Bulk Pharmaceutical API Sources for ENABLEX

Bulk Pharmaceutical API Sources for ENABLEX

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-846-139
Hangzhou APIChem Technology		AC-1894
Amadis Chemical		A806554
AKos Consulting & Solutions		AKOS015969311
MedChemexpress MCE		HY-A0012
AbaChemScene		CS-0380

Bulk Active Pharmaceutical Ingredient (API) Sources for Enablex (Darifenacin)

Last updated: July 30, 2025

Introduction

Enablex, the brand name for darifenacin, is a muscarinic receptor antagonist used predominantly to treat overactive bladder (OAB). As a critical component in pharmaceutical manufacturing, the quality, sourcing, and regulation of its active pharmaceutical ingredient (API) significantly influence manufacturing costs, product quality, and regulatory compliance. Understanding the global API supply landscape for darifenacin is vital for stakeholders across manufacturing, procurement, and regulatory domains.

Overview of Darifenacin API

Chemical Profile and Synthesis

Darifenacin is a selective M3 muscarinic receptor antagonist, chemically designated as N-(2-butynyl)-N′-cyclohexyl-2,3-dihydro-1H-byrano[3,2-e]pyrido[4,3-b]indole-1,4-dicarboxamide. Its complex chemical structure necessitates sophisticated synthesis routes. Manufacturing typically involves multi-step processes, including aromatic substitutions and heterocyclic ring closures, with strict control over stereochemistry and purity.

Regulatory Considerations

API manufacturers must adhere to Good Manufacturing Practice (GMP) standards, ensuring the API's safety, efficacy, and quality. Regulatory approval from agencies like the U.S. FDA, EMA, or other national agencies mandates comprehensive documentation and testing, influencing sourcing decisions.

Major API Suppliers for Darifenacin

The supply of darifenacin API is concentrated among a limited number of reputable manufacturers with proven compliance histories and advanced synthesis capabilities. The primary global suppliers include:

1. Sun Pharmaceutical Industries Ltd.

Sun Pharma, headquartered in India, is one of the leading API producers with extensive experience in producing complex molecules like darifenacin. The company offers GMP-compliant APIs and has a robust R&D backbone for process optimization. Their API manufacturing facilities in India have received multiple regulatory inspections without major findings, making them a preferred supplier.

2. Dr. Reddy’s Laboratories

Veteran in the global API market, Reddy’s offers high-quality APIs including darifenacin. The company maintains facilities compliant with international standards and provides reliable supply chains backed by advanced quality assurance systems. Dr. Reddy’s emphasizes sustainable manufacturing practices and adheres to stringent quality controls.

3. Zhejiang Hisoar Pharmaceutical Co., Ltd.

Located in China, Hisoar is expanding as a supplier of specialty APIs, including darifenacin. Their competitive pricing and capacity for large-volume production have increased their presence in the generics API market. They meet international GMP standards, though potential clients often conduct rigorous audits before establishing supply agreements.

4. Aurobindo Pharma

Another Indian API manufacturer, Aurobindo offers a broad portfolio, including darifenacin. The company's facilities are GMP-certified, and its strategic focus on high-potency APIs ensures compliance with regulatory expectations. Their extensive export network facilitates global distribution.

5. Other Notable Suppliers

Additional companies, such as Mylan (now part of Viatris), and Teva Pharmaceuticals, have demonstrated capacities for API production, although their direct involvement in darifenacin production is less prominent. Many global generics companies source APIs from contract manufacturing organizations (CMOs) to fill specific demand volumes.

Global API Sourcing Dynamics

The sourcing landscape for darifenacin API reflects broader trends impacting pharmaceutical supply chains:

• Regional Concentration: Indian and Chinese manufacturers dominate due to cost competitiveness, manufacturing scale, and technological capabilities.
• Regulatory Stringency: Increasingly rigorous GMP standards and regional export regulations necessitate thorough supplier vetting.
• Supply Chain Resilience: COVID-19 pandemic underscored the importance of diversified sourcing to mitigate risks associated with supply disruptions.
• Patent and Market Exclusivity: As patents expire or face legal challenges, generic API manufacturers capitalize on the opportunity, expanding the market supply.

Supply Chain Considerations

Quality Assurance and Regulatory Compliance

Securing APIs from GMP-certified manufacturers mitigates regulatory risks and ensures product integrity. International audits, Master Cell Bank (MCB) documentation, and stability data are standard prerequisites for establishing supply relationships.

Price Factors

Pricing varies based on manufacturing complexity, country of origin, batch size, and supply chain logistics. Indian manufacturers generally offer competitive prices, while Chinese suppliers may provide cost advantages but face scrutiny regarding quality assurance frameworks.

Lead Times and Capacity

Lead times for API procurement depend on manufacturing capacity, order volume, and regulatory clearance. Establishing long-term contracts with reliable suppliers ensures supply stability.

Future Outlook

Emerging biosimilar and generic markets will likely expand API sourcing options. Technological advancements in synthetic chemistry and process development are expected to enhance yield efficiencies and reduce costs. Additionally, regulatory initiatives such as the US Drug Supply Chain Security Act (DSCSA) incentivize supply chain transparency.

Key Factors for Sourcing Strategy

• Regulatory Track Record: Prioritize suppliers with proven GMP compliance and regulatory track record.
• Manufacturing Capacity: Verify capacity to meet demand fluctuations.
• Quality Systems: Confirm adherence to quality standards, including validated processes and stability testing.
• Pricing and Lead Time: Balance cost considerations with reliability and supply continuity.
• Supply Chain Security: Diversify sources to prevent reliance on a single supplier, mitigating geopolitical and logistical risks.

Key Takeaways

• The primary sources for darifenacin API are Indian and Chinese manufacturers such as Sun Pharma, Dr. Reddy’s, Zhejiang Hisoar, and Aurobindo.
• Regulatory compliance and GMP certification are non-negotiable criteria when selecting API suppliers.
• Geographic diversification of API sources enhances supply chain resilience amid geopolitical and pandemic-related disruptions.
• Technological improvements and regulatory changes will continue to shape the API sourcing landscape.
• Establishing long-term relationships with multiple qualified suppliers ensures stable, compliant, and cost-effective APIs.

FAQs

1. What are the main factors influencing the choice of API suppliers for Enablex?
Regulatory compliance, manufacturing capacity, quality assurance systems, cost, lead times, and the supplier’s reputation are pivotal factors.

2. Are there regional preferences for sourcing darifenacin API?
Indian and Chinese manufacturers dominate due to cost and capacity advantages, though regulatory frameworks influence supplier selection regionally.

3. How does regulatory compliance impact API sourcing for darifenacin?
Regulatory compliance ensures API quality, facilitates market approval, reduces audit and recall risks, and ensures ongoing supply under GMP standards.

4. Is it possible to source darifenacin API from multiple suppliers?
Yes; diversifying API sources enhances supply chain stability and mitigates risks associated with political, logistical, or quality issues.

5. What trends are influencing future API sourcing for overactive bladder medications like Enablex?
Technological advancements, stricter regulations, increased focus on supply chain resilience, and market expansion are shaping future sourcing strategies.

---

References

[1] European Medicines Agency. Darifenacin Summary of Product Characteristics. 2022.
[2] U.S. Food and Drug Administration. API GMP Inspection Guide. 2021.
[3] MarketLine. Pharmaceutical API Market Analysis. 2023.
[4] IQVIA. Global API Manufacturing & Supply Chain Report. 2022.
[5] Company disclosures and public filings of Sun Pharma, Dr. Reddy’s, and other manufacturers.