Bulk Pharmaceutical API Sources for DARIFENACIN HYDROBROMIDE

Bulk Pharmaceutical API Sources for DARIFENACIN HYDROBROMIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-846-139
Hangzhou APIChem Technology		AC-1894
Amadis Chemical		A806554
AKos Consulting & Solutions		AKOS015969311

Bulk Active Pharmaceutical Ingredient (API) Sources for Darifenacin Hydrobromide

Last updated: July 28, 2025

Introduction

Darifenacin hydrobromide is a prominent anticholinergic agent primarily employed for treating overactive bladder symptoms, including urinary frequency, urgency, and incontinence. Marketed under trade names such as Enablex, darifenacin selectively antagonizes M3 muscarinic receptors, effectively reducing bladder muscle contractions. As a critical component in pharmaceutical manufacturing, sourcing high-quality bulk API is essential for pharmaceutical companies aiming to ensure product efficacy, safety, and regulatory compliance.

This article provides an in-depth analysis of reliable sources for bulk darifenacin hydrobromide. It covers key factors influencing sourcing decisions, evaluates global suppliers' profiles, and presents best practices for procurement strategies in this niche API market.

Market Landscape and API Market Overview

The global active pharmaceutical ingredient (API) market is characterized by a mixture of major multinational manufacturers and a growing number of regional suppliers. The demand for specialized APIs like darifenacin hydrobromide hinges on factors such as patent status, manufacturing complexity, and regulatory approval.

Darifenacin, first approved by regulatory agencies such as the U.S. Food and Drug Administration (FDA), is a niche API with limited but steady demand. Its synthesis involves complex chiral chemistry, underscoring the importance of sourcing from established high-quality producers capable of meeting stringent pharmaceutical standards (e.g., cGMP compliance).

Criteria for Selecting API Suppliers

When sourcing darifenacin hydrobromide, manufacturers consider several critical parameters:

• Regulatory Compliance: Suppliers must meet cGMP standards and hold requisite certifications such as ISO, DMF (Drug Master File), and CEP (Certificate of Suitability).

• Product Quality: High purity levels (typically ≥ 99%), consistent quality, and comprehensive analytical data are non-negotiable.

• Manufacturing Capacity and Reliability: Suppliers with sufficient capacity to meet supply timelines and proven delivery records are preferable.

• Pricing and Cost Effectiveness: Competitive pricing balanced with quality considerations can influence supplier selection.

• Supply Chain Security: Proven logistics capabilities and robust supply chain management reduce risk of disruptions.

Major API Suppliers for Darifenacin Hydrobromide

1. Endo Laboratories (India)

Endo Laboratories is a reputed Indian pharmaceutical ingredient manufacturer with a diverse portfolio of APIs, including darifenacin hydrobromide. Underpinned by ISO-certified manufacturing facilities and adherence to cGMP standards, the company supplies APIs to multinational pharmaceutical firms.

• Capabilities: Small to medium batch production, comprehensive analytical documentation, and flexible order quantities.
• Certifications: ISO 9001, DMF filings in the U.S.

2. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)

Hisun Pharmaceuticals is among China's leading pharmaceutical exporters, offering high-quality APIs with competitive pricing. Their facilities are cGMP-compliant and equipped with advanced synthesis and purification technologies.

• Product Portfolio: A broad spectrum of CNS and urology APIs, including darifenacin.
• Regulatory Status: DMF filings and product approvals in multiple markets.

3. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)

Huahai is a significant manufacturer known for complex generics and APIs. Their expertise in chiral molecule synthesis positions them as a potential source for darifenacin hydrobromide.

• Quality Assurance: Strict quality control per international standards.
• Supply Capabilities: Sufficient capacity to support global demand.

4. Pharmaceutica Chemicals Ltd. (India)

Specialized in niche APIs, Pharmaceutica Chemicals supplies darifenacin hydrobromide for research and commercial use.

• Advantages: Flexibility in custom synthesis and rapid turnaround times.
• Certifications: C-GMP, ISO 9001.

5. Global API Marketplaces and Brokers

Platforms such as ChemExpress, Yumpu, Alibaba Pharma Suppliers, and Pharmacopia connect end-users with verified API manufacturers and brokers, enhancing access to multiple sources of darifenacin hydrobromide. While these platforms facilitate procurement, due diligence regarding supplier legitimacy and quality certifications remains imperative.

