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Suppliers and packagers for xanax
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xanax
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Upjohn | XANAX | alprazolam | TABLET;ORAL | 018276 | NDA | PHARMACIA & UPJOHN COMPANY LLC | 0009-0029-01 | 100 TABLET in 1 BOTTLE (0009-0029-01) | 1981-10-16 |
| Upjohn | XANAX | alprazolam | TABLET;ORAL | 018276 | NDA | PHARMACIA & UPJOHN COMPANY LLC | 0009-0029-02 | 500 TABLET in 1 BOTTLE (0009-0029-02) | 1981-10-16 |
| Upjohn | XANAX | alprazolam | TABLET;ORAL | 018276 | NDA | PHARMACIA & UPJOHN COMPANY LLC | 0009-0055-01 | 100 TABLET in 1 BOTTLE (0009-0055-01) | 1981-10-16 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Xanax (Alprazolam) Suppliers: What the Supply Chain Actually Covers
Xanax is brand-name alprazolam, a benzodiazepine. Commercial supply is split across (1) active pharmaceutical ingredient (API) manufacturers (alprazolam), (2) finished-dose manufacturers (Xanax tablets), and (3) global distributors that move finished product and APIs through regulated channels.
Because “suppliers for Xanax” can mean different points in the chain, this answer is structured as API suppliers and finished-dose suppliers (who manufactures the marketed tablets), with the practical procurement view for each.
Who supplies Xanax tablets (finished-dose manufacturer)?
Xanax tablets are marketed in multiple countries and typically manufactured under contracts that vary by market and packaging site. In the US, Xanax is marketed by Pfizer and manufactured through Pfizer’s supply network and contracted manufacturing sites depending on strength and label configuration.
| Market/Label | Brand | Active | Marketer (typical) | Finished-dose manufacturer (typical model) |
|---|---|---|---|---|
| United States | Xanax | Alprazolam | Pfizer | Pfizer network and approved contract manufacturers (market-specific) |
Procurement implication: if you are buying “Xanax,” you are buying the NDA/label version (strength, dosage form, packaging) that the marketer controls; you cannot substitute an unapproved manufacturer without regulatory and supply approval.
Who supplies the alprazolam API (API manufacturers)?
Alprazolam API is produced by a set of specialized small-molecule API manufacturers. Commonly, companies in India and China supply alprazolam API into global markets via DMF-held or CEP/inspection-ready supply. API suppliers can change by batch/market due to qualification, inspection outcomes, and supply continuity requirements.
| Supplier type | What they provide | Typical documentation footprint | What changes in procurement |
|---|---|---|---|
| API manufacturer | Alprazolam (USP/EP grades) | DMF filings, CoA/CoC, inspection history, impurity profile | Qualification and recurring batch testing |
| API broker/distributor | API sourcing plus compliance | Traceability and documentation pass-through | Supplier substitution risk without requalification |
Procurement implication: For controlled substances, API procurement is constrained by registration and diversion controls even when the chemical is commercially available.
What approvals and compliance determine who can supply Xanax/Alprazolam?
Drug substance (alprazolam API) controls
Xanax tablets’ quality depends on the API meeting approved specifications and impurity limits. For benzodiazepines, impurity and residual solvent controls are enforced by the approved drug application and GMP inspection outcomes.
Drug product (Xanax tablets) controls
Finished-dose manufacturing requires:
- GMP compliance for the solid oral dose
- master/packaging controls
- controlled-substance handling and distribution controls
Controlled-substance and distribution controls
Alprazolam is a Schedule IV controlled substance in the US. Handling, distribution, and recordkeeping require DEA registration and compliant logistics.
How to interpret “suppliers” for Xanax in a procurement workflow
If you want to source finished Xanax tablets
You must treat “supplier” as a qualified finished-dose source that can provide:
- labeled finished product matching the market’s dosage form and strength
- regulatory documents and CoA
- controlled substance shipping and receiving compliance
If you want to source alprazolam API
You must treat “supplier” as an API source qualified for:
- approved impurity limits and analytical methods
- DMF/CEP alignment (if applicable to your regulatory pathway)
- GMP history and audit readiness
Key supply-chain constraints for alprazolam/Xanax
- Limited qualified producers: benzodiazepine API production is specialized and inspection-driven.
- Regulatory gating: to supply either API or finished product, vendors must meet traceability and controlled-substance compliance.
- Batch-to-batch qualification: even when an API supplier is “approved,” each incoming lot may trigger testing and release steps.
- Market-by-market manufacturing: tablet manufacturing sites can vary by market, packaging configurations, and label strength.
Key Takeaways
- “Suppliers for Xanax” breaks into finished-dose manufacturers for tablets and alprazolam API manufacturers.
- In the US, Pfizer is the marketer for Xanax, and finished-dose manufacturing is executed through Pfizer’s qualified supply network and contracted approved manufacturers.
- Alprazolam API is supplied by specialized API manufacturers (often India/China-based in global trade), but qualification depends on DMF/CEP alignment, impurity profiles, and GMP/inspection outcomes.
- Alprazolam’s Schedule IV status makes controlled-substance compliance (DEA registration, diversion controls, and compliant logistics) a hard gating factor for any supplier.
FAQs
1) Can I buy alprazolam API from any chemical supplier?
No. Supply requires regulatory and quality alignment for benzodiazepine API use, including controlled-substance handling requirements and GMP-quality documentation.
2) Who is the supplier of record for Xanax in the US?
Xanax is marketed by Pfizer in the US; the tablet supply comes from Pfizer’s qualified manufacturing network for the specific product configuration.
3) What is alprazolam’s controlled substance status in the US?
Alprazolam is Schedule IV under the US Controlled Substances Act.
4) Do API suppliers match tablet suppliers 1:1?
No. API supply and finished-dose manufacturing can be different entities; multiple API suppliers can feed multiple tablet manufacturers.
5) Why do “Xanax suppliers” vary by strength and packaging?
Because finished-dose manufacturing, packaging, and label configurations can be executed at different qualified sites and for different product presentations.
References
[1] FDA. Drug Product Labeling (Xanax, alprazolam). U.S. Food and Drug Administration.
[2] U.S. Drug Enforcement Administration (DEA). Controlled Substances: Schedules of Controlled Substances (Schedule IV listing for alprazolam).
[3] FDA. Current Good Manufacturing Practice (CGMP) regulations and drug quality standards for finished pharmaceuticals and drug substances. U.S. Food and Drug Administration.
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