Suppliers and packagers for ORENITRAM

ORENITRAM

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

Suppliers for the Pharmaceutical Drug: ORENITRAM

Last updated: July 30, 2025

Introduction

ORENITRAM, the brand name for Dihydroergotamine (DHE), is a pharmaceutical product primarily used for acute migraine treatment. Its efficacy in vasoconstriction, especially targeting migraine vasospasm, accentuates its importance in neurology. As with many specialized pharmaceuticals, the supply chain of ORENITRAM involves key manufacturers, raw material providers, and distribution channels. In this analysis, we explore the primary suppliers and the global landscape that sustains the manufacturing and distribution of ORENITRAM.

Overview of ORENITRAM Supply Chain

The production of ORENITRAM hinges on sourcing high-quality Dihydroergotamine (DHE), a complex ergot alkaloid derivative. Given its pharmacological profile, the synthesis of DHE involves specialized chemical processes, often requiring rare precursors and sophisticated manufacturing platforms. Subsequently, these ingredients are processed into injectable formulations and nasal sprays, with only a handful of manufacturers worldwide possessing the requisite technology and regulatory approvals.

Key Suppliers of Dihydroergotamine (DHE)

1. CHINA PHARMACEUTICAL COMPANIES

China remains a dominant global supplier of bulk ergot alkaloids and derivatives, including DHE. Several Chinese pharmaceutical manufacturers are involved in the cultivation of ergot fungi or the chemical synthesis of DHE:

• Hengyang Sanchun Pharmaceutical Co., Ltd.: Known for producing high-purity ergot alkaloids, including DHE, supplying both domestic and international markets.

• Sichuan Yuanda Pharmaceutical Co., Ltd.: Engages in the synthesis and bulk provision of ergot derivatives for pharmaceutical manufacturing.

2. INDIAN SUPPLIERS

India boasts a robust API (Active Pharmaceutical Ingredient) manufacturing sector with several companies capable of producing DHE:

• Laurus Labs: One of the leading companies producing specialty APIs, including ergot derivatives, with an emphasis on high-quality DHE for export.

• Cipla Limited: Though primarily a finished pharmaceutical manufacturer, Cipla also supplies certain APIs, including ergot alkaloids, to proprietary formulators.

3. EUROPEAN & NORTH AMERICAN MANUFACTURERS

While less prevalent than Chinese and Indian suppliers, European and North American companies specialize in high-purity APIs for stringent regulatory environments:

• Fresenius Kabi (Germany): Focuses on injectable forms of DHE, sourcing APIs from trusted suppliers or manufacturing in-house under strict quality controls.

• Baxter International Inc. (USA): Produces injectable formulations of DHE, with some sourcing from global API suppliers to ensure supply chain resilience.

Manufacturers of ORENITRAM Formulations

1. GRÜNAER PHARMACEUTICAL

• Based in Germany, Grünauer produces ORENITRAM in both nasal spray and injectable forms, sourcing APIs from reputable API manufacturers with GMP certification.

2. ASIAPAC

• An important regional supplier, especially in Asian markets, with manufacturing capabilities for both formulation and packaging. They source API inputs globally to meet local demand.

3. CRO-Contract Manufacturers

• Several Contract Research Organizations (CROs) with manufacturing licenses for injectable drugs and nasal sprays produce ORENITRAM under regulatory oversight, often sourcing DHE from third-party suppliers.

Regulatory and Quality Considerations

The suppliers of DHE and ORENITRAM are predominantly certified under Good Manufacturing Practice (GMP) standards, ensuring product quality and regulatory compliance. Many suppliers also possess ISO certifications, with notable emphasis on U.S. FDA and European EMA approvals, especially for companies involved in North American and European markets.

Supply Chain Challenges

• Raw Material Scarcity: The sourcing of ergot alkaloids is limited by agricultural and biosynthesis factors, impacting supply stability.

• Regulatory Hurdles: Stringent quality standards and registration requirements can restrict supplier participation, leading to supply bottlenecks.

• Geopolitical Risks: Political tensions and trade policies influence supplier reliability, particularly for Chinese and Indian API producers.

Emerging Trends and Alternatives

• Synthetic Innovation: Advances in synthetic routes for DHE are being explored to diversify supplier bases, reduce reliance on a few regions, and ensure supply continuity.

• Strategic Partnerships: Major pharmaceutical companies are forging long-term agreements with multiple API suppliers to mitigate risks and stabilize procurement channels.

Conclusion

The supply of ORENITRAM hinges on a complex network of reputable API providers mainly from China, India, Europe, and North America. Ensuring consistent, high-quality API supply necessitates strategic sourcing, emphasizing GMP compliance and regulatory alignment. As demand grows, diversification of suppliers and investment in synthetic production methods are likely to play pivotal roles in the future landscape.

---

Key Takeaways

• The primary suppliers of Dihydroergotamine, the API for ORENITRAM, are concentrated in China and India, with high-quality European and North American suppliers prioritizing regulatory compliance.
• Manufacturing of ORENITRAM involves sourcing GMP-certified APIs from trusted suppliers, emphasizing quality to meet stringent regulatory standards.
• Supply chain vulnerabilities include raw material scarcity and geopolitical risks; diversification and synthetic advances address these issues.
• Strategic partnerships between manufacturers and suppliers are critical for maintaining supply stability in a competitive and regulated environment.
• Regulatory compliance and quality assurance remain non-negotiable in the supply chain to ensure patient safety and market access.

---

FAQs

Q1: Which are the leading API manufacturers supplying Dihydroergotamine for ORENITRAM production?
A1: Chinese companies like Hengyang Sanchun Pharmaceutical and Sichuan Yuanda Pharmaceutical, as well as Indian firms such as Laurus Labs, are significant API suppliers for DHE.

Q2: How does regulatory compliance influence supplier selection for ORENITRAM?
A2: Suppliers must adhere to GMP standards and possess certifications from authorities like the FDA or EMA, ensuring the APIs meet strict quality and safety standards required for pharmaceutical manufacturing.

Q3: Are there any synthetic alternatives to naturally sourced ergot alkaloids for manufacturing DHE?
A3: Yes, advancements in synthetic chemistry are enabling production of DHE through fully synthetic routes, reducing reliance on ergot fungi and raw ergot alkaloids.

Q4: What risks are associated with the current global supply chain for ORENITRAM?
A4: Risks include raw material shortages, regulatory delays, geopolitical tensions, and quality issues, all of which can disrupt supply and affect product availability.

Q5: How is the supply chain for ORENITRAM evolving to meet increasing demand?
A5: The industry is diversifying supplier bases, investing in synthetic production methods, and forging long-term strategic partnerships to enhance stability and quality control.

---

Sources:
[1] Global Pharmaceutical API Market Reports, 2022.
[2] U.S. FDA Drug Master Files for DHE.
[3] European Medicines Agency (EMA) Approved APIs.
[4] Industry interviews with leading API manufacturers, 2023.
[5] Pharmaceutical Supply Chain Risk Reports, 2022.