022-12-15 |
| Adaptis | DUTASTERIDE | dutasteride | CAPSULE;ORAL | 204376 | ANDA | MARKSANS PHARMA LIMITED | 25000-011-03 | 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-011-03) | 2017-04-27 |
| Adaptis | DUTASTERIDE | dutasteride | CAPSULE;ORAL | 204376 | ANDA | MARKSANS PHARMA LIMITED | 25000-011-07 | 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-011-07) | 2017-04-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: DUTASTERIDE
Dutasteride Drug Suppliers: Active Pharmaceutical Ingredient (API) Manufacturers, Fill-Finish Partners, and Contract Supply Landscape
Dutasteride’s supply chain centers on a small number of API manufacturers, with downstream fill-finish (tablet manufacturing and packaging) typically handled by regional generic and branded-capable CMOs. Supplier mapping depends on strength (0.5 mg tablets are standard), dosage form (oral capsule/tablet only, depending on product), and whether the buyer needs branded supply, US generic supply, or export-ready product.
Who supplies the dutasteride API (active pharmaceutical ingredient) globally?
API manufacturing hubs and typical supplier tiers
- API synthesis and purification: core dutasteride manufacturers producing API suitable for regulated markets (FDA DMF-supported, CEP/EDMF-supported, or both).
- Polymorph and impurity-controlled API supply: suppliers that provide CoA, impurity profiles, and compliance packages for ANDA filing readiness.
- Custom intermediates sourcing: some suppliers provide dutasteride starting materials or key intermediates rather than full API.
What buyers usually require from dutasteride API suppliers
- DMF/EDMF status aligned to the buyer’s target market (US ANDA, EU generics).
- Impurity controls aligned to pharmacopeial and regulatory expectations (process-related impurities and elemental limits).
- GMP certification coverage for the specific dosage strength and intended customer.
- Supply continuity and lead times suitable for regulatory launch windows.
Patent and regulatory note driving supplier choice: dutasteride is an established molecule with multiple generic entries; supplier selection usually prioritizes compliance readiness for FDA quality review rather than novelty.
Which companies supply dutasteride 0.5 mg tablets for generics and brands?
Common fill-finish and tablet manufacturing model
Most “finished dosage form” supply for dutasteride is produced by:
- Generic-specialist manufacturers (own plants or contract manufacturing)
- Branded pharmaceutical manufacturing networks with outsource capacity
- Fill-finish CMOs that buy the API and produce compliant tablets with packaging
What changes by market
- US: finished goods and packaging must align with ANDA product requirements and facility inspections.
- EU/UK: GMP and QP release structures dictate supplier qualification.
- Emerging markets: quality packages often depend on buyer auditing intensity and documentation depth.
What is the regulatory qualification status that matters for dutasteride suppliers (FDA DMF/ANDA-linked)?
US ANDA linkage
In practice, dutasteride generic launches often rely on:
- API manufacturers listed in the buyer’s ANDA technical sections (via DMF references).
- Finished dosage manufacturers that can be inspected for CGMP compliance.
- Quality systems supporting routine and change-controlled scale-up.
What to screen in supplier qualification
- Whether the supplier’s API is supported by an FDA DMF (for US filings).
- Whether the supplier can provide a full compliance dossier: CoA, impurity specs, residual solvent/elemental tests, stability package, and shipping temperature guidance.
- Whether the finished dosage facility supports the buyer’s intended labeling and packaging format (bottle count, blister format, child-resistant packaging).
Which suppliers specialize in dutasteride API with high compliance for ANDA filings?
Selection criteria that drive procurement
Procurement teams typically select among API suppliers that can demonstrate:
- Consistent impurity profile across batches.
- Documented change control history (process, solvent, crystallization, drying parameters).
- Stability support for dutasteride API and/or finished product.
- Scale-up readiness for launch quantities.
Commercial risk controls
High-reliability dutasteride suppliers typically provide:
- Forecasting commitments tied to buyer launch calendars.
- Batch-to-batch traceability.
- Rapid response on deviations and regulatory questions.
How to compare dutasteride suppliers by cost, capacity, and lead time?
Cost drivers
- API grade and compliance burden (DMF-ready vs non-US-comparable supply).
- Crystallization and drying economics (yield and polymorph control).
- Finished goods approach (direct tableting vs subcontracted fill-finish).
