Bulk Pharmaceutical API Sources for DARIFENACIN

Bulk Pharmaceutical API Sources for DARIFENACIN

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-302
Molport		MolPort-005-943-011
AKos Consulting & Solutions		AKOS015907962
MedChemexpress MCE		HY-A0033
AbaChemScene		CS-1168
AvaChem Scientific		133099-04-4
AvaChem Scientific		2241B

Bulk Active Pharmaceutical Ingredient (API) Sources for Darifenacin: A Comprehensive Overview

Last updated: July 28, 2025

Introduction

Darifenacin, a selective M3 muscarinic receptor antagonist, is primarily indicated for the treatment of overactive bladder (OAB). As a vital component in pharmaceutical formulations, the procurement of high-quality bulk Active Pharmaceutical Ingredients (APIs) is critical. Reliable API sourcing influences drug efficacy, regulatory compliance, and production costs. This report delineates the current landscape of API suppliers, quality standards, regulatory considerations, and strategic sourcing insights pertinent to darifenacin.

Overview of Darifenacin API

Darifenacin (chemical name: (±)-N-[(1R)-1-[(2RS)-2-hydroxy-2-phenylethyl]-1-(3-methylphenyl)-ethyl]-3,4-dihydro-1H-isoquinoline-2-carboxamide) is synthesized through multi-step chemical processes, requiring strict control over purity, residual solvents, and by-products. The API demand correlates with OAB prevalence, with manufacturing primarily concentrated among select pharmaceutical excipients and API producers.

Major API Manufacturers for Darifenacin

1. Major International API Producers

a. Jiangsu Hengrui Medicine Co., Ltd. (China)

Hengrui is renowned for its extensive portfolio of central nervous system (CNS) and urology APIs. The company has established GMP-compliant manufacturing facilities capable of producing darifenacin at commercial scales, targeting both domestic and international markets. Their quality standards adhere to ISO and CFR requirements, with certifications from regulatory bodies such as the SFDA and EMA.

b. Zhejiang Jiangshan Pharmaceutical Co., Ltd. (China)

Specializing in specialty APIs, Jiangshan Pharmaceutical has developed darifenacin synthesis routes targeting global markets. Their facilities maintain ISO 9001 and cGMP accreditation, confirming adherence to stringent quality controls necessary for APIs intended for prescription medications.

c. Teva Pharmaceuticals (Israel)

As one of the world's leading generic API manufacturers, Teva produces a broad spectrum of pharmaceuticals, including APIs for urology treatments. Although specific sourcing details for darifenacin are confidential, Teva's global manufacturing footprint suggests potential supply options, especially for compound intermediates.

d. Dr. Reddy's Laboratories (India)

Dr. Reddy's emphasizes API manufacturing for CNS and urological indications. They possess facilities meeting USFDA and EDQM standards, capable of producing standardized darifenacin APIs following strict quality specifications, making them reliable suppliers for global markets.

2. Regional API Suppliers

a. Indian API Manufacturers

India remains a dominant hub for generic APIs, with companies such as Natco Pharma and Aurobindo Pharma offering APIs for urological indications. While darifenacin-specific API availability varies, these companies possess the technical capability to synthesize and supply darifenacin upon customer specification, with a focus on cost efficiency and compliance.

b. European API Suppliers

European manufacturers such as HIPRA and Recipharm are known for high-quality APIs with advanced R&D and quality systems aligned to EMA standards. While specific darifenacin API production information is limited, their extensive expertise in complex APIs makes them potential sources.

3. Contract Manufacturing Organizations (CMOs)

Several CMOs globally offer custom synthesis of darifenacin for clinical trial and commercial use. Engaging with reputable CMOs provides flexibility in quantities and aligns with regulatory requirements, especially when establishing dual or multi-source strategies.

Regulatory and Quality Standards

AS APIs serve as critical raw materials, their quality impacts drug safety and efficacy. Leading suppliers maintain rigorous compliance with:

• US FDA Current Good Manufacturing Practice (cGMP) standards: Ensures consistent quality, purity, and potency.
• European Pharmacopoeia (Ph. Eur.) standards: Provides monographs and specifications for APIs.
• International Organization for Standardization (ISO): Enforces quality management systems.
• Additional certifications: COA (Certificate of Analysis), DMF (Drug Master File) availability, and batch documentation.

Potential buyers should verify suppliers’ certifications, batch consistency, and quality control measures before entering procurement agreements.

