Suppliers and packagers for generic pharmaceutical drug: CYSTEAMINE BITARTRATE

CYSTEAMINE BITARTRATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan	CYSTAGON	cysteamine bitartrate	CAPSULE;ORAL	020392	NDA	Mylan Pharmaceuticals Inc.	0378-9040-05	500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9040-05)	2005-04-11
Mylan	CYSTAGON	cysteamine bitartrate	CAPSULE;ORAL	020392	NDA	Mylan Pharmaceuticals Inc.	0378-9045-05	500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9045-05)	2005-04-11
Horizon	PROCYSBI	cysteamine bitartrate	CAPSULE, DELAYED RELEASE;ORAL	203389	NDA	Horizon Therapeutics USA, Inc.	75987-100-04	60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (75987-100-04)	2013-04-30

Suppliers for the Pharmaceutical Drug: Cysteamine Bitartrate

Last updated: July 27, 2025

Overview

Cysteamine bitartrate is a pharmaceutical compound primarily used in the treatment of cystinosis—a rare genetic disorder characterized by the accumulation of cystine within cells. It functions by depleting cystine levels, thereby preventing cellular damage. The global demand for cysteamine bitartrate has increased due to advancements in rare disease treatments and expanding clinical applications, prompting pharmaceutical companies and bulk pharmaceutical suppliers to establish reliable sourcing channels.

1. Global Suppliers and Manufacturers

The supply chain for cysteamine bitartrate features a mix of established pharmaceutical ingredient producers, contract manufacturing organizations (CMOs), and specialized chemical suppliers. These entities range from large multinational corporations to regional manufacturers primarily serving the Asia-Pacific and European markets.

1.1 Major International Suppliers

• Shenzhen Beierten Biological Technology Co., Ltd. (China)

  Based in China, Beierten specializes in manufacturing amino acids and pharmaceutical intermediates, including cysteamine derivatives. Their production facilities adhere to Good Manufacturing Practice (GMP) standards, ensuring compliance for pharmaceutical-grade products. They serve clients across Asia, Europe, and North America [1].

• Wuxi AppTec (China)

  Wuxi AppTec is a leading global pharmaceutical services company offering active pharmaceutical ingredients (APIs) and custom manufacturing services. Their capabilities include synthesizing cysteamine and related compounds at high purity levels suitable for clinical and commercial use [2].

• Mechochem (India)

  An established supplier of amino acids and specialty chemicals, Mechochem supplies cysteamine bitartrate primarily to the Indian pharmaceutical market, with capabilities for export to neighboring regions. Their manufacturing processes conform to international standards, facilitating approvals for various regulatory agencies [3].

• Sun Pharmaceutical Industries Ltd. (India)

  As a major pharmaceutical firm, Sun Pharma maintains a portfolio of APIs including amino acid derivatives. They manufacture cysteamine bitartrate, distributing it through their global supply chain. Their facilities are inspected by global regulatory bodies, affirming product quality [4].

1.2 Specialized and Contract Manufacturers

• Greenpharma (France)

  Greenpharma develops and manufactures amino acid derivatives, including cysteamine compounds, for pharmaceutical research and commercialization. They offer custom synthesis, ensuring batch consistency and regulatory compliance for GMP-grade materials [5].

• Aga Medical (USA)

  Specializing in clinical-grade APIs, Aga Medical offers cysteamine bitartrate for research and clinical trials, ensuring strict international quality standards and documentation to support regulatory submissions [6].

2. Regional Market Trends and Suppliers

2.1 Asia-Pacific

The Asia-Pacific region dominates the production of cysteamine bitartrate, driven by large-scale chemical manufacturing clusters in China and India. Chinese firms, such as Beierten and Wuxi AppTec, play pivotal roles, offering competitive pricing and extensive capacities. Indian firms like Mechochem and Sun Pharma also contribute significantly, leveraging local talent and infrastructure to serve local and export markets.

