Last updated: April 23, 2026
What is “allopurinol sodium” in commercial terms?
“Allopurinol sodium” is an alternate salt form of allopurinol, the xanthine oxidase inhibitor used to manage hyperuricemia and gout. In supply chains and procurement documents, products may appear under:
- Allopurinol (drug substance) (often the primary SKU)
- Allopurinol sodium (API/salt form) (salt-form naming used by some manufacturers)
- Allopurinol sodium for injection or sterile preparations (only for specific dosage forms and labeling)
Because naming varies by dossier strategy and labeling practice, suppliers are typically identified by CAS alignment to allopurinol and by regulatory product labeling that explicitly uses the “sodium” descriptor where applicable.
Which suppliers manufacture allopurinol sodium or market it as an allopurinol salt?
Below are supplier profiles that appear in real-world sourcing and regulatory ecosystems for allopurinol (and/or allopurinol sodium as the salt form). Procurement diligence should confirm the salt form on the Certificate of Analysis (CoA) and the intended market registration.
API and salt-form manufacturers
| Supplier |
Output |
Typical role |
Market presence signals (examples) |
| Sandoz |
Allopurinol products (marketed globally) |
Brand/manufacturer |
Product registrations and generics distribution networks in EU and multiple jurisdictions |
| Teva |
Allopurinol formulations |
Brand/manufacturer |
Established generics footprint with allopurinol line items |
| Dr. Reddy’s Laboratories |
Allopurinol formulations / API supply chain |
Generic manufacturer |
Broad portfolio and dossier manufacturing footprint |
| Accord Healthcare |
Allopurinol formulations |
Generic manufacturer |
EU/UK supply presence for urate-lowering products |
| Mylan (Upjohn brand history) |
Allopurinol formulations |
Generic manufacturer |
Multi-jurisdiction generics distribution |
| Siegfried |
APIs/intermediates (varies by site) |
Contract manufacturer |
API manufacturing capability across multiple chemistries; allopurinol may appear by site/SKU |
| Lupin |
Allopurinol formulations |
Generic manufacturer |
Global generics supply |
| Hikma |
Allopurinol formulations |
Generic manufacturer |
EU and US generics supply base |
Specialty and regional generic manufacturers that can supply salt-form variants
The practical bottleneck for “allopurinol sodium” as a named salt often sits in dossier naming rather than in a separate chemistry line. Regional suppliers that commonly file and manufacture allopurinol dossiers are the most likely to support a salt-named variant under controlled documentation.
Common categories to target in RFPs:
- EU generics manufacturers (large dossier libraries, consistent GMP documentation)
- US ANDA holders with robust API control systems
- Contract manufacturing organizations (CMOs) for API and salt formation where the dossier naming can be tailored
How do you identify “allopurinol sodium” suppliers in procurement?
In pharma procurement, the fastest path to correct supplier selection is to verify the following fields in the vendor’s technical pack:
- Chemical identity: allopurinol salt form confirmation (not just allopurinol free base)
- Specification set: assay, impurities, and water form consistent with the labeled salt
- Regulatory alignment: alignment to the intended dossier (EU SmPC label, US ANDA labeling, or national registration)
- Manufacturing control: salt formation or crystallization step documentation where “sodium” is asserted
Which supplier types have the highest chance to supply a salt-named variant?
| Supplier type |
Why it matters for “allopurinol sodium” |
| Brand and large generics |
They often control formulation and dossier naming and can align salt claims to registration |
| API houses with controlled crystallization |
They can deliver salt-defined material with consistent specifications |
| CMOs for solids and salt screening |
They support transformation from allopurinol to specific salt forms under GMP controls |
What documentation to demand to avoid mix-ups between “allopurinol” and “allopurinol sodium”?
A supplier should be able to provide, at minimum:
- CoA showing the salt form consistent with “sodium”
- Analytical package: HPLC assay/impurity profile plus solid-state characterization when the salt form is claimed
- Master/production batch record summary describing the salt formation step (if applicable)
- Letter stating the marketed material corresponds to the named salt used in the regulatory filing
Key market reality: many suppliers list “allopurinol,” not “allopurinol sodium”
Most commercial catalogs and registrations use allopurinol rather than a specific salt descriptor. “Allopurinol sodium” naming may appear:
- In technical documentation for a specific intermediate salt stage
- In certain formulation dossiers or legacy labeling conventions
- In niche product lines or cross-market labeling differences
This is why supplier shortlists should be built from allopurinol-capable manufacturers and then filtered by salt-form confirmation in vendor documentation.
What supplier list is practical for sourcing?
A practical target set for RFP outreach (based on allopurinol production footprint across major markets) includes:
- Sandoz
- Teva
- Dr. Reddy’s Laboratories
- Accord Healthcare
- Mylan (including Upjohn historical branding)
- Lupin
- Hikma
- Siegfried (where site-specific API/salt-form support applies)
Key Takeaways
- “Allopurinol sodium” is typically sourced through the broader allopurinol supplier universe, then validated with salt-form-specific CoA and analytical proof.
- Large generics and established API/formulation manufacturers are the most reliable starting points because they can support dossier-consistent naming and GMP documentation.
- Supplier qualification should hinge on salt identity confirmation, not only on allopurinol CAS presence.
FAQs
1) Can suppliers who make “allopurinol” also supply “allopurinol sodium”?
Yes, but only if they can document salt-form production and provide CoAs and specs that match the “sodium” salt form used in the intended regulatory context.
2) Are brand owners likely to supply “allopurinol sodium” directly as an API?
Brand owners and large generics typically supply finished products and may or may not supply API. For API/salt sourcing, the most direct pathway is through API houses or CMOs, with confirmation of the salt form.
3) Why does procurement often list “allopurinol” rather than “allopurinol sodium”?
Registration and labeling conventions commonly use the drug name “allopurinol,” even when salt forms are present in certain manufacturing or dosage contexts.
4) What is the fastest technical proof that a supplier has the right salt form?
A CoA that explicitly matches the salt form plus an analytical package consistent with that salt (assay/impurities and, where needed, solid-state characterization).
5) Which suppliers are most reliable for dossier-consistent salt naming?
Large, multi-jurisdiction generics and established API/formulation manufacturers with documented control over solids form and regulatory submissions.
References
[1] European Medicines Agency (EMA). European public assessment reports (EPAR) and product information for allopurinol-containing medicines. https://www.ema.europa.eu/
[2] U.S. FDA. Drugs@FDA (allopurinol products and labeling resources). https://www.accessdata.fda.gov/scripts/cder/daf/
[3] European Directorate for the Quality of Medicines (EDQM). European Pharmacopoeia monographs and quality standards for allopurinol. https://www.edqm.eu/
