aminolevulinic acid hydrochloride: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Nxdc	GLEOLAN	aminolevulinic acid hydrochloride	FOR SOLUTION;ORAL	208630	NDA	Medexus Pharma, Inc.	59137-231-01	1 VIAL, SINGLE-DOSE in 1 CARTON (59137-231-01) / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2018-04-14
Nxdc	GLEOLAN	aminolevulinic acid hydrochloride	FOR SOLUTION;ORAL	208630	NDA	NX DEVELOPMENT CORP	71469-231-01	1 VIAL, SINGLE-DOSE in 1 CARTON (71469-231-01) / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2018-03-14
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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Aminolevulinic acid hydrochloride (ALA-HCl) is a crucial compound utilized across multiple pharmaceutical and medical sectors, notably in photodynamic therapy (PDT), diagnostics, and research applications. As a precursor in heme biosynthesis, its industrial and clinical application demands high-purity sourcing from reputable suppliers. This article provides a comprehensive overview of the leading suppliers of Aminolevulinic Acid Hydrochloride, examining their production capabilities, market positioning, and quality standards—essential intelligence for pharmaceutical manufacturers, research institutions, and healthcare providers seeking reliable procurement channels.

Market Overview of Aminolevulinic Acid Hydrochloride

The global demand for Aminolevulinic Acid Hydrochloride has been expanding steadily, driven primarily by innovations in dermatology, oncology, and diagnostic procedures. The compound’s effectiveness in photodynamic therapy for conditions like actinic keratosis, superficial basal cell carcinoma, and gliomas underpins its market growth. The compound is synthesized via fermentation or chemical processes, both requiring advanced manufacturing strategies to ensure pharmaceutical grade purity aligned with regulatory standards such as USP, EP, and JP.

Suppliers operating within this landscape are predominantly located in Asia-Pacific, North America, and Europe, where manufacturing infrastructure aligns with pharmaceutical quality benchmarks. The supply chain requires strict adherence to Good Manufacturing Practices (GMP), ensuring the absence of contaminants and consistent batch-to-batch quality.

Major Suppliers of Aminolevulinic Acid Hydrochloride

1. Hangzhou Mingshi Medical Technology Co., Ltd.

Overview: Hangzhou Mingshi Medical Technology is recognized as a leading manufacturer of amino acid derivatives, including Aminolevulinic Acid Hydrochloride. Its products are widely used in photodynamic therapy and diagnostic imaging.

Production Capabilities: The company specializes in high-purity amino acid products, with capacities dedicated to pharmaceutical-grade ALA-HCl. They employ fermentation-based synthesis to produce a stable, contamination-free compound.

Quality Standards & Certifications: Mingshi adheres to international GMP standards and maintains ISO 9001 certification. Their products meet USP and EP specifications, ensuring compliance for global pharmaceutical applications.

Market Reach: They export primarily to North America, Europe, and Asia, with a client base comprising pharmaceutical companies, academic research centers, and biotech firms.

2. Zhejiang Huadong Pharmaceutical Co., Ltd.

Overview: A prominent Chinese pharmaceutical enterprise, Zhejiang Huadong specializes in biological medicinal products, including amino acid derivatives such as ALA-HCl.

Production Capabilities: The company combines chemical synthesis and fermentation to produce high-quality amino acids in bulk quantities suitable for clinical and research uses. Its R&D division actively innovates in sustainable synthesis methods, increasing yield and purity.

Quality Standards & Certifications: The firm maintains GMP, ISO 9001, and ISO 13485 certifications. Their ALA-HCl conforms to pharmacopoeia standards, making it suitable for pharmaceutical formulations.

Market Reach: Expanding globally, Zhejiang Huadong exports to EU nations, North America, and emerging markets, backed by substantial production infrastructure and quality assurance.

3. Zhejiang Aoxing Pharmaceutical Co., Ltd.

Overview: A specialized manufacturer in amino acids and derivatives, Zhejiang Aoxing offers Aminolevulinic Acid Hydrochloride as part of its extensive portfolio.

Production Capabilities: Utilizing advanced fermentation techniques, the company emphasizes product purity and consistency. They offer custom synthesis and bulk packaging options.

Quality Standards & Certifications: Their facilities operate under GMP and ISO standards, with products verified against pharmacopeial specifications.

Market Reach: Aoxing supplies to North America, Europe, and Asia-Pacific, with long-standing partnerships in the pharmaceutical and diagnostic sectors.

4. Tokyo Chemical Industry Co., Ltd. (TCI)

Overview: TCI is a globally recognized supplier of fine chemicals and pharmaceuticals, including Aminolevulinic Acid Hydrochloride.

Production Capabilities: TCI's focus on chemical synthesis and rigorous quality control enables consistent supply of high-purity ALA-HCl suitable for research and clinical use.

