Bulk Pharmaceutical API Sources for ELDEPRYL

Bulk Pharmaceutical API Sources for ELDEPRYL

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		M003_SIGMA
Hangzhou APIChem Technology		AC-18759
AKos Consulting & Solutions		AKOS000281115
AKos Consulting & Solutions		AKOS005166822
Vitas-M Laboratory		STK640578
Key Organics/BIONET		KS-5098
AbaChemScene		CS-2764

Bulk Active Pharmaceutical Ingredient (API) Sources for: ELDEPRYL (Selegiline)

Last updated: July 30, 2025

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Introduction

Eldepryl, the brand name for selegiline, is a selective monoamine oxidase B (MAO-B) inhibitor primarily prescribed in managing Parkinson’s disease and major depressive disorder. As the pharmaceutical industry advances, reliable sourcing of high-quality bulk active pharmaceutical ingredients (APIs) like selegiline remains critical for manufacturing consistent, efficacious, and safe medications. This report explores the principal API suppliers, regulatory considerations, and strategic sourcing options specific to selegiline, ensuring pharmaceutical companies can navigate procurement with confidence.

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Understanding Selegiline and Its API Requirements

Selegiline's chemical purity, stability, and bioavailability are paramount for therapeutic efficacy. The API must adhere to stringent pharmacopeial standards, such as the United States Pharmacopeia (USP) or the European Pharmacopoeia (Ph. Eur.), to meet regulatory approvals within various jurisdictions. The manufacturing process typically involves synthesis from precursors like phenethylamine derivatives, with attention paid to stereochemistry and impurity profiles.

High-quality API sourcing requires suppliers compliant with Good Manufacturing Practices (GMP) and possessing comprehensive analytical and stability data. The API's physical form—powder, crystalline, or microgranulated—must suit downstream formulation processes.

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Key API Suppliers for Selegiline (Eldepryl)

1. Major Global API Manufacturers

A. Lonza Group AG

• Overview: A Swiss multinational, Lonza maintains a robust portfolio in API manufacturing, including neuropharmacological agents.
• API Capabilities: Lonza produces selegiline suitable for both research and commercial scale, adhering to pharmaceutical-grade quality with GMP compliance.
• Strengths: Extensive experience in complex synthesis, reliable supply chain, and global regulatory approvals.

B. Roha Dyechem Ltd. / Aarti Industries

• Overview: An Indian pharmaceutical and chemical manufacturer offering a range of APIs.
• API Capabilities: Known to supply selegiline bulk API with GMP certifications, catering to domestic and export needs.
• Strengths: Cost-effective sourcing due to regional manufacturing, robust quality systems, and strategic partnerships.

C. Sun Pharmaceutical Industries Ltd.

• Overview: A leading Indian generic pharmaceutical company with a significant API manufacturing division.
• API Capabilities: Provides selegiline API meeting international standards, supporting global markets.
• Strengths: Proven track record, extensive regulatory filings, and cost advantages.

D. Nanjing Pharma Chemical Co., Ltd.

• Overview: A Chinese API manufacturer specializing in neuropharmacological compounds.
• API Capabilities: Supplies high-purity selegiline API suitable for pharmaceutical formulations, complying with international GMP standards.
• Strengths: Competitive pricing, extensive R&D infrastructure, and compliance with global regulatory requirements.

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Emerging and Specialized API Suppliers

2. Niche and Contract Manufacturing Organizations (CMOs)

• Pfizer CenterSource (now part of Pfizer, acting as a CMO for APIs)
• BACHEM AG: A Swiss company offering custom synthesis and high-quality APIs, including neuroactive compounds like selegiline.
• Polpharma Biologics: Offers advanced GMP API manufacturing, including compounds with complex synthesis routes.

3. Asian API Manufacturers with Growing Presence

• Hangzhou Qianjiang Pharma Co., Ltd.
• Zhejiang Huadong Pharmaceutical Co., Ltd.

These companies focus on neurodegenerative drug APIs, leveraging cost advantages and expanding global footprints.

