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Suppliers and packagers for VINBLASTINE SULFATE
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VINBLASTINE SULFATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | VINBLASTINE SULFATE | vinblastine sulfate | INJECTABLE;INJECTION | 089515 | ANDA | Fresenius Kabi USA, LLC | 63323-278-10 | 1 VIAL, MULTI-DOSE in 1 BOX (63323-278-10) / 10 mL in 1 VIAL, MULTI-DOSE | 2000-07-12 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for VINBLASTINE SULFATE
VINBLASTINE SULFATE: Who Supplies the API and What to Verify in Procurement
Vinblastine sulfate is a naturally derived vinca alkaloid used in oncology. Because global manufacturing capacity and sourcing can shift with crop yields, extraction volumes, and regulatory scrutiny, procurement decisions should be anchored to: (i) API regulatory status, (ii) manufacturing chain-of-custody for source material (Catharanthus roseus), and (iii) documented quality systems for complex natural products.
Who supplies vinblastine sulfate (API) in commercial channels?
Vinblastine sulfate is commonly supplied by (1) branded originator-linked distributors for finished dosage forms and (2) specialized chemical and API traders for the bulk pharmaceutical substance. For API procurement, the practical universe is dominated by manufacturers and distributors that can provide drug master file (DMF) linkage or equivalent quality documentation.
Below is the supplier map that buyers typically face when sourcing vinblastine sulfate API and related bulk material. Use it as a targeted starting list for supplier qualification and regulatory due diligence.
API and bulk substance supplier archetypes
| Supplier type | What they typically provide | Why it matters for vinblastine sulfate |
|---|---|---|
| API manufacturer or contract manufacturer (CMO) | CoA, spec sheet, DMF/CEP/other regulatory package, GMP batch records | Ensures reproducible alkaloid profile and validated extraction + purification |
| Specialized chemical distributor (API trader) | Catalog material, CoA, letters of suitability, sometimes DMF linkage | Often faster sourcing but quality package varies by lot and lane |
| Finished dosage form suppliers | Injection product (multi-dose vials) instead of API | Useful for continuity of supply but does not replace API sourcing |
What procurement documents and checks should be tied to supplier qualification?
Vinblastine sulfate is a controlled, potency-sensitive natural product. Buyers should not qualify based on price or lead time alone.
API qualification artifacts to request during supplier onboarding
- GMP status evidence: site authorization, inspection outcomes or certifications, and whether the material is manufactured under cGMP (or equivalent).
- Specification package: identity, assay, impurity profile, moisture/solvent limits, and alkaloid-related impurities.
- Analytical methods: validated test procedures (HPLC/LC method description for vinblastine assay and impurities).
- Batch documentation: CoA for at least the last 3 commercial lots and traceable manufacturing record summary.
- Chain-of-custody: confirmation of source plant material controls (where applicable) and validated upstream variability controls.
- Regulatory file mapping: DMF reference (or equivalent) that matches your target market and product submission strategy.
What to verify about product form: sulfate salt, strength, and container
Procurement should confirm the exact salt form and presentation, because natural product procurement can differ by:
- Salt form: vinblastine sulfate vs free base.
- Typical API presentation: sterile manufacturing lanes may demand specific grades or packaging requirements.
- Potency and assay: vinblastine sulfate potency is typically expressed relative to assay against labeled standard.
Buyer checklist (non-negotiable)
| Item | Verification target |
|---|---|
| Chemical identity | Matching analytical identity tests and method equivalency |
| Assay and potency | Batch-level assay at spec limits with clear reference standard control |
| Impurity profile | Specific named impurities and total impurity limits aligned to your spec |
| GMP and controls | Evidence that the site and process are qualified for complex natural extracts |
| Lot traceability | Full batch genealogy from starting material to final API |
How suppliers typically differentiate vinblastine sulfate quality
In buyer practice, differentiation is usually driven by:
- Extraction and purification consistency (alkaloid variability control)
- Impurity management (control of related vinca alkaloids and process-related impurities)
- Analytics robustness (validated LC methods and reference standard stability)
- Regulatory readiness (DMF completeness, responsiveness, and controlled tech transfer readiness)
Key supply-chain risks that filter supplier fit
Vinblastine sulfate is exposed to operational risks that influence supplier selection:
- Upstream plant variability affecting yield and impurity distribution
- Bottlenecks in extraction capacity that impact continuity of supply
- Regulatory scrutiny for natural-product impurity profiles and method validation
- Special handling and export lane constraints for controlled oncology APIs
Market-ready supplier selection criteria (actionable)
If you are selecting a supplier for vinblastine sulfate API, prioritize suppliers who can provide:
- Regulatory package compatibility
- DMF/CEP or documented equivalent for your intended markets
- Quality system evidence
- GMP manufacturing under recognized frameworks and traceable CoA history
- Consistency
- Stable impurity profile across multiple lots (trend data, not single CoAs)
- Method transparency
- Access to validated assay and impurity methods and reference standards
- Supply continuity
- Capacity and planned production schedules that match your required timeline
Key Takeaways
- Vinblastine sulfate sourcing is dominated by specialized API manufacturers/CMOs and qualified API distributors; supplier selection must be anchored to GMP status, DMF or equivalent regulatory readiness, and validated analytics for assay and impurities.
- The buyer qualification must include chain-of-custody controls for the source plant material and trend-based impurity/assay evidence across multiple lots.
- Procurement readiness improves when supplier documentation covers identity, assay, impurity methods, reference standard control, and complete lot traceability.
FAQs
1) Is vinblastine sulfate typically sourced as an API or as part of finished injections?
Both exist. For manufacturing inputs, buyers typically source vinblastine sulfate API; for immediate continuity, they may source finished injection if API lanes are constrained.
2) What is the most important quality attribute to check beyond assay?
The impurity profile tied to a validated LC method, including named related alkaloids and total impurities, is usually the most critical attribute for acceptance.
3) Do suppliers vary by geographic region for vinblastine sulfate?
Yes. Regulatory status, inspection outcomes, and documentation completeness vary by site and country, which affects submission readiness even when specs look similar.
4) Why does natural-product sourcing change lot-to-lot behavior?
Plant-derived extraction can vary with agricultural yield and starting material variability, which can shift impurities and requires validated process controls.
5) What should be demanded for regulatory submission readiness?
A coherent regulatory package (DMF or equivalent), aligned specs, and validated test methods that match your target market’s expectations.
References
[1] FDA. Drug Master Files (DMFs). U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-master-files-dmfs
[2] EMA. European Medicines Agency: Regulatory information and quality requirements (general guidance for API quality). https://www.ema.europa.eu/en/medicines
[3] ICH. ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. International Council for Harmonisation. https://www.ich.org/page/quality-guidelines
[4] ICH. ICH Q3A/Q3B: Impurities in New Drug Substances/Products. International Council for Harmonisation. https://www.ich.org/page/quality-guidelines
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