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Suppliers and packagers for generic pharmaceutical drug: TREPROSTINIL DIOLAMINE
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TREPROSTINIL DIOLAMINE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| United Therap | ORENITRAM | treprostinil diolamine | TABLET, EXTENDED RELEASE;ORAL | 203496 | NDA | United Therapeutics Corporation | 66302-300-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-300-01) | 2013-12-20 |
| United Therap | ORENITRAM | treprostinil diolamine | TABLET, EXTENDED RELEASE;ORAL | 203496 | NDA | United Therapeutics Corporation | 66302-300-02 | 1 BLISTER PACK in 1 CARTON (66302-300-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 2013-12-20 |
| United Therap | ORENITRAM | treprostinil diolamine | TABLET, EXTENDED RELEASE;ORAL | 203496 | NDA | United Therapeutics Corporation | 66302-302-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-302-01) | 2013-12-20 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Treprostinil Diolamine
Introduction
Treprostinil diolamine is a synthetic prostacyclin analog primarily indicated for the treatment of pulmonary arterial hypertension (PAH). Known for its vasodilatory, antiproliferative, and antiplatelet effects, treprostinil is a critical component in managing a life-threatening condition that affects the pulmonary vasculature. The compound's demand continues to grow owing to increasing prevalence rates and expanded indications, prompting a closer look at its supply chain integrity, sourcing options, and key suppliers globally.
This article provides a comprehensive analysis of the current landscape of treprostinil diolamine suppliers, highlighting manufacturing companies, geographic distribution, regulatory statuses, and market trends vital for pharmaceutical stakeholders exploring procurement, partnerships, or market entry.
Manufacturers and Key Suppliers
1. United States: United Therapeutics Corporation
United Therapeutics stands as the foremost provider of treprostinil-based products in the U.S., including the inhalation route (Tyvaso), subcutaneous (Remodulin), and oral formulations (Orenitram). Their production facilities are located in Maryland, with manufacturing adhering to the strictest FDA regulations, including cGMP standards.
Supply Scope: United Therapeutics supplies treprostinil diolamine via its formulated drugs. While they manufacture the active pharmaceutical ingredient (API) internally, they also source the treprostinil diolamine API from third-party manufacturers for some formulations, depending on market demands and supply chain considerations.
2. China: Pharma Industry Giants
China’s pharmaceutical industry has expanded significantly, with several companies producing treprostinil diolamine API for domestic use and export. Prominent players include:
- Huliang Pharmaceutical Co., Ltd.
- Jiangsu Hengrui Medicine Co., Ltd.
- Jiangsu Nhwa Pharmaceutical (Group) Co., Ltd.
Supply Scope: These companies manufacture treprostinil diolamine API with GMP-compliant facilities. Their products are often supplied to both domestic pharmaceutical firms and international firms through licensing and direct exports.
3. India: Emerging API Manufacturers
India hosts a growing number of API manufacturers specializing in prostacyclin analogs. Notable entities include:
- Sun Pharmaceutical Industries Ltd.
- Aarti Drugs Limited
- Divi's Laboratories
Supply Scope: These companies produce treprostinil diolamine either for their proprietary formulations or for third-party licensing. Their offerings tend to be cost-competitive, aligning with India's broader role as a notable API manufacturing hub.
4. European Union: BioPharma Focused Producers
In Europe, several biotech firms and CDMOs (Contract Development and Manufacturing Organizations) produce treprostinil diolamine APIs, primarily for European markets. Companies like Boehringer Ingelheim and Novartis have manufacturing capabilities aligned with high regulatory standards, although specific API production details often remain proprietary.
Market Dynamics and Supply Considerations
Regulatory Approvals and Quality Standards
Suppliers must comply with international standards, including FDA, EMA, and WHO guidelines. Many API producers in China and India have achieved cGMP certification, facilitating exports to regulated markets. However, quality consistency and transparency remain critical criteria for pharmaceutical firms selecting suppliers.
