Suppliers and packagers for daliresp

daliresp

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522	NDA	AstraZeneca Pharmaceuticals LP	0310-0088-28	1 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0088-28) / 28 TABLET in 1 BLISTER PACK	2015-07-01
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522	NDA	AstraZeneca Pharmaceuticals LP	0310-0088-39	10 BLISTER PACK in 1 BOX, UNIT-DOSE (0310-0088-39) / 2 TABLET in 1 BLISTER PACK	2015-07-01
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522	NDA	AstraZeneca Pharmaceuticals LP	0310-0095-30	30 TABLET in 1 BOTTLE, PLASTIC (0310-0095-30)	2015-07-01
Astrazeneca	DALIRESP	roflumilast	TABLET;ORAL	022522	NDA	AstraZeneca Pharmaceuticals LP	0310-0095-90	90 TABLET in 1 BOTTLE, PLASTIC (0310-0095-90)	2015-07-01

Suppliers for the Pharmaceutical Drug: Daliresp (Roflumilast)

Last updated: July 27, 2025

Introduction

Daliresp, with the active pharmaceutical ingredient (API) roflumilast, is a prescription drug primarily used to manage chronic obstructive pulmonary disease (COPD). Developed and marketed by AstraZeneca, Daliresp is a phosphodiesterase-4 (PDE4) inhibitor that reduces inflammation in the lungs, improving breathing for patients with severe COPD and chronic bronchitis. The global nature of pharmaceutical manufacturing necessitates a robust understanding of key suppliers involved at various stages, from raw material sourcing to active pharmaceutical ingredient (API) production and finished dosage form (FDF) manufacturing.

This analysis explores the landscape of suppliers for Daliresp, detailing upstream raw material providers, API manufacturers, formulation partners, and distribution channels within the pharmaceutical supply chain. Understanding these suppliers' roles and strategic relationships informs stakeholders' procurement decisions, risk management, and market access strategies.

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Raw Material Suppliers for Roflumilast API

1. Chemical Precursors and Intermediates

Manufacturing roflumilast begins with sourcing high-purity chemical precursors essential for synthesis. The raw materials are often complex heterocyclic compounds requiring meticulous quality control. Major chemical suppliers for these intermediates include:

• BASF SE: A global chemical giant providing a broad spectrum of pharmaceutical intermediates and specialty chemicals. BASF supplies intermediates relevant to the synthesis of heterocyclic compounds similar to those in roflumilast. [1]

• Sigma-Aldrich (Merck Group): Offers a wide range of raw chemicals and building blocks for pharmaceutical synthesis, including halogenated aromatic compounds, which may be used in the early stages of API synthesis. Their products are ISO-certified, ensuring batch-to-batch consistency. [2]

• Toronto Research Chemicals (TRC): Specialized in providing high-grade pharmaceutical-grade intermediates. TRC supplies specific chemical building blocks used in complex API synthesis pathways, including heterocycles integral to roflumilast formulation. [3]

2. Specialty Chemical Suppliers for Synthesis

Developing efficiency in the synthesis process often involves sourcing specialty chemicals from established chemical providers:

• Lanxess AG: Offers a range of specialty chemicals and solvents, crucial for reactions during API manufacturing. These include solvents with high purity standards needed to meet strict pharmaceutical regulations. [4]

• Midland Chemical Co.: Supplies active pharmaceutical intermediates and solvents, focusing on compliance with pharmaceutical Good Manufacturing Practices (GMP). Their high-purity chemicals support scalable manufacturing.

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Active Pharmaceutical Ingredient (API) Manufacturers

1. Contract Manufacturing Organizations (CMOs)

Given the increasing trend of outsourcing API production to specialized CMOs, several entities manufacture roflumilast or possess the capacity to do so:

• Idorsia Pharmaceuticals: A Swiss company specializing in innovative pharmaceuticals, including finishing and packaging of roflumilast. Their manufacturing plants in Europe comply with strict GMP standards, ensuring quality and regulatory compliance. [5]

• Dr. Reddy's Laboratories: An established Indian CMO with capabilities for complex chemical synthesis, including customized API manufacturing. Dr. Reddy’s brings cost advantages and GMP compliance to the supply chain. [6]

• Jubilant HollisterStier (JHS): A North American CMO specializing in solid-dose manufacturing but also involved in API synthesis and supply for select APIs like roflumilast under collaborative agreements. [7]

2. In-House API Production

AstraZeneca, the originator of Daliresp, manufactures the API in-house at their specialized facilities to maintain control over quality and supply chain integrity.

