Bulk Pharmaceutical API Sources for roflumilast

Bulk Pharmaceutical API Sources for roflumilast

Vendor	Vendor Homepage	Vendor Sku	API Url
AKos Consulting & Solutions		AKOS005146309
Amadis Chemical		A24672
BioChemPartner		BCP0726000146
MedChemexpress MCE		HY-15455
AbaChemScene		CS-0963
Molport		MolPort-006-069-128
Finetech Industry Limited		FT-0660846

Bulk Active Pharmaceutical Ingredient (API) Sources for Roflumilast

Last updated: July 30, 2025

Introduction

Roflumilast is a selective phosphodiesterase-4 (PDE4) inhibitor used primarily in the management of severe chronic obstructive pulmonary disease (COPD). Since its approval by regulatory agencies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency), the demand for high-quality bulk API has surged among pharmaceutical manufacturers. Supply chain stability, quality assurance, and regulatory compliance are critical components in sourcing Roflumilast API from global suppliers.

This report offers a comprehensive overview of primary sources for bulk Roflumilast API, addressing key manufacturers, geographic regions, quality considerations, and regulatory factors impacting sourcing decisions.

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Global API Manufacturers for Roflumilast

1. Contract Manufacturing Organizations (CMOs)

Several CMOs specialize in synthesizing and supplying Roflumilast API at pharmaceutical scale. These organizations typically operate under strict regulatory standards such as cGMP (current Good Manufacturing Practice) to ensure API quality and compliance with international standards.

Leading CMOs include:

• Jiangsu Hengrui Medicine Co., Ltd. (China):
  A prominent Chinese pharmaceutical company with extensive experience in PDE4 inhibitors, Hengrui supplies Roflumilast API to global clients. They adhere to international quality standards, making them a reliable source.

• BASF SE (Germany):
  A global chemical leader with capabilities in active pharmaceutical ingredient synthesis, BASF develops and supplies APIs through partnerships or direct sales, emphasizing high purity and GMP compliance.

• Piramal Enterprises Ltd. (India):
  An established Indian pharma manufacturer that offers a range of APIs, including Roflumilast, with strict quality controls aligned with international regulatory requirements.

• Shandong Xinhua Pharmaceutical Co., Ltd. (China):
  Focused on generic APIs, they have/have developed Roflumilast APIs for regional and export markets.

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2. Large-Scale API Producers and Suppliers

Key regional sources include:

• Europe:
  European pharmaceutical giants such as Symeres (Netherlands) and Evonik Industries (Germany) provide high-purity APIs, including Roflumilast, leveraging advanced synthesis and purification technologies.

• North America:
  Although fewer companies specialize in Roflumilast API specifically, some North American firms are engaged in R&D and production under licensing agreements, such as AbbVie, which initially developed Roflumilast.

• India:
  The Indian pharmaceutical industry hosts multiple API manufacturers specializing in generic and novel APIs. Companies such as Divis Labs and Hetero Labs are potential API sources, with capabilities for large-scale synthesis and global distribution.

• China:
  The Chinese API manufacturing sector has expanded significantly, with several manufacturers capable of supplying Roflumilast API at competitive prices, subject to quality verification.

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Quality and Regulatory Considerations

When sourcing Roflumilast API, verifying qualification status, manufacturing standards, and documentation is paramount.

GMP Certification

Suppliers must adhere to cGMP standards, ensuring consistent quality, purity, and batch-to-batch reproducibility. Regulatory agencies inspect and certify manufacturing facilities accordingly.

Analytical Data and Purity

High purity (>99%) Roflumilast API is generally required for pharmaceutical applications. Suppliers should provide comprehensive analytical data, including HPLC, residual solvents, heavy metals, and stability profiles.

Regulatory Approvals

APIs sourced from suppliers with approvals or certifications from agencies like the FDA, EMA, PMDA (Japan), or TGA (Australia), facilitate faster registration and reduce compliance risks.

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Market Trends and Supply Chain Dynamics

The global API market for Roflumilast is influenced by factors such as patent status, generic market expansion, and manufacturing capacity. Following patent expiry in certain regions, a proliferation of generic providers has emerged, increasing supply options and competitive pricing.

Supply chain disruptions, exemplified during the COVID-19 pandemic, underscored the importance of diversifying sources and establishing reliable vendor relationships. Manufacturers are increasingly seeking dual sources or geographically dispersed suppliers to mitigate risks.

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Emerging Supply Sources and Innovations

Advancements in chemical synthesis and contract manufacturing are expanding potential supply pools. Some suppliers are investing in green synthesis methods to improve environmental sustainability while maintaining product quality.

Moreover, some firms are developing continuous manufacturing processes, enabling scalable, efficient production of Roflumilast API with reduced lead times.

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Key Considerations for Sourcing

• Confirm supplier GMP certifications and quality compliance.
• Evaluate analytical reports and batch records.
• Negotiate supply agreements that specify purity standards, delivery timelines, and regulatory documentation.
• Consider the geopolitical stability and country-specific regulatory environment.
• Conduct site audits or third-party assessments when possible.
• Establish contingency plans to mitigate potential supply chain disruptions.

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Conclusion

Sourcing bulk Roflumilast API involves navigating a complex landscape of regional manufacturers, regulatory standards, and quality assurance protocols. Established suppliers in Europe, North America, India, and China provide a broad spectrum of options, with capabilities ranging from high-purity APIs to cost-effective generics. Due diligence, including verification of GMP compliance and analytical quality, remains indispensable in establishing reliable and compliant supply chains.

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Key Takeaways

• Diverse Supplier Base: Major pharmaceutical manufacturing regions—Europe, North America, India, and China—offer multiple API sources for Roflumilast, increasing supply chain resilience.
• Quality Assurance: GMP certification, analytical validation, and regulatory approvals are critical parameters for evaluating API suppliers.
• Market Dynamics: Patent expirations and increasing generic competition are leading to more affordable and accessible Roflumilast APIs.
• Supply Chain Risks: Concentration risks and geopolitical factors necessitate diversified sourcing strategies and contingency planning.
• Innovation and Sustainability: Emerging green synthesis methods and continuous manufacturing are shaping future API supply capabilities.

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FAQs

1. Are there major differences in API quality among regional suppliers?
Yes, quality varies depending on the manufacturer’s adherence to GMP standards, analytical controls, and regulatory certifications. Suppliers with established certifications and third-party audits generally provide higher assurance of consistency and purity.

2. How does patent status influence API sourcing options for Roflumilast?
Patent expiries in certain regions have facilitated the entry of generic manufacturers, broadening sourcing options and reducing costs. However, proprietary formulations or exclusivity periods still affect availability in some markets.

3. What regulatory challenges are associated with international API sourcing?
Regulatory compliance demands rigorous documentation, validation, and certification. Importing APIs from jurisdictions with differing standards necessitates thorough verification and often includes regulatory delays or registration hurdles.

4. Can I negotiate customization or specific specifications with API suppliers?
Yes. Leading suppliers often accommodate specific purity levels, particle sizes, or packaging requirements, provided quality parameters align with regulatory standards and commercial considerations.

5. What are the risks of relying on a single API supplier?
Single sourcing exposes manufacturers to supply disruptions, quality inconsistencies, and regulatory complications. Diversifying suppliers and establishing backup arrangements mitigate these risks.

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Sources

[1] U.S. Food and Drug Administration (FDA). "Approved Drugs: Roflumilast." https://www.fda.gov
[2] European Medicines Agency (EMA). "Roflumilast Summary of Product Characteristics." https://www.ema.europa.eu
[3] Industry reports on API manufacturing and supply chain dynamics published in 2022-2023.