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Suppliers and packagers for generic pharmaceutical drug: azathioprine sodium
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azathioprine sodium
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hikma | AZATHIOPRINE SODIUM | azathioprine sodium | INJECTABLE;INJECTION | 074419 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9566-01 | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9566-01) / 10 mL in 1 VIAL | 1995-05-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Azathioprine Sodium: Supplier Landscape and Sourcing Priorities
What suppliers make azathioprine sodium?
Azathioprine sodium is typically supplied as a finished dosage ingredient form derived from azathioprine (or as a salt form standardized by customers’ specifications). In practice, commercial sourcing is done at two levels: (1) active pharmaceutical ingredient (API) manufacturers for azathioprine used to produce the sodium salt in-house or by a downstream salt-formulation partner, and (2) contract manufacturers that sell “azathioprine sodium” under their own finished spec and documentation package.
Because azathioprine is an off-patent, widely traded immunosuppressant, the supplier set is large and changes quickly by region, registration status, and the exact definition of “azathioprine sodium” used by each supplier (salt form, assay method, hydrate form, residual solvent and heavy metals limits, and re-test dating).
Which types of suppliers matter for procurement?
Procurement usually works across four supplier classes:
- API manufacturers (azathioprine; salt conversion by buyer or partner): Provides azathioprine bulk suitable for salt formation and GMP manufacturing.
- Salt-formulation or intermediate producers (azathioprine sodium as defined by their process): Sells azathioprine sodium under GMP with certificates, CoA, and stability packages.
- CDMO/CMO manufacturers (final drug product or investigational supply): Sources API or salt from their upstream chain and manufactures your bulk drug substance, investigational material, or finished dosage.
- Distributors and trading houses: Re-sell registered or qualified materials; useful when you need fast access to documentation and regional availability.
What procurement specs differentiate “azathioprine sodium” quotes?
Quotes vary because “azathioprine sodium” can be defined and controlled through different parameter sets. In supplier due diligence, treat the following as negotiation drivers:
- API identity and salt definition
- Salt form definition (what the supplier calls “sodium”)
- Polymorph/hydrate controls if applicable
- Acceptance criteria for identity (typically HPLC and/or IR/SS tests)
- Assay and impurities
- Assay method and acceptance range
- Related substances panel (specified impurities list vs total impurities)
- Impurity thresholds tied to specific degradation pathways
- Residual solvents and contaminants
- Class 1 to 3 residual solvent limits
- Heavy metals, elemental impurities, and micro controls if relevant to your intended manufacturing step
- Stability and re-test window
- Real-time and accelerated stability data
- Storage conditions and retest dating
- Packaging configuration and moisture protection requirements
- Regulatory documentation
- GMP certificate (site-level)
- DMF/CEP availability (where applicable)
- Traceability and change control commitments
Supplier list: mainstream sourcing channels (practice-based)
Below is a supplier map built from how azathioprine materials are sourced in commercial supply chains. This list is structured by supplier type rather than assuming every entity sells “azathioprine sodium” under that exact name in every jurisdiction.
API and chemical manufacturer channels
Common upstream sources for azathioprine supply into GMP chains include large generics and specialty API manufacturers. Many of these firms supply azathioprine bulk that is then converted to a salt form by the customer or a downstream salt-formulation step.
Typical upstream supplier categories to target
- Large Indian and Chinese API manufacturers with azathioprine production history
- Specialty chemical intermediates suppliers with GMP capability
- Western API producers with DMF/CEP and established audit programs
Salt-formulation / intermediate vendors
Salt form vendors sell defined salt material with specific impurity profiles and controlled residuals. In due diligence, the key is whether the supplier:
- documents the exact salt-form identity you need,
- provides full analytical method coverage,
- and supports your stability program.
Distributors
Distributors are useful for:
- fast CoA access,
- reduced onboarding time,
- and regional logistics.
But distributors rarely control upstream impurity profiles; they pass through CoAs and upstream documentation. For regulated manufacturing, you usually qualify the original manufacturing site anyway.
What to prioritize when selecting a supplier
For azathioprine sodium, selection is usually less about “who can supply” and more about “who can document and control.” The short list of qualification priorities:
- Site GMP status (current inspection standing and data integrity posture)
- Salt-definition clarity (what exact material is delivered as “azathioprine sodium”)
- Impurity profile control (related substances, degradation peaks, and consistent CoAs lot-to-lot)
- Analytical method transparency (HPLC method package or cross-reference to pharmacopeial methods)
- Stability support (your shelf-life and retest plan fit)
- Supply continuity (capacity availability and lead-time history)
Sourcing risk flags specific to salt-form materials
Salt forms introduce extra variability versus “neutral” API bulk. Flag the following during qualification:
- Salt-hydrate variability: moisture uptake can change assay and impurity profile.
- Inconsistent conversion: supplier conversion endpoint and washing/drying parameters affect residuals.
- Over-reliance on distributor CoAs: distributors can shift upstream lots without your approval.
- Slow change-control execution: salt process changes can alter impurity thresholds and require analytical revalidation.
Recommended qualification route (supplier onboarding)
A practical, audit-ready qualification plan:
- Stage 1: documentation package
- GMP certificate, CoA format, specification sheet, analytical report examples
- DMF/CEP if applicable for your region
- Stage 2: lab comparability
- Identity confirmation and impurity/assay comparability against your internal spec
- Moisture and form check if your process depends on salt behavior
- Stage 3: process impact review
- Fit with your salt conversion step (if you do it) or with your downstream formulation
- Stage 4: stability and retain sampling
- Retain reserve samples from initial lots
- Align stability protocol to your storage and labeling claims
Key Takeaways
- Azathioprine sodium sourcing is dominated by a large, global supplier base, with many suppliers supplying azathioprine bulk and leaving salt conversion to the customer or a downstream partner.
- Supplier differentiation comes from salt-definition clarity, impurity control, stability support, and documentation strength, not from the availability of bulk material.
- Qualification should treat “azathioprine sodium” as a controlled identity with form and moisture behavior, supported by consistent CoAs and analytical comparability.
FAQs
What is the most common upstream material used for azathioprine sodium?
Most supply chains start from azathioprine bulk, then use customer-side or downstream salt formation to produce “azathioprine sodium” in a controlled specification.
Do distributors guarantee the same salt form across lots?
Distributors pass through upstream lots. They can provide CoAs, but lot-to-lot salt-form and impurity consistency usually needs qualification tied to the original manufacturing site and stable process documentation.
Which specs most often cause supplier quote divergence?
Salt identity definition, assay method and acceptance ranges, the related substances panel, residual solvents, and stability/retest periods.
How should buyers validate salt form for GMP manufacturing?
Validate with identity and impurity comparability, and include form/moisture checks if your process or formulation is sensitive to hydrate or moisture uptake.
What documents matter most for regulated submissions?
GMP certificates for the manufacturing site, CoAs and full specifications, and any DMF/CEP documentation that aligns with your target market filing requirements.
References
[1] European Medicines Agency. “Azathioprine.” EMA (substance and related documentation). https://www.ema.europa.eu/
[2] U.S. Food and Drug Administration. “Drugs@FDA.” FDA (product and labeling references for azathioprine-related information). https://www.accessdata.fda.gov/scripts/cder/daf/
[3] USP. “Azathioprine.” United States Pharmacopeia (USP) (monographs and specifications used by industry). https://www.uspnf.com/
[4] ChemBK / Chemical supplier databases (market listings for azathioprine and salt forms). https://www.chemblink.com/
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