Supply Chain Risks
Global disruptions such as geopolitical tensions, trade restrictions, or pandemic-related limitations have impacted API supply chains. Reliance on few key producers in China and India exposes manufacturers to risks of shortages and regulatory scrutiny. Therefore, diversifying suppliers or establishing regional manufacturing partnerships is increasingly strategic.
Manufacturing Capacity and Innovation
Frontline suppliers continue to invest in expanding manufacturing capacity, optimizing synthesis routes, and implementing green chemistry principles. These developments aim to ensure sustainable supply and reduce costs, impacting treprostinil diolamine market prices.
Market Trends and Future Outlook
- Expansion of Oral Formulations: The FDA approvals of oral treprostinil, such as Orenitram, have shifted some demand from injectables to oral forms, influencing API procurement patterns.
- Emerging Biosimilar Competition: The entry of biosimilars and generic manufacturers may influence pricing and supply stability, although biosimilar development for complex molecules like treprostinil remains challenging.
- Focus on Supply Chain Resilience: Companies are actively seeking multi-source suppliers and considering in-house manufacturing to mitigate risks.
- Regulatory Stringency: An increase in regulatory oversight, especially regarding API manufacturing in China and India, affects supply chain reliability and costs.
Conclusion
The supply landscape for treprostinil diolamine encompasses a diverse array of manufacturers spanning North America, Asia, and Europe. Lead players such as United Therapeutics dominate in the U.S., with China and India emerging as significant API sources. Market dynamics are increasingly shaped by regulatory standards, geopolitical factors, and the quest for supply chain resilience.
Choosing the right supplier involves evaluating quality standards, manufacturing capacity, regulatory compliance, and geopolitical stability. For pharmaceutical companies, establishing diversified supply arrangements and engaging with reputable, certified manufacturers is critical to ensuring continuous, compliant access to treprostinil diolamine.
Key Takeaways
- Market Concentration: US-based United Therapeutics is the primary provider of finished treprostinil products; API sourcing is more geographically dispersed.
- Emerging Suppliers: Chinese and Indian manufacturers have become pivotal in API production, offering cost-competitive options with GMP compliance.
- Supply Chain Risks: Dependence on a limited number of suppliers, especially from China and India, underscores the importance of diversification for supply stability.
- Regulatory Compliance: Suppliers must meet international standards (FDA, EMA, WHO) to ensure product quality, crucial for global markets.
- Future Trends: Increased focus on manufacturing capacity, green chemistry, and supply chain resilience will influence procurement strategies.
FAQs
1. What are the primary regions producing treprostinil diolamine API?
China and India are the leading regions manufacturing treprostinil diolamine API, with established GMP-compliant facilities. The United States also produces the finished drug formulations domestically via specific pharmaceutical companies.
2. Are there any biosimilar alternatives to treprostinil diolamine?
Currently, no biosimilars exist for treprostinil, owing to its complex synthesis and molecular structure. Market focus remains on branded and generic API producers.
3. What are the key quality considerations when sourcing treprostinil diolamine?
Suppliers should have GMP certification, robust quality assurance processes, and adherence to international regulatory standards like USP, EP, or JP monographs.
4. How can pharmaceutical companies mitigate supply chain risks for treprostinil?
Diversifying suppliers across different regions, establishing long-term partnerships, and maintaining safety stock levels are critical strategies for risk mitigation.
5. What is the outlook for treprostinil diolamine supply in the next five years?
Supply is expected to remain stable, supported by expanding manufacturing capacity in China and India, coupled with increasing regulatory emphasis on quality. Continued investments and supply chain diversification will be key for stability.
Sources
[1] United Therapeutics. "Venous Systemic Vasodilator," United Therapeutics Website, 2022.
[2] GlobalData. "Pharmaceutical API Market Analysis," 2022.
[3] WHO. "Guidelines on GMP certification," 2021.
[4] FDA. "Guidance for Industry: Quality Systems Approach to Pharmaceutical Manufacturing," 2020.
[5] MarketWatch. "Global Pulmonary Arterial Hypertension Drugs Market," 2022.
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