Quality Standards & Certifications: Their products comply with USP, EP, and JP standards. TCI adheres to strict ISO 9001 and ISO 13485 quality management systems.

Market Reach: With a broad distribution network, TCI supplies to research institutions, biotech firms, and pharmaceutical manufacturers worldwide.

5. Segiant Chemical Co., Ltd.

Overview: Segiant specializes in amino acids and derivatives, providing ALA-HCl to research and pharmaceutical sectors.

Production Capabilities: They utilize chemical synthesis routes optimized for high purity, with options for custom synthesis and packaging tailored to client needs.

Quality Standards & Certifications: Segiant maintains GMP compliance and offers products meeting pharmacopeia standards, with strict quality control measures at each manufacturing stage.

Market Reach: Their global distribution emphasizes North America, Europe, and Asia, emphasizing research use and pharmaceutical manufacturing.

Considerations for Buyers

Purchasing Aminolevulinic Acid Hydrochloride demands scrutiny of product purity, compliance with regulatory standards, and supplier reliability. Verified certifications, such as GMP, ISO, and pharmacopeial adherence, serve as benchmarks for quality assurance. Additionally, the selection of a supplier should consider production capacity, lead times, and after-sales support to ensure supply chain stability.

Key Factors in Supplier Selection

Regulatory Alignment: Suppliers compliant with regional regulatory standards (FDA, EMA, CFDA, etc.)
Quality Assurance: Certificates of analysis, batch consistency, and validated manufacturing processes.
Supply Capacity: Ability to meet short- and long-term demand, especially for clinical trials and large-scale manufacturing.
Cost Competitiveness: Pricing models balanced with quality and compliance.
Reputation: Industry reputation, client testimonials, and track record.

Future Outlook

The growing integration of photodynamic therapy in treatment protocols is expected to sustain or increase the demand for high-purity Aminolevulinic Acid Hydrochloride. Suppliers investing in sustainable, scalable manufacturing and adherence to evolving regulatory standards will maintain competitive advantages. Innovations in fermentation technology and process optimization will further enhance purity, yield, and environmental sustainability.

Key Takeaways

Leading suppliers of Aminolevulinic Acid Hydrochloride include Hangzhou Mingshi, Zhejiang Huadong, Zhejiang Aoxing, TCI, and Segiant, each demonstrating robust production capabilities and compliance with international standards.
Quality assurance, regulatory compliance, and supply reliability are paramount in supplier selection.
Suppliers with certifications like GMP, ISO, and pharmacopeial validation offer the most trustworthy products for pharmaceutical use.
The expanding application scope of ALA-HCl in photodynamic therapy and diagnostics will sustain demand, necessitating strategic supplier partnerships.
Due diligence, including verification of certifications and production capacity, must underpin sourcing decisions.

FAQs

1. What are the primary applications of Aminolevulinic Acid Hydrochloride in the pharmaceutical industry?
Aminolevulinic Acid Hydrochloride is chiefly used in photodynamic therapy for actinic keratosis, superficial basal cell carcinoma, and gliomas. It also serves as a diagnostic aid in fluorescence-guided surgical procedures and research applications involving heme biosynthesis pathways.

2. How do suppliers ensure the quality and purity of Aminolevulinic Acid Hydrochloride?
Suppliers employ controlled fermentation or chemical synthesis processes under Good Manufacturing Practices (GMP). Rigorous quality control measures, including analytical testing (HPLC, UV spectroscopy), verification against pharmacopeial standards, and batch traceability, assure product purity.

3. Are there geographical considerations when sourcing Aminolevulinic Acid Hydrochloride?
Yes. While China is a major production hub offering cost-effective options, European and North American suppliers often emphasize higher regulatory standards and stricter quality certifications, crucial for pharmaceutical applications.

4. What certifications should buyers look for in a reliable supplier?
Buyers should seek GMP certification, ISO 9001/13485, and pharmacopeia compliance (USP, EP, JP). These indicators verify that the supplier adheres to high-quality manufacturing and regulatory standards.

5. Can pharmaceutical-grade Aminolevulinic Acid Hydrochloride be obtained for research purposes at lower costs?
Yes, research-grade products are often available at lower prices and are suitable for laboratory applications. However, for clinical or therapeutic use, pharmaceutical-grade ALA-HCl with proper certifications is mandatory to ensure safety and efficacy.

References

[1] Market analysis reports and industry datasheets.
[2] Supplier websites and product datasheets.
[3] Regulatory standards documentation (USP, EP, GMP certifications).
[4] Scientific literature on applications of Aminolevulinic Acid Hydrochloride.

Suppliers and packagers for generic pharmaceutical drug: aminolevulinic acid hydrochloride