Last Updated: May 14, 2026

Suppliers and packagers for 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
Actavis Labs Ut Inc AZELAIC ACID azelaic acid GEL;TOPICAL 208011 ANDA Actavis Pharma, Inc. 0591-2131-55 1 TUBE in 1 CARTON (0591-2131-55) / 50 g in 1 TUBE 2018-11-19
Encube AZELAIC ACID azelaic acid GEL;TOPICAL 208724 ANDA Encube Ethicals, Inc. 21922-038-14 1 TUBE in 1 CARTON (21922-038-14) / 50 g in 1 TUBE 2023-11-30
Encube AZELAIC ACID azelaic acid GEL;TOPICAL 208724 ANDA Bryant Ranch Prepack 72162-2297-2 1 TUBE in 1 CARTON (72162-2297-2) / 50 g in 1 TUBE 2023-11-30
Glenmark Speclt AZELAIC ACID azelaic acid GEL;TOPICAL 204637 ANDA Glenmark Pharmaceuticals Inc., USA 68462-626-52 1 TUBE in 1 CARTON (68462-626-52) / 50 g in 1 TUBE 2018-11-19
Sun Pharma Canada AZELAIC ACID azelaic acid GEL;TOPICAL 210549 ANDA Sun Pharmaceutical Industries, Inc. 51672-1389-3 1 TUBE in 1 CARTON (51672-1389-3) / 50 g in 1 TUBE 2019-08-23
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

AZELAIC ACID: Key API and Specialty Supplier Landscape (Commercial Sources)

Last updated: April 23, 2026

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:

  1. Hangzhou Everlight Chemical Co., Ltd.
  2. Nantong Jiangshan Pharmaceutical Co., Ltd.
  3. Tianjin Huilong Chemical Co., Ltd.
  4. Keming Chemical Co., Ltd.
  5. Cangzhou Biomax Chemical Co., Ltd.
  6. Hubei Hongyuan Biotechnology Co., Ltd.
  7. 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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