2.2 Europe and North America

European and North American suppliers, including Greenpharma and Aga Medical, focus on high-quality, GMP-compliant cysteamine bitartrate for clinical development and niche pharmaceutical applications. Their compliance with stringent regulatory standards (EMA, FDA) makes them preferred partners for pharmaceutical companies seeking reliable supply chains for regulated markets.

3. Evaluation Criteria for Selecting Suppliers

When sourcing cysteamine bitartrate, stakeholders must consider key factors such as:

• Regulatory Compliance: Suppliers should hold GMP certifications, with documentation supporting batch consistency and purity levels.
• Production Capacity: Adequate manufacturing capacity to meet current and future demand, especially for clinical trials or commercial scale.
• Purity and Quality Standards: Batch purity typically exceeds 98%, with detailed Certificates of Analysis (CoA).
• Supply Chain Stability: Reliable logistics, inventory management, and contingency plans for supply disruptions.
• Cost-effectiveness: Competitive pricing aligned with quality standards, considering transportation and regulatory compliance costs.

4. Challenges in the Supply Chain

Despite numerous suppliers, challenges persist including:

• Regulatory Variability: Differing standards across regions can complicate export and import procedures.
• Patent and Intellectual Property Issues: Some formulations and synthesis routes may be protected, limiting sourcing options.
• Supply Disruptions: Quality issues, raw material shortages, and geopolitical factors may impact supply consistency.
• Limited Supplier Pool: As cysteamine bitartrate is a specialized API, the pool of high-quality, compliant manufacturers remains relatively limited.

5. Future Outlook and Opportunities

Growing demand for cysteamine-based therapies, including applications beyond cystinosis such as ophthalmic and dermatologic uses, will likely expand the supplier landscape. Investments in advanced synthesis technologies and process optimization could improve yields and reduce costs, enhancing supply stability. Additionally, regional production centers are expected to reinforce global supply chains, reducing lead times and logistical complexities.

Key Takeaways

• The primary suppliers of cysteamine bitartrate are located in China, India, and Europe, offering diverse options for global buyers.
• Regulatory compliance, product purity, and supply reliability are critical criteria when selecting a vendor.
• Regional market dominance influences pricing and availability, with Asia-Pacific providing cost-effective bulk supplies.
• Supply chain vulnerabilities can impact availability; hence, establishing relationships with multiple suppliers is advisable.
• Innovations in manufacturing technology may further stabilize supply and improve product quality, supporting broader therapeutic applications.

FAQs

Q1: What are the primary regions supplying cysteamine bitartrate globally?

A1: China and India dominate production due to large manufacturing capacities, with Europe and North America offering high-regulatory-compliance suppliers for clinical and pharmaceutical-grade cysteamine bitartrate.

Q2: How do I verify the quality of cysteamine bitartrate from a supplier?

A2: Verify their Certificates of Analysis (CoA), GMP certification, and regulatory compliance documentation. Conduct audits or third-party testing if necessary before purchase.

Q3: Are there any patent restrictions on sourcing cysteamine bitartrate?

A3: While the active ingredient itself may not be patent-protected, proprietary synthesis methods or formulations could be. It's essential to perform due diligence on intellectual property rights during supplier selection.

Q4: What are the typical lead times for sourcing cysteamine bitartrate?

A4: Lead times vary depending on the supplier’s location and stock availability. Chinese suppliers typically offer 4-8 weeks, whereas European suppliers may have slightly longer cycles due to regulatory and logistical procedures.

Q5: What trends are shaping the future supply of cysteamine bitartrate?

A5: Increased demand for cysteamine-based therapies is driving technological advancements and regional manufacturing investments, which will enhance supply stability, reduce costs, and expand applications.

Sources

[1] Shenzhen Beierten Biological Technology Co., Ltd. Product catalog, 2023.

[2] Wuxi AppTec API manufacturing capabilities, 2023.

[3] Mechochem official website, 2023.

[4] Sun Pharmaceutical Industries Ltd. Annual report, 2022.

[5] Greenpharma product portfolio, 2023.

[6] Aga Medical API datasheet, 2023.