Supply Chain Considerations

a. Quality and Purity

Ensuring pharmaceutical-grade purity (>99%) and compliance with pharmacopoeial standards is non-negotiable. Suppliers should provide COAs detailing impurities, residual solvents, heavy metals, and degradation products.

b. Lead Times and MOQ

Establishing reliable lead times and minimum order quantities (MOQs) is vital for production planning. Larger suppliers typically offer shorter lead times but may require bulk orders, while smaller or regional manufacturers offer flexible sourcing options.

c. Regulatory Recognition and Documentation

Suppliers with established DMFs or equivalents accelerate regulatory filings and audits. Transparency in manufacturing processes and history of regulatory inspections enhance confidence.

d. Cost and Risk Management

Diversifying suppliers mitigates supply risks and price volatility. Recent trends favor dual-source strategies, especially from suppliers with proven regulatory track records.

Emerging Trends and Future Directions

a. Contract Manufacturing and Customized APIs

The trend towards outsourced custom synthesis enables pharmaceutical companies to scale API production rapidly, optimize costs, and meet regulatory demands efficiently. Increasing use of biocatalysis and green chemistry methods may influence darifenacin synthesis in future manufacturing.

b. Patent and Market Dynamics

As patent protections for darifenacin mature, generic manufacturers expand production, driving competition and potentially reducing costs. However, regulatory barriers remain critical, demanding high-quality, compliant APIs.

c. Supply Chain Resilience Post-Pandemic

COVID-19 underscored vulnerabilities in API supply chains. Companies now prioritize geographic diversification, strategic stockpiling, and partnerships with multiple suppliers to ensure uninterrupted access.

Conclusion

Securing a reliable source of high-quality darifenacin API requires careful consideration of manufacturing quality standards, regulatory compliance, and supply chain stability. Leading Chinese and Indian manufacturers, complemented by global CMOs, offer diverse options. Engaging with suppliers possessing robust certifications, transparent processes, and scalable capacities is crucial for minimizing regulatory risks and ensuring consistent drug supply.

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Key Takeaways

• Trusted API suppliers include Jiangsu Hengrui, Zhejiang Jiangshan, Teva, Dr. Reddy’s, and top Indian and European manufacturers.
• Ensuring supplier GMP compliance and pharmacopoeial adherence is essential for regulatory approval.
• Diversification of supply—multi-sourcing—reduces risks associated with geopolitical and supply chain disruptions.
• Engage with manufacturers providing comprehensive documentation, such as COAs and DMFs, to streamline regulatory filing processes.
• Staying informed of industry trends like green chemistry, contract manufacturing, and supply chain resilience enhances sourcing strategies.

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FAQs

Q1: Is darifenacin API readily available from multiple global suppliers?
A1: While some major manufacturers produce darifenacin API, availability varies. Larger Chinese and Indian producers with GMP certification are potential sources, often providing flexible supply options.

Q2: What are the key quality parameters to consider when sourcing darifenacin API?
A2: Ensure >99% purity, compliance with pharmacopoeial standards, low residual solvents, absence of harmful impurities, and consistent batch-to-batch quality verified through detailed Certificates of Analysis.

Q3: How does regulatory compliance influence API sourcing decisions?
A3: Regulatory compliance ensures that APIs meet safety and efficacy standards, facilitating faster registration and reducing risk of non-compliance penalties. Suppliers with validated manufacturing processes and documented regulatory histories are preferred.

Q4: What role do Contract Manufacturing Organizations play in sourcing darifenacin?
A4: CMOs offer custom synthesis tailored to specific quality and quantity needs, providing manufacturing flexibility and scalability, especially for clinical trial supplies and early commercialization.

Q5: How has the COVID-19 pandemic impacted API supply chains for darifenacin?
A5: The pandemic exposed vulnerabilities, prompting companies to diversify suppliers, increase inventory buffers, and strengthen supply chain resilience, ensuring sustained access to APIs like darifenacin.

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References

1. Biopharma Research & Development. "API Manufacturing Standards." PharmaTech News, 2022.
2. USFDA. "Guidance for Industry—API Quality Assurance." 2021.
3. European Pharmacopoeia. "Standard Monographs for APIs." 2022.
4. MarketLine. "Global API Market Analysis." 2023.
5. Industry Reports. "Third-Party API Manufacturing Trends." 2022.