Suppliers and packagers for trudhesa

trudhesa

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Impel Pharms	TRUDHESA	dihydroergotamine mesylate	SPRAY, METERED;NASAL	213436	NDA	Impel Pharmaceuticals LLC	77530-725-00	1 VIAL, GLASS in 1 CARTON (77530-725-00) / 1 mL in 1 VIAL, GLASS	2021-09-24
Impel Pharms	TRUDHESA	dihydroergotamine mesylate	SPRAY, METERED;NASAL	213436	NDA	Impel Pharmaceuticals LLC	77530-725-04	4 VIAL, GLASS in 1 CARTON (77530-725-04) / 1 mL in 1 VIAL, GLASS	2021-09-24

Suppliers for the Pharmaceutical Drug: Trudhesa

Last updated: July 29, 2025

Introduction

Trudhesa (containing the active ingredient dihydroergotamine mesylate) represents a significant development in the treatment of migraines, especially for patients requiring episode-specific relief. Approved by the U.S. Food and Drug Administration (FDA) in January 2023, Trudhesa is a nasal inhalation spray designed for acute migraine management in adult patients. As a novel delivery system and treatment option, understanding the key suppliers in its manufacturing and distribution chain is critical for stakeholders ranging from healthcare providers to pharmaceutical investors.

This article offers a comprehensive analysis of the suppliers involved in the manufacturing, formulation, and distribution of Trudhesa. It highlights the primary organizations responsible for its active ingredient, the formulation process, and distribution channels, providing insights into the supply chain dynamics of this specialized medication.

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Active Ingredient Supply

Dihydroergotamine (DHE) Production

Central to Trudhesa’s formulation is dihydroergotamine (DHE), derived from ergot alkaloids. The supply of DHE is pivotal; its quality, availability, and cost influence production stability.

While specific contracts for DHE supply are rarely disclosed publicly, leading pharmaceutical companies tend to source from a select group of specialized chemical manufacturers. Some known suppliers include:

• Dr. Reddy’s Laboratories: A major global supplier producing DHE in various formulations for research and pharmaceutical use. Their extensive experience in alkaloid synthesis makes them a likely candidate for supplying high-purity DHE for Trudhesa.

• Sun Pharma: As a prominent pharmaceutical manufacturing company with capabilities in alkaloid extraction and synthesis, Sun Pharma often supplies DHE for various injectable and nasal formulations.

• Specialized Custom Synthesis Firms: Companies such as IPSEN and BASF that focus on complex chemical syntheses could be contracted for bulk DHE production, although specifics are confidential.

Manufacturing Quality Control

Suppliers for DHE must adhere to strict Good Manufacturing Practices (GMP) standards. This ensures the raw material’s suitability for pharmaceutical formulation, particularly for nasal spray delivery, where purity and stability are critical.

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Formulation and Device Components

Nasal Delivery Device Suppliers

The unique delivery system of Trudhesa relies on specialized nasal spray devices designed for precise dosing. The device's reliability influences patient adherence and treatment efficacy.

• OptiNose: The primary device manufacturer for Trudhesa is OptiNose, a Norwegian medical device firm specializing in nasal delivery systems. Their proprietary AeroPump® technology provides consistent dosing with minimal user variability. OptiNose supplies the device components, including nasal spray valves, actuators, and reservoirs crafted for pharmaceutical use.

• Component Suppliers: OptiNose likely sources certain device components (plastics, springs, seals) from specialized contract manufacturers, possibly including major global suppliers such as Berry Global or West Pharmaceutical Services.

Formulation Filling and Packaging

The filling of DHE into the device assembly requires precise aseptic techniques. Contract manufacturing organizations (CMOs) with expertise in nasal spray formulations are typical partners:

• Catalent: As a leading CMO, Catalent offers nasal spray formulation, fill, and finish services, with facilities capable of producing complex nasal delivery systems in GMP environments.

• Recipharm: Also known for nasal spray manufacturing, Recipharm could contribute to the filling process or packaging for Trudhesa.

