Last updated: July 28, 2025
Introduction
LYSTEDA (tranexamic acid) is an FDA-approved medication indicated primarily for reducing heavy menstrual bleeding caused by uterine fibroids in women of reproductive age. As a specialized pharmaceutical product, its supply chain involves multiple stakeholders, including active pharmaceutical ingredient (API) manufacturers, formulation and packaging firms, and authorized distributors. Understanding the landscape of LYSTEDA suppliers is essential for stakeholders engaging in procurement, manufacturing, or competitive analysis within the pharmaceutical and healthcare sectors.
Manufacturers of LYSTEDA (Tranexamic Acid)
Active Pharmaceutical Ingredient (API) Suppliers
At the core of LYSTEDA's supply chain are companies producing tranexamic acid API. Several global and regional manufacturers supply this compound, either as proprietary entities or through licensing arrangements:
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BASF SE
As a leading global chemical company, BASF supplies tranexamic acid API to various pharmaceutical firms. BASF's extensive manufacturing capacity enables consistent supply and high purity standards, essential for pharmaceutical applications. Their API production meets stringent regulatory compliance, including EU-GMP and FDA standards.
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Sanofi (Formerly Sanofi-Aventis)
Sanofi possesses manufacturing capabilities for tranexamic acid API, often producing for internal use and contract manufacturing. The company's global footprint ensures reliable supply chains and quality controls.
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Fresenius Kabi
Known for producing injectable pharmaceuticals and APIs, Fresenius Kabi supplies tranexamic acid API to various markets, particularly in Europe and Asia. Their manufacturing facilities adhere to international quality standards.
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Shanghai Sinepharm Co., Ltd.
A notable Asian API producer offering tranexamic acid, supplying both generic and branded formulations. Their cost-effective production often serves emerging markets.
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Hubei Tianyan Pharmaceutical Co., Ltd.
Based in China, this firm manufactures tranexamic acid API primarily for domestic distribution and export, adhering to GMP guidelines.
Finished Dosage Formulators and Brand Owners
The approved drug LYSTEDA is marketed by Apotex Corp., a major North American generic and branded pharmaceutical manufacturer. Others may produce generic versions or similar formulations:
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Apotex Corp.
As the sole manufacturer of LYSTEDA in the United States, Apotex sources its API from multiple suppliers, potentially including the aforementioned producers, to ensure quality and supply security.
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Teva Pharmaceuticals
Although not an owner of LYSTEDA, Teva and other generic manufacturers distribute tranexamic acid in various forms, potentially including tablets similar to LYSTEDA, sourced from various API suppliers.
Supply Chain Dynamics
Regulatory & Quality Considerations
API suppliers for tranexamic acid must comply with regulatory standards like the FDA's Current Good Manufacturing Practice (cGMP) and European Medicines Agency (EMA) guidelines. High purity and consistent supply are paramount due to the medication's use in chronic and sensitive conditions.
Market Trends and Competition
The global demand for tranexamic acid, driven by its expanded use in trauma care, postpartum hemorrhage, and bleeding disorders, influences supplier activity. The surge in demand has spurred new entrants, especially from Asia, to enhance supply capacity.
Supply Chain Risks
Supply chain disruptions for LYSTEDA-related API can stem from geopolitical tensions, manufacturing compliance issues, or raw material shortages. Companies often mitigate risks via dual sourcing, inventory buffering, and quality audits.
Key Suppliers of the API for LYSTEDA
| Supplier |
Location |
Regulatory Status |
Capacity |
Key Markets Served |
Notes |
| BASF SE |
Germany |
GMP Certified |
High |
Global |
Leading global API supplier |
| Sanofi |
France |
GMP Certified |
Moderate |
Europe, Emerging Markets |
Integrated manufacturing |
| Fresenius Kabi |
Germany |
GMP Certified |
Moderate |
Europe, Asia |
Focus on injectables and APIs |
| Shanghai Sinepharm |
China |
GMP Certified |
Moderate |
Asia, Emerging Markets |
Cost-effective producer |
| Hubei Tianyan |
China |
GMP Certified |
Moderate |
Domestic, Export |
Growing presence |
Conclusion
The supply of LYSTEDA hinges on a diversified network of API manufacturers, primarily situated in Europe and Asia, with Apotex serving as the key marketed product owner in North America. As demand for tranexamic acid increases due to its therapeutic versatility, supply security depends on strategic sourcing, quality assurance, and proactive risk management. Stakeholders should continuously monitor API supplier compliance, capacity expansions, and geopolitical developments that might influence supply dynamics.
Key Takeaways
- Diverse API Suppliers: Major global players like BASF and regional producers in China and India supply tranexamic acid, ensuring competitive pricing and supply resilience.
- Regulatory Compliance: Suppliers must adhere to stringent pharmacopeial standards, influencing their qualification as LYSTEDA’s API sources.
- Market Expansion Drives Demand: The rising use of tranexamic acid beyond LYSTEDA broadens potential sourcing options, impacting supply chain strategies.
- Risk Management: Companies should implement dual sourcing and quality audits to mitigate potential disruptions.
- Strategic Partnerships: Collaborations with reputable API manufacturers can secure long-term supply and maintain product quality.
FAQs
1. Who are the primary manufacturers of tranexamic acid API used in LYSTEDA?
Major API producers include BASF SE, Sanofi, Fresenius Kabi, as well as several Chinese manufacturers like Shanghai Sinepharm and Hubei Tianyan Pharmaceutical.
2. Is LYSTEDA manufactured solely by Apotex?
Yes, Apotex is the exclusive manufacturer and marketer of LYSTEDA in the United States, sourcing API from multiple suppliers to ensure consistent quality and supply.
3. How do API suppliers ensure quality compliance for pharmaceutical-grade tranexamic acid?
They adhere to cGMP standards, perform rigorous quality control testing, and undergo regular audits by regulatory authorities such as the FDA and EMA.
4. Are there upcoming new suppliers or alternative sources for tranexamic acid?
Emerging suppliers from India and other Asian countries are expanding production capacities, potentially providing alternative sourcing options, contingent on regulatory approval and quality standards.
5. What factors influence the choice of API suppliers for LYSTEDA?
Supply chain stability, regulatory compliance, manufacturing capacity, product quality, and cost-effectiveness are key considerations influencing supplier selection.
Sources
[1] U.S. Food and Drug Administration. LYSTEDA (tranexamic acid) Detailed Prescribing Information.
[2] BASF Corporate Website. Tranexamic Acid API Overview.
[3] Sanofi Official Website. API Manufacturing Capabilities.
[4] Fresenius Kabi Product Portfolio.
[5] Industry Reports on Pharmaceutical API Market Dynamics and Trends.
