Bulk Pharmaceutical API Sources for URISPAS

Bulk Pharmaceutical API Sources for URISPAS

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		F8304_SIGMA
TCI (Tokyo Chemical Industry)		F0717
Molport		MolPort-003-986-802
Hangzhou APIChem Technology		AC-1093
Amadis Chemical		A823554
Finetech Industry Limited		FT-0658191
Finetech Industry Limited		FT-0668549

Bulk Active Pharmaceutical Ingredient (API) Sources for URISPAS

Last updated: July 29, 2025

Introduction

URISPAS® (urispas) is a proprietary pharmaceutical product primarily known for its indications in the treatment of urinary disorders, notably overactive bladder and urinary incontinence. The formulation typically contains an active pharmaceutical ingredient (API) that exerts its therapeutic effects through specific mechanisms of action. Ensuring the quality, consistency, and reliable supply of this API is critical for pharmaceutical manufacturers seeking to produce URISPAS® formulations.

This article examines the primary sources for bulk APIs used in the production of URISPAS®, with a focus on key API suppliers, manufacturing considerations, and quality assurance protocols. It aims to inform stakeholders—including pharmaceutical companies, supply chain managers, and regulatory professionals—of the current landscape for sourcing APIs for URISPAS®.

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Understanding the API in URISPAS®: The Active Ingredient

URISPAS® contains Darifenacin, a selective M3 muscarinic receptor antagonist that reduces bladder muscle contractions, thus alleviating symptoms associated with overactive bladder. Darifenacin's pharmacodynamics and pharmacokinetics make it a suitable API candidate for oral formulations targeting urinary tract conditions.

Given the critical role of Darifenacin in URISPAS®, identifying its reliable bulk sources is paramount for seamless manufacturing and regulatory compliance.

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Global API Manufacturing Landscape for Darifenacin

1. Leading API Manufacturers

The API market for Darifenacin is characterized by a select group of European, North American, and Asian pharmaceutical API manufacturers. These suppliers have established compliance with Good Manufacturing Practices (GMP), possess robust quality systems, and maintain regulatory approvals from agencies like the FDA, EMA, or PMDA.

• AbbVie Inc.: Historically involved in the development and licensing of Darifenacin formulations, AbbVie also supplies APIs directly from its manufacturing facilities, primarily located in the United States and Europe. Their integrated supply chain assures high-quality standards.

• Aurobindo Pharma Ltd.: An India-based manufacturer with a rapidly expanding API portfolio, including Darifenacin. Aurobindo's facilities are GMP-certified, and the company frequently supplies APIs to the global market, including the United States, Europe, and emerging markets.

• Dr. Reddy’s Laboratories: Also based in India, Dr. Reddy’s offers Darifenacin APIs with compliance to international quality standards. Their strong R&D capabilities facilitate process optimization and scalable production.

• Mitsubishi Tanabe Pharma Corporation: A Japanese pharmaceutical company with a focus on niche therapies; they manufacture Darifenacin APIs for their proprietary products and may supply to licensed partners.

• Sun Pharmaceutical Industries Ltd.: Another prominent Indian manufacturer, Sun Pharma supplies Darifenacin APIs, emphasizing cost-effective, high-quality pharmaceutical ingredients that meet stringent GMP standards.

2. Contract Manufacturing Organizations (CMOs)

In addition to proprietary API producers, several CMOs are capable of synthesizing Darifenacin for clients seeking to outsource production:

• Lonza: Known for contract development and manufacturing, Lonza possesses extensive expertise in active pharmaceutical ingredients and can produce Darifenacin under client specifications.

• Catalent: Offers comprehensive CMO services, including the synthesis of niche APIs like Darifenacin, with validated processes adhering to global regulatory standards.

• BASF Pharma Solutions: Provides custom synthesis and bulk API manufacturing services, including complex molecules like Darifenacin, with a focus on scalable, compliant processes.

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Considerations in API Sourcing for URISPAS®

Quality and Regulatory Compliance

The most critical factor in selecting API suppliers is adherence to GMP standards and regulatory approvals. Suppliers must provide comprehensive documentation, including Certificates of Analysis (CoA), stability data, and compliance with pharmacopoeial standards (e.g., USP, EP, JP).

Supply Chain Reliability

Reliable supply chains ensure production continuity. Suppliers with diversified manufacturing sites and robust logistics capabilities mitigate risks related to geopolitical disruptions, raw material shortages, or manufacturing delays.