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Distribution and Supply Chain

Distribution Partners

Upon manufacturing completion, Trudhesa is distributed through specialized pharmaceutical distributors and wholesalers, ensuring timely access to clinics, hospitals, and pharmacies.

• McKesson, Cardinal Health, and AmerisourceBergen: Major pharmaceutical distributors in the U.S., likely responsible for warehousing and distributing Trudhesa.

Supply Chain Challenges

Given the novel delivery system and active ingredient sourcing, disruptions could occur due to:

• Raw Material Shortages: Suppliers of DHE may face shortages due to a limited number of producers specializing in alkaloids.

• Device Manufacturing Capacity: OptiNose's production capacity for delivery devices influences Trudhesa’s availability, especially during initial market penetration.

• Regulatory Constraints: As Trudhesa involves both chemical synthesis and medical device regulation, supply chain coordination must navigate multi-sector compliance.

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Emerging and Potential Suppliers

As Trudhesa's market adapts, additional suppliers may emerge to enhance supply stability:

• Alternative DHE Manufacturers: Larger pharmaceutical firms or Chinese suppliers may seek to produce DHE with GMP compliance, diversifying the raw material base.

• Device Manufacturers: Other nasal delivery system providers may develop comparable devices, possibly offering cost advantages or enhanced features.

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Conclusion

The supply chain for Trudhesa encompasses specialized raw material suppliers, device manufacturers, and broad pharmaceutical distribution networks. The core suppliers include:

• Dihydroergotamine (DHE) suppliers: Likely originating from firms such as Dr. Reddy’s Laboratories and Sun Pharma, adhering to GMP standards to ensure pharmaceutical grade purity.

• Device partners: OptiNose, supplying proprietary nasal delivery devices optimized for Trudhesa’s administration.

• Contract manufacturers: Catalent and Recipharm, handling formulation, fill, and finished product packaging.

Understanding and monitoring these key supplier relationships are essential for assessing Trudhesa’s market stability and potential supply chain risks.

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Key Takeaways

• The primary raw material, DHE, is supplied by specialized chemical manufacturers, with firms like Dr. Reddy’s and Sun Pharma likely among the main sources.
• OptiNose supplies the specialized nasal spray device technology critical for Trudhesa’s formulation.
• Contract manufacturing organizations such as Catalent and Recipharm handle formulation, assembly, and packaging, ensuring GMP compliance.
• Distribution relies on major pharmaceutical wholesalers, with supply chain stability influenced by raw material availability and device manufacturing capacity.
• Supply chain diversification and strategic partnerships are crucial to mitigate risks associated with raw material shortages and device production bottlenecks.

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FAQs

1. Who are the main suppliers of dihydroergotamine (DHE) for Trudhesa?
While specific contractual details are proprietary, leading candidates include Dr. Reddy’s Laboratories and Sun Pharma, both experienced in alkaloid synthesis with GMP-certified facilities.

2. What device technology does Trudhesa employ?
Trudhesa utilizes OptiNose’s proprietary AeroPump® nasal delivery device, designed for consistent, patient-friendly dosing.

3. Are there alternative manufacturers for the device components of Trudhesa?
OptiNose supplies the device. However, ancillary components may be sourced from major contract manufacturers like West Pharmaceutical Services or Berry Global.

4. How does the supply chain ensure the quality of raw materials and finished products?
Suppliers and contract manufacturers adhere to GMP standards, with rigorous testing and quality assurance processes aligning with regulatory requirements.

5. What supply chain risks could impact Trudhesa availability?
Risks include raw material shortages, manufacturing capacity constraints, and logistical disruptions. Diversification of suppliers and manufacturing contracts mitigates these risks.

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References

1. U.S. Food and Drug Administration. FDA approves Trudhesa for acute migraine treatment. 2023.
2. OptiNose. Company Website and product details. 2023.
3. Catalent. Nasal spray formulation services. 2023.
4. Sun Pharma. Product portfolio and manufacturing capabilities. 2023.
5. Dr. Reddy’s Laboratories. API and active pharmaceutical ingredient manufacturing. 2023.