Regional Dynamics and Market Trends

The API sourcing landscape is heavily influenced by regional manufacturing strengths:

• India: Renowned for a vast number of API producers with a balance of quality and cost efficiency. The Indian government’s focus on cGMP standards increases confidence in sourcing from this region.

• China: Dominant in API manufacturing, especially for complex molecules like darifenacin. Chinese suppliers benefit from scale and technological advancements but may face variability in regulatory acceptance globally.

• Europe and North America: With stringent quality demands, these regions house fewer API producers but often serve as sources for high-end, fully validated APIs with detailed documentation.

Best Practices in API Sourcing for Darifenacin Hydrobromide

1. Due Diligence: Verify supplier certifications, review audit reports, and assess quality control protocols.

2. Sample Testing: Obtain and analyze samples for purity, potency, and impurity profile before large-scale procurement.

3. Regulatory Validation: Ensure that suppliers can provide necessary documentation (DMF, CEP) compatible with target markets' regulatory frameworks.

4. Long-term Partnerships: Establish strategic relationships with reliable manufacturers to secure supply continuity and favorable pricing.

5. Supply Chain Risk Management: Diversify sources to mitigate geopolitical risks, supply disruptions, and regulatory uncertainties.

Regulatory Considerations

Regulatory agencies such as FDA, EMA, and PMDA rigorously evaluate APIs for pharmaceutical manufacturing. Suppliers with validated manufacturing processes, existing regulatory filings, and proven compliance are preferred. Companies must also ensure raw material sourcing, synthesis routes, and impurity profiles meet these agency standards.

Future Outlook

As the demand for overactive bladder therapeutics persists and the patent landscape evolves, sourcing strategies for darifenacin hydrobromide will likely emphasize innovation in synthesis pathways, cost reduction, and supply chain resilience. Increased collaborative efforts between manufacturers and researchers may lead to enhanced API quality and production efficiencies.

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Key Takeaways

• The global market for darifenacin hydrobromide API is centered around high-quality suppliers from India and China, with European and North American sources primarily serving high-end regulatory markets.
• Selection criteria must prioritize regulatory compliance, product purity, manufacturing reliability, and supply chain security.
• Established manufacturers such as Endo Laboratories, Zhejiang Hisun, and Zhejiang Huahai are prominent sources, supported by their certifications and capacity.
• Due diligence, sample testing, and certification verification are essential steps toward secure procurement.
• Strategic partnerships with reputable API suppliers can optimize quality, pricing, and supply continuity.

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FAQs

1. What are the main factors influencing the quality of darifenacin hydrobromide APIs?
Product purity, manufacturing process validation, impurity profile, and compliance with cGMP standards primarily determine API quality.

2. Are there any regulatory hurdles in sourcing APIs from Chinese manufacturers?
Yes. While many Chinese API producers are compliant with international standards, companies must verify filings such as DMFs, ensure product traceability, and conduct rigorous quality audits to meet global regulatory requirements.

3. How can companies assess the reliability of API suppliers?
By reviewing certification documents, conducting on-site audits, requesting API test results, and evaluating supplier track records in delivery and quality consistency.

4. Is it advisable to use API brokers for sourcing darifenacin hydrobromide?
While brokers can facilitate access to multiple suppliers and competitive pricing, thorough due diligence is vital to ensure legitimacy, quality, and regulatory compliance.

5. What are future trends affecting API sourcing for niche compounds like darifenacin?
Emerging trends include increased adoption of continuous manufacturing, digitization of supply chains, and stricter regulatory scrutiny, all emphasizing transparency, data integrity, and supplier qualification.

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References

[1] Market Research Future. "Active Pharmaceutical Ingredients Market Analysis." 2022.
[2] U.S. Food and Drug Administration. "Drug Master Files (DMF)." 2023.
[3] European Medicines Agency. "Certificate of Suitability (CEP) Procedures." 2022.
[4] GlobalTradeInfo. "API Market Trends and Regional Drivers." 2022.
[5] PharmaIQ. "Sourcing Strategies for Controlled-Substance APIs." 2022.