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Suppliers and packagers for col-probenecid
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col-probenecid
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | COL-PROBENECID | colchicine; probenecid | TABLET;ORAL | 084279 | ANDA | Actavis Pharma, Inc. | 0591-5325-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0591-5325-01) | 1982-10-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for col-probenecid
Col-Probenecid: Supplier Map for the Active Ingredient and Key Build Materials
What are the main supply routes for col-probenecid?
“Col-probenecid” is a combination product in the colchicine + probenecid space. In the supply chain, companies typically source either:
1) Colchicine and probenecid as separate APIs, then formulate into the fixed-dose drug product, or
2) A packaged/contract-manufactured combination from a CDMO that supplies the final dosage form (tablet/capsule) under contract.
Because “supplier” can mean API manufacturers or finished-dose packagers, the most actionable approach is to map API supply (colchicine API, probenecid API) and drug product CDMOs that handle combination tablets/capsules.
Who supplies probenecid API?
Which companies are active in probenecid API supply?
Probenecid is a legacy uricosuric API with recurring commercial supply. The supplier set below represents common market channels for probenecid API sourcing into drug product manufacturing.
| Supplier category | Common supplier profiles | What they typically provide |
|---|---|---|
| API manufacturers | Chemical/API producers serving global pharma markets | Probenecid API (various grades; often DMF-supported) |
| Specialty chemical manufacturers | Legacy small-molecule producers | Probenecid as bulk starting material for API teams |
| Regional API distributors | Trading houses and pharma ingredient distributors | Sourced API lots from approved manufacturers |
Actionable sourcing note (procurement reality): For fixed-dose products that include probenecid, buyers usually qualify at least one DMF-backed API manufacturer plus an approved backup source, then lock specs through quality agreement.
Who supplies colchicine API for the combination?
Which companies are active in colchicine API supply?
Colchicine has a different supply base than probenecid. It is also long-commercialized and typically sourced from specialized API manufacturers with consistent impurity control.
| Supplier category | Common supplier profiles | What they typically provide |
|---|---|---|
| Colchicine API manufacturers | Pharma-grade API producers | Colchicine API with controlled impurities |
| Extract-to-API vertically integrated firms | Firms that control raw material to API | Colchicine API with tighter traceability |
| Distributors | Ingredient supply intermediaries | Bulk API lots with documentation |
Actionable sourcing note: Buyers usually prioritize impurity profile stability and documentation (CoA, impurity acceptance criteria, stability data when available).
Who supplies the combination drug product (colchicine + probenecid) as a finished dose?
Which CDMOs support combination tablets/capsules containing probenecid?
Finished-dose manufacturing is handled by CDMOs with tablet/capsule lines, formulation development, and packaging. For combination products, CDMOs typically need:
- Controlled blending for dose uniformity
- Stability management for colchicine (light/heat sensitivity controls depend on formulation)
- Strong change-control processes for any formulation or supplier substitutions
| CDMO capability | What it matters for col-probenecid | Typical deliverables |
|---|---|---|
| Solid oral formulation | Tablet/capsule manufacturing with dose uniformity | Batches, scale-up, process parameters |
| GMP packaging | Blistering/bottling and labeling | Primary and secondary packaging validation |
| Analytical and stability support | Shelf-life establishment | Method transfer, stability protocol, release testing |
Actionable sourcing note: For combination fixed-dose products, the procurement focus is often on tablet/capsule line capacity plus ability to qualify both APIs under a single quality system.
What supplier qualification requirements usually gate col-probenecid procurement?
What documentation and quality controls are required?
Across API and drug product sourcing, buyers usually require:
- GMP status: manufacturing under GMP for the intended market (commonly EU GMP, US FDA GMP alignment, or comparable)
- API documentation: CoA, impurity profile/limits, polymorph or crystal form controls when relevant, and stability data or referenced specs
- Regulatory support: DMF/CEP/ASMF linkage when available
- Quality agreement: audit rights, change notifications, complaint handling, deviation control, and requalification triggers
- Analytical methods: validated release methods or method transfer packages for drug product release testing
Procurement shortlist structure (how buyers build the supplier set)
How do high-stakes buyers structure a col-probenecid supply plan?
A robust plan typically uses a 2-tier strategy: 1) Primary API manufacturers for colchicine and probenecid with consistent documentation and impurity control. 2) Secondary/backup sources for each API to reduce lead-time risk. 3) One or two CDMOs for finished-dose manufacturing to keep tech transfer and release testing aligned.
This structure reduces dependency on a single raw material supply chain and shortens recovery after a supply disruption.
Key Takeaways
- Col-probenecid supply is executed through APIs plus finished-dose manufacturing: most suppliers sit either at the API level (colchicine API, probenecid API) or at the CDMO level for combination tablet/capsule production.
- Procurement should be qualification-led: buyers prioritize DMF/CEP or equivalent regulatory support, impurity profile stability, GMP documentation, and a quality agreement with change control.
- Use a two-tier model: qualify at least one backup source per API and keep one primary CDMO plus a secondary option for manufacturing continuity.
- Solid oral CDMO capability is the gating factor for the combination: dose uniformity, blending control, packaging validation, and stability program execution drive feasibility for col-probenecid fixed-dose products.
FAQs
1) Is “col-probenecid” typically supplied as a single API?
No. The market supply chain usually sources colchicine and probenecid as separate inputs and then formulates into a fixed-dose solid oral product.
2) What matters most for probenecid API sourcing?
Consistency in impurity profile, spec compliance, and GMP/regulatory documentation that supports cross-market release.
3) What matters most for colchicine API sourcing?
Traceable raw material handling and controlled impurity profile stability, with validated release testing documentation.
4) What capability must a CDMO have for col-probenecid tablets/capsules?
Solid oral manufacturing with proven dose uniformity controls, validated release testing alignment, packaging validation, and an executed stability program.
5) How do buyers manage supply risk for legacy combinations?
By qualifying primary and backup API suppliers and keeping CDMO manufacturing continuity through tech transfer and shared quality agreements.
References
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