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Suppliers and packagers for generic pharmaceutical drug: AZELAIC ACID
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AZELAIC ACID
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071 | NDA | LEO Pharma Inc. | 50222-303-50 | 1 CAN in 1 CARTON (50222-303-50) / 50 g in 1 CAN | 2018-10-01 |
| Leo Pharma As | FINACEA | azelaic acid | AEROSOL, FOAM;TOPICAL | 207071 | NDA | LEO Pharma Inc. | 50222-303-91 | 1 CAN in 1 CARTON (50222-303-91) / 15 g in 1 CAN | 2018-10-01 |
| Almirall | AZELEX | azelaic acid | CREAM;TOPICAL | 020428 | NDA | Almirall, LLC | 16110-869-30 | 1 TUBE in 1 CARTON (16110-869-30) / 30 g in 1 TUBE | 2018-09-24 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
AZELAIC ACID: Key API and Specialty Supplier Landscape (Commercial Sources)
Who supplies azelaic acid for pharmaceutical use?
Azelaic acid is sold globally as an established commodity chemical and as a pharmaceutical-grade active. Supplier roles typically split into (1) API manufacturers producing azelaic acid for drug/dermal finished forms and (2) specialty chemical distributors who source pharmaceutical-grade material for formulators and contract manufacturers.
Which suppliers are established providers of azelaic acid (API-grade / pharmaceutical-grade channel)?
The following supplier list reflects named, publicly listed sources for azelaic acid offerings and supply-to-industry positioning (API/specialty chemical grades used in dermato-cosmetic and pharmaceutical manufacture).
| Supplier / Company | Supplier type | What they sell (as publicly listed) | Common buyer fit |
|---|---|---|---|
| Hangzhou Everlight Chemical Co., Ltd. | Manufacturer | “Azelaic Acid” listed as a chemical product | API / specialty chemical procurement |
| Nantong Jiangshan Pharmaceutical Co., Ltd. | Chemical/pharma manufacturer | “Azelaic Acid” listed for industrial/pharma supply | API procurement via pharma-chemical channel |
| Tianjin Huilong Chemical Co., Ltd. | Manufacturer | “Azelaic Acid” listed as a chemical product | API / contract manufacturing support |
| Keming Chemical Co., Ltd. | Manufacturer | “Azelaic Acid” listed | Specialty chemical procurement |
| Cangzhou Biomax Chemical Co., Ltd. | Manufacturer | “Azelaic Acid” listed | API sourcing or dermal ingredient supply |
| Hubei Hongyuan Biotechnology Co., Ltd. | Manufacturer | “Azelaic Acid” listed | Specialty ingredient channel |
| TRIVENI CHEMICALS | Distributor/chemical supply | “Azelaic Acid” product listing | Procurement through chemical distribution |
| Siegfried? (No direct azelaic acid listing identified in provided sources) | Not included | Not used | Avoids unverified sourcing claims |
What material grades are typically offered for azelaic acid?
Most suppliers segment azelaic acid by purity and grade naming that map to pharmaceutical vs industrial usage. Commonly marketed options include:
- Pharmaceutical grade (or “pharma grade”) azelaic acid intended for regulated dermal formulations and API use
- Cosmetic/dermaceutical grade azelaic acid intended for topical finished products
- Industrial grade for non-pharma uses where purity specs are lower
In practice, drug makers and contract manufacturers qualify suppliers to internal specifications (assay, impurities, water content, and microbial specs), often using vendor COAs and independent testing.
How to evaluate azelaic acid suppliers for drug manufacturing
Drug supply buyers usually gate suppliers on three workstreams:
1) Regulatory and quality system alignment
- GMP capability or documented quality system for chemical-to-pharma supply
- Ability to provide COA per lot and traceability documentation
- Supply continuity (ability to maintain consistent specs batch-to-batch)
2) Specification control
Typical parameters suppliers can support (depending on grade):
- Assay / content
- Impurities profile (process-related impurities and related substances)
- Residual solvents (if relevant for the production route)
- Water content and physical specs (for formulation handling)
- Particle size (if supplied for dermal manufacturing needs)
3) Contracting and lead-time execution
- Confirm packaging format and MOQ (drums vs bags)
- Confirm standard lead times and logistics lanes
- Confirm whether the supplier can support change notifications (spec, site, process)
Where does azelaic acid sit in the supply chain?
Azelaic acid is widely available because it is produced at commercial scale. The procurement differentiator is not whether suppliers exist, but whether they supply a controlled, qualified grade suitable for regulated pharmaceutical manufacturing.
A practical buying strategy for drug makers is to:
- shortlist manufacturers first for control of spec and traceability
- use distributors only when they can pass through pharmaceutical-grade documentation and lot-level traceability
- qualify at least two sources where feasible to reduce supply risk
Selected sourcing routes used by buyers
While production routes vary by supplier, azelaic acid commercially comes from petrochemical or fermentation-adjacent feedstocks and is then purified into targeted grades. Buyers typically select suppliers based on demonstrated impurity profiles and process stability rather than the route name.
Key supplier shortlist (action-ready)
The following supplier entities have public product listings for “Azelaic Acid” and are commonly used as starting points for qualification:
- Hangzhou Everlight Chemical Co., Ltd.
- Nantong Jiangshan Pharmaceutical Co., Ltd.
- Tianjin Huilong Chemical Co., Ltd.
- Keming Chemical Co., Ltd.
- Cangzhou Biomax Chemical Co., Ltd.
- Hubei Hongyuan Biotechnology Co., Ltd.
- TRIVENI CHEMICALS
Key Takeaways
- Azelaic acid is supplied by a broad set of chemical manufacturers and specialty distributors; the differentiator is pharmaceutical-grade quality documentation and lot-level spec control.
- For pharma procurement, prioritize manufacturers that can provide GMP-aligned documentation, COA per lot, and a stable impurity profile.
- Build a two-source qualification plan because azelaic acid is a commodity chemical where continuity and spec consistency drive risk more than basic availability.
FAQs
1) Is azelaic acid available from pharmaceutical API suppliers?
Yes. Multiple manufacturers list azelaic acid for pharma and dermal manufacturing channels, typically with pharmaceutical-grade options.
2) What is the main procurement risk for azelaic acid?
Spec consistency and impurity profile alignment to finished-product requirements, not basic availability.
3) Should a pharma buyer use distributors or manufacturers?
Manufacturers are preferred for traceability and direct spec control; distributors can work if they provide lot-level COAs and documentation pass-through.
4) Do suppliers offer different grades of azelaic acid?
Yes. Azelaic acid is typically segmented into pharmaceutical/pharma grade, cosmetic/derm grade, and industrial grade.
5) What qualification artifacts matter most?
COA per lot, impurity/related substances profile, stability of specs over time, and documented quality system.
References
[1] Hangzhou Everlight Chemical Co., Ltd. (n.d.). Azelaic Acid product listing.
[2] Nantong Jiangshan Pharmaceutical Co., Ltd. (n.d.). Azelaic Acid product listing.
[3] Tianjin Huilong Chemical Co., Ltd. (n.d.). Azelaic Acid product listing.
[4] Keming Chemical Co., Ltd. (n.d.). Azelaic Acid product listing.
[5] Cangzhou Biomax Chemical Co., Ltd. (n.d.). Azelaic Acid product listing.
[6] Hubei Hongyuan Biotechnology Co., Ltd. (n.d.). Azelaic Acid product listing.
[7] TRIVENI CHEMICALS. (n.d.). Azelaic Acid product listing.
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