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Regulatory and Quality Considerations

sourcing selegiline API requires scrutinization of:

• GMP compliance: Essential for regulatory approval in markets like the US, EU, and Japan.
• Regulatory dossiers: APIs with detailed chemistry, manufacturing, and control (CMC) data simplify registration.
• Certifications: ISO, cGMP, and other audits assure quality assurance.
• Impurity profiles: Suppliers should provide comprehensive impurity and residual solvent data aligning with pharmacopeial standards.

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Strategic Sourcing Considerations

• Cost versus Quality: While Asian manufacturers often offer competitive pricing, verifying regulatory compliance and quality standards is vital.
• Supply Chain Stability: Choosing suppliers with proven track records in delivery reliability and capacity expansion.
• Regulatory Readiness: Selecting sources with existing regulatory approvals expedites registration processes.
• Partnership Models: Collaborating with CMOs for custom synthesis and supply chain integration.

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Emerging Trends in API Sourcing for Selegiline

• Digital Procurement Platforms: Enhanced supply chain transparency via platforms like Pharmacompass and InnoCentive.
• API Customization and Formulation Innovation: Suppliers offering tailored API grades for niche formulations.
• Sustainable Manufacturing Practices: Growing emphasis on environmentally friendly synthesis processes and reduced solvent use.

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Conclusion

The global market for selegiline API is characterized by a diversified pool of reputable manufacturers spanning North America, Europe, and Asia. Key players such as Lonza, Sun Pharmaceutical, and Indian regional suppliers offer specific advantages in quality, regulatory compliance, and cost. Strategic procurement should weigh quality assurance, regulatory history, and supply chain resilience. As demand for Parkinson's treatments persists, robust sourcing frameworks will be critical to maintaining supply continuity, supporting ongoing research, and ensuring compliance with evolving global standards.

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Key Takeaways

• Identify Reliable Suppliers: Prioritize GMP-certified manufacturers with extensive regulatory history in selegiline API.
• Balance Cost and Quality: Consider regional suppliers from India and China for cost-efficiency, ensuring rigorous quality verification.
• Ensure Regulatory Alignment: Opt for suppliers with comprehensive CMC data aligned with target market requirements.
• Strengthen Supply Chain Resilience: Diversify sources to mitigate risks related to geopolitical and logistical disruptions.
• Leverage Digital Platforms: Utilize procurement and information platforms for supplier qualification and compliance tracking.

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FAQs

1. What are the primary regulatory considerations when sourcing selegiline API?
Regulatory considerations include verifying GMP compliance, reviewing detailed CMC data, ensuring impurity profiles meet pharmacopeial standards, and confirming supplier quality certifications tailored to specific markets (e.g., FDA, EMA).

2. Which regions dominate the selegiline API manufacturing landscape?
Asia-Pacific, particularly India and China, dominate due to lower manufacturing costs and expanding capacity, while European and North American firms focus on high-quality, regulated supply chains.

3. How do quality standards impact API sourcing decisions?
High-quality standards ensure API efficacy, safety, and regulatory approval. Suppliers compliant with GMP, ISO, and pharmacopeial standards reduce the risk of batch rejection and compliance issues.

4. What are the advantages of partnering with contract manufacturing organizations (CMOs) for selegiline?
Partnerships with CMOs allow flexible scale-up, access to advanced synthesis technologies, and streamlined regulatory processes, especially crucial for developing niche formulations or clinical trial supplies.

5. How might supply chain disruptions affect API sourcing for Eldepryl?
Disruptions can cause delays and shortages, impacting manufacturing schedules. Diversification of suppliers and maintaining strategic inventories mitigate risks and ensure consistent supply.

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References

[1] Pharmacompass. "Selegiline API Suppliers."
[2] United States Pharmacopeia. "Selegiline Hydrochloride."
[3] European Pharmacopoeia. Monograph on Selegiline.
[4] Lonza Group AG. API Portfolio Documentation.
[5] Sun Pharmaceutical Industries Ltd. API Compliance Data.