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Formulation and Finished Product Manufacturing

Post-API manufacturing, Daliresp is formulated into tablets, requiring specialized excipients and coating materials sourced from global suppliers:

• Prime Pharma Ingredients: Supplying excipients including fillers, binders, and disintegrants compatible with Daliresp tablets.

• Croda International: Provides pharmaceutical-grade coating solutions to ensure stability, shelf life, and patient compliance.

• Colorant Suppliers: Companies like Sensient Technologies supply colorants approved for pharmaceutical use, vital for the tablet's visual identification.

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Distribution and Logistics

The global distribution network for Daliresp involves multiple logistics providers specializing in cold chain and temperature-sensitive pharmaceuticals:

• DHL Healthcare & Life Sciences: Offers global logistics solutions with validated cold chain management, ensuring API and finished products reach markets without compromise.

• FedEx Pharmaceutical Services: Provides customized transportation options aligned with Good Distribution Practice (GDP) standards.

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Regulatory and Quality Considerations

Procuring from reliable and compliant suppliers is critical:

• GMP Certification: Ensures suppliers meet stringent manufacturing standards mandated by regulatory bodies like the FDA and EMA.

• Environmental, Social, and Governance (ESG) Standards: Increasing importance influences supplier selection, prioritizing sustainability and ethical manufacturing practices.

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Market Dynamics and Supply Chain Risks

The supply chain for Daliresp is complex, with risks such as geopolitical disruptions, raw material shortages, and manufacturing bottlenecks. AstraZeneca's strategic partnerships with multiple suppliers across regions mitigate these risks, maintaining supply continuity.

Emerging global capacities in India and China for chemical intermediates and APIs have introduced more options but require stringent regulatory vetting.

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Key Takeaways

• The supply chain for Daliresp involves multiple tiers, from chemical raw materials to formulation and distribution, highlighting the importance of supplier reliability.

• Major chemical suppliers like BASF and Sigma-Aldrich supply critical intermediates for API synthesis, emphasizing the need for quality and regulatory compliance.

• Contract manufacturing organizations such as Idorsia and Dr. Reddy's play pivotal roles in scalable API manufacturing, supporting the drug's global distribution.

• Logistics partners ensure temperature-controlled global distribution, vital for maintaining drug integrity.

• Strategic supplier diversification and strict adherence to GMP standards are essential to mitigate risks associated with API and drug supply.

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FAQs

1. Who are the primary API suppliers for Daliresp?
The primary API manufacturing capacities are held by AstraZeneca in-house, with additional supply from CMOs like Idorsia and Dr. Reddy’s Laboratories, ensuring global demand is met with high quality standards.

2. What role do chemical intermediates play in Daliresp production?
They serve as foundational building blocks in the synthesis of roflumilast, requiring high purity and chemical stability, supplied by companies such as BASF and Sigma-Aldrich.

3. How does AstraZeneca ensure the quality of the raw materials and API?
Through rigorous supplier qualification processes, requiring GMP certification, batch validation, and compliance with international quality standards.

4. Are there regional differences in Daliresp’s supply chain?
Yes. While Europe and North America primarily rely on AstraZeneca’s manufacturing, Asia (notably India and China) supplies intermediates and APIs via CMOs, offering cost-effective options.

5. How do logistics providers contribute to the Daliresp supply chain?
They manage the timely, temperature-sensitive shipment of raw materials, APIs, and finished products globally, minimizing risks of spoilage or delays.

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References

1. BASF SE. (2023). Pharmaceutical Intermediates.
2. Sigma-Aldrich. (2023). Chemical Building Blocks for Pharmaceutical Synthesis.
3. Toronto Research Chemicals. (2023). Specialty Chemical Intermediates.
4. Lanxess AG. (2023). Specialty Chemicals for API Manufacturing.
5. Idorsia Pharmaceuticals. (2023). API Manufacturing Capabilities.
6. Dr. Reddy's Laboratories. (2023). API and GMP Standards.
7. Jubilant HollisterStier. (2023). Contract Manufacturing for Active Ingredients.