Capacity and lead time
- API lead times depend on synthesis cycle time, crystallization schedule, and drying/stability hold windows.
- Finished goods lead times depend on batch slot availability and packaging procurement (bottles, blisters, carton formats).
A practical supplier scoring model
Use procurement-weighted scoring:
- Regulatory readiness (DMF/EDMF/QP readiness)
- Consistency (impurity controls and CoA variability)
- Schedule reliability (on-time delivery rate and change control discipline)
- Contract terms (supply assurance, forecast/penalty alignment)
- Quality agreements (deviation handling, audit cadence, CAPA timelines)
What packaging and dosage-form constraints affect dutasteride suppliers?
Standard marketed format
Dutasteride is typically supplied as oral solid dosage (most commonly 0.5 mg tablets in multi-count bottles or blister packs, depending on market).
What procurement must lock
- Tablet specification: hardness, friability, disintegration, dissolution profile alignment.
- Packaging format requirements (bottle vs blister; count; labeling language and NDC/GTIN mapping).
- Stability and shelf-life claims for the finished product configuration.
What contract manufacturing and fill-finish options exist for dutasteride tablets?
Fill-finish decision points
- Whether the CMO provides complete manufacturing starting from API or only tableting and packaging.
- Whether the CMO can support ANDA-required scale-up and validation packages.
- Whether the CMO supports customization: imprinting, packaging format changes, and labeling versions.
Typical engagement structure
- Quality agreement, master batch record alignment, and change control governance.
- Validation plans for mixing/granulation, compression, coating (if used), and packaging lines.
What supplier risks exist for dutasteride (single-source, raw material, compliance)?
Supply disruption risk
- API suppliers may face downtime due to purification issues, solvent shortages, or inspection outcomes.
- Intermediate supply constraints can delay API batches.
Quality and regulatory risk
- Deviations in crystallization or drying can shift impurity profiles.
- Facility inspection outcomes can restrict market release quickly.
Mitigation
- Dual-source qualification for API and, where feasible, finished goods.
- Contract clauses tied to batch release timing, not just shipment dates.
- Pre-approved alternate packaging components and labeling formats.
Do any dutasteride biosimilar or biologic supply issues apply?
No. Dutasteride is a small-molecule androgen-reductase inhibitor. Supply chain issues are standard for chemical APIs and solid oral dosage forms. The “biosimilar” concept does not apply.
Key Takeaways
- Dutasteride supply is primarily an API-plus-finished-dosage sourcing exercise, with regulatory qualification centered on DMF-ready API and GMP-aligned tablet/fill-finish capability.
- Supplier selection should be driven by ANDA/quality readiness: DMF linkage (US), impurity control consistency, and the ability to support stability and batch release schedules.
- The biggest procurement risks are single-source API dependence, crystallization-related impurity drift, and packaging lead-time disruptions during launch windows.
- A high-confidence procurement strategy uses dual-source qualification and contract terms tied to batch release timing and change control governance.
FAQs
Which firms manufacture dutasteride API for US-regulated markets?
API suppliers that support FDA DMF referencing for US filings are the typical candidates; finished-dosage and ANDA buyers usually qualify based on DMF availability, impurity control documentation, and inspection history.
Can I source dutasteride tablets without owning a manufacturing facility?
Yes. Buyers typically contract a tablet manufacturer or fill-finish CMO that can tableting and packaging under GMP, using either buyer-supplied API or the CMO’s API supply.
What is the standard dutasteride dosage form used by generic manufacturers?
Most generic supply targets 0.5 mg oral solid dosage forms (tablets), with variations in packaging format by market.
What supplier documents are most important for regulatory audits?
CoA with full impurity panels, DMF/EDMF documentation (for API), stability data, batch records summaries, and quality agreement terms for deviations and CAPA timelines.
What typically causes delays in dutasteride supply?
API batch cycle disruptions tied to crystallization or purification, packaging component lead times, and quality investigations following deviations that delay batch release.
References (APA)
- FDA. (n.d.). Drug Master Files (DMF). U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-master-files-dmfs
- EMA. (n.d.). European Medicines Agency: Human medicines. European Medicines Agency. https://www.ema.europa.eu/en/human-medicines
- USP. (n.d.). USP General Chapters and monographs. United States Pharmacopeia. https://www.uspnf.com/
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