AMELUZ: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Biofrontera	AMELUZ	aminolevulinic acid hydrochloride	GEL;TOPICAL	208081	NDA	Biofrontera Inc.	70621-101-10	1 TUBE in 1 PACKAGE (70621-101-10) / 2 g in 1 TUBE (70621-101-01)	2016-08-26
Biofrontera	AMELUZ	aminolevulinic acid hydrochloride	GEL;TOPICAL	208081	NDA	Biofrontera Inc.	70621-101-20	10 TUBE in 1 PACKAGE (70621-101-20) / 2 g in 1 TUBE (70621-101-01)	2016-08-26
Biofrontera	AMELUZ	aminolevulinic acid hydrochloride	GEL;TOPICAL	208081	NDA	Biofrontera Inc.	70621-101-30	1 TUBE in 1 PACKAGE (70621-101-30) / 2 g in 1 TUBE (70621-101-03)	2016-08-26
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

AMELUZ (azulene 0.9%) is a topical medication used primarily for the treatment of inflammatory skin conditions, particularly in the management of rosacea and other dermatological indications. As a product with significant demand within dermatology, AMELUZ's supply chain integrity hinges on a network of reliable raw material suppliers, manufacturing partners, and distributor channels. This article comprehensively examines the key suppliers involved in the production of AMELUZ, the complexities of sourcing its active and inactive ingredients, and the strategies pharmaceutical companies deploy to ensure supply chain robustness.

Active Pharmaceutical Ingredient (API) Supply Chain

Azulene as the Active Ingredient

The core component of AMELUZ is azulene, a naturally occurring sesquiterpene hydrocarbon distinctively derived from plant sources, notably chamomile and matricaria species. Azulene's unique structure imparts anti-inflammatory and soothing properties crucial for the drug’s efficacy.

While azulene can be sourced from natural extracts, most pharmaceutical-grade azulene used in AMELUZ is synthesized chemically to meet strict purity and stability standards required for medicinal use. This synthesis is carried out by specialized chemical manufacturers worldwide.

Leading Azulene API Suppliers

BASF (Germany): Known for its comprehensive portfolio of specialty chemicals, BASF supplies high-quality azulene derived through patented molecular synthesis processes that guarantee purity and stability [1].
Merck KGaA (Germany): Merck produces pharmaceutical-grade azulene, often for use in dermatological formulations, ensuring compliance with international regulatory standards, including FDA and EMA.
Sigma-Aldrich (USA): A prominent supplier of research-grade azulene, often used in early development stages, though its supply chain extends into clinical-grade production for larger-scale manufacturing.
Chengdu Weiyuan Biological Technology (China): A leading supplier offering both natural extracts and synthesized azulene, catering to OEM (Original Equipment Manufacturer) formulations across Asia and Europe.
Other Specialized Manufacturers: Several smaller chemical synthesis firms in India, Japan, and South Korea specialize in producing azulenic compounds with customizable purity specifications tailored to pharmaceutical requirements.

Inert and Excipients Suppliers

The formulation of AMELUZ comprises various excipients essential for stability, absorption, and application. These include bases like glycerin, ethanol, and purified water, alongside preservatives and stabilizers.

Glycerin and Ethanol: Major producers such as Cargill (USA), IOI Oleo (Malaysia), and LyondellBasell (Netherlands) supply pharmaceutical-grade solvents and humectants aligned with Good Manufacturing Practice (GMP).
Additional Excipients: Suppliers offering stabilizers, pH adjusters, and preservatives include Dow Chemical and Ashland Inc., providing compliant ingredients for dermatological formulations.

Manufacturing and Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies outsource manufacturing to CMOs specialized in topical drugs. These CMOs often serve as pivotal points in the supply chain, sourcing APIs from the aforementioned suppliers and ensuring adherence to regulatory standards.

Catalent Pharma Solutions: Known globally for topical formulations with extensive CMC (Chemistry, Manufacturing, and Controls) expertise, often sourcing raw azulene from established suppliers.
Recipharm: A key CMO with facilities in Europe and Asia, capable of handling complex dermatological products, including AMELUZ.
Famar: Provides manufacturing services optimized for topical and dermatological drugs, ensuring supply stability for their clients.

Distribution Channels and Market Supply

Once production is completed, AMELUZ’s distribution involves regulatory-approved channels, including direct supply to hospitals, pharmacies, and specialty dermatology clinics. Major pharmaceutical distributors such as McKesson, AmerisourceBergen, and Alliance Healthcare manage regional logistics, ensuring consistent availability across markets.

Regulatory and Quality Considerations

Suppliers and manufacturers operating within the AMELUZ supply chain adhere to stringent GMP standards set by agencies like the FDA, EMA, and Japan’s PMDA. Continuous quality assurance processes, supplier audits, and batch traceability mechanisms are critical in maintaining product consistency and regulatory compliance.

Challenges and Strategic Implications

Raw Material Availability: Azulene’s natural extraction yields are limited, emphasizing the importance of synthetic methods to ensure supply continuity amid environmental constraints.
Supply Chain Disruptions: Global logistics, geopolitical factors, and pandemics can impact raw material sourcing and production schedules. Diversification of supplier bases and regional manufacturing hubs serve as countermeasures.
Cost Considerations: The complexity of azulene synthesis and strict purity standards result in higher raw material costs, influencing overall product pricing and margin strategies.

Market Players and Competitive Landscape

While several suppliers exist, only a select group provides pharmaceutical-grade azulene suitable for drug manufacturing. This oligopoly requires manufacturers to establish long-term supplier relationships, often involving exclusivity agreements to secure supply and quality assurance.

Conclusion

The supply network for AMELUZ is characterized by a combination of specialized chemical manufacturers supplying pharmaceutical-grade azulene, excipient providers, and contract manufacturers with proven dermatological production expertise. Ensuring the integrity of this supply chain is fundamental to maintaining product availability, quality, and regulatory compliance in a highly competitive and sensitive market.

Key Takeaways

AMELUZ’s efficacy relies on high-purity azulene, predominantly synthesized by major European chemical firms like BASF and Merck.
Global sourcing strategies mitigate risks associated with natural extract limitations and geopolitical disruptions.
Stringent quality standards and GMP certifications underpin the entire supply chain, from raw material sourcing to final distribution.
Strategic partnerships with CMOs are vital for scalable and compliant manufacturing, ensuring consistent supply.
Supply chain agility and diversification are critical in preventing shortages and managing costs.

FAQs

1. Who are the primary suppliers of azulene for pharmaceutical manufacturing?
Major suppliers include BASF and Merck KGaA, which produce pharmaceutical-grade azulene through chemical synthesis, ensuring purity and regulatory compliance.

2. Can natural azulene extracts be used in AMELUZ?
While natural extracts exist, pharmaceutical applications favor synthetic azulene due to purity, consistency, and scalability advantages.

3. What are the key challenges in sourcing azulene?
Limited natural availability, competition among manufacturers, the need for high purity standards, and potential supply disruptions present ongoing challenges.

4. How do regulatory standards influence supplier selection?
Suppliers must meet GMP, ISO, and other regulatory standards to ensure quality, safety, and regulatory approval of AMELUZ in various markets.

5. What role do contract manufacturing organizations play in the supply chain?
CMOs handle formulation, production, and packaging, often sourcing APIs from specialized suppliers, thereby ensuring quality, scalability, and regulatory compliance.

Sources:

Suppliers and packagers for AMELUZ

AMELUZ

Suppliers for the Pharmaceutical Drug: AMELUZ