Cost and Contractual Terms

While cost considerations are essential for competitiveness, they should not override quality and compliance. Long-term relationships, flexible supply agreements, and volume discounts are typical negotiating priorities.

Process Analytical Technology (PAT) and Patent Status

Manufacturers employing advanced PAT methods can assure batch-to-batch consistency, a vital aspect for APIs like Darifenacin with complex synthesis pathways. Additionally, patent protections for Darifenacin APIs generally favor licensed suppliers, but off-patent or generic versions from approved manufacturers are widely available.

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Regional API Sources and Market Trends

North America and Europe

Major pharmaceutical companies and CMOs from North America and Europe dominate high-quality API production for Darifenacin. Regulatory oversight is stringent, ensuring top-tier standards.

Asia (India and China)

The Asian API manufacturing sector provides cost-competitive options with GMP compliance. Regulatory authorities like the Central Drugs Standard Control Organization (CDSCO) in India and the NMPA in China oversee quality, enabling their APIs to serve global markets.

Emerging Markets

Sourcing from emerging markets can offer economic advantages but requires rigorous quality validation and regulatory diligence.

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Regulatory Considerations in API Sourcing

Regulatory authorities emphasize validated manufacturing processes, comprehensive documentation, and traceability for APIs used in marketed products. When importing Darifenacin APIs, manufacturers must ensure supplier compliance with local regulations and international standards. Quality audits, supplier qualification, and batch validation are crucial steps in the sourcing process.

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2023 Trends and Innovations in API Supply

• Enhanced Quality Control: Suppliers incorporating real-time analytics and PAT methodologies improve batch consistency and reduce deviations.

• Sustainable Manufacturing: Increasing adoption of green chemistry principles reduces environmental footprint and aligns with regulatory expectations for responsible manufacturing.

• Supply Chain Diversification: Companies diversify API sources to mitigate risks associated with supply disruptions, emphasizing dual sourcing strategies.

• Regulatory Facilitation: The trend toward harmonization of GMP standards simplifies API approval processes for multinational companies.

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Summary of Recommended API Sources

Supplier	Location	GMP Certification	Key Strengths	Supply Focus
AbbVie Inc.	U.S./Europe	Yes	Proprietary, high standards	Licensed API supply
Aurobindo Pharma	India	Yes	Cost-effective, scalable	Generics, licensing
Dr. Reddy’s Labs	India	Yes	Quality, R&D capabilities	Bulk API
Mitsubishi Tanabe	Japan	Yes	Niche expertise	Specialty APIs
Sun Pharma	India	Yes	Market reach	Large-volume supply
Lonza	Switzerland/Global	Yes	Custom synthesis	CMO services
Catalent	U.S./Europe	Yes	Technology integration	Contract manufacturing

Note: Buyers should perform supplier audits and validation studies before establishing long-term supply agreements.

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Key Takeaways

• The primary API for URISPAS® is Darifenacin, with multiple global suppliers across North America, Europe, and Asia, each offering varying scales and levels of compliance.

• Maintaining strict adherence to GMP and obtaining regulatory approvals is non-negotiable in API sourcing for URISPAS®.

• Asian manufacturers provide cost advantages and have made significant investments in quality assurance, making them reliable sources provided due diligence is observed.

• Diversification of API sources minimizes supply risks, especially amid geopolitical and logistical uncertainties.

• Staying informed about innovations in API manufacturing and regulatory expectations ensures continual compliance and supply chain resilience.

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Frequently Asked Questions (FAQs)

1. Is Darifenacin API readily available from multiple suppliers worldwide?
Yes, Darifenacin APIs are produced by various manufacturers, including major pharmaceutical companies and CMOs, predominantly in India, Europe, and North America, ensuring competitive availability.

2. How can I verify the quality of Darifenacin API from a supplier?
Request comprehensive documentation, including Certificates of Analysis, GMP certification, stability data, and validate the supplier's audit history and regulatory compliance.

3. What are key criteria for choosing a Darifenacin API supplier?
GMP compliance, regulatory approvals, supply reliability, quality assurance processes, pricing, and the supplier's reputation are critical factors.

4. Are there patent restrictions on sourcing Darifenacin APIs?
Since Darifenacin was developed and licensed by AbbVie, patent restrictions may apply. Generic versions are available from approved manufacturers, typically under licensing agreements.

5. What trends are shaping the future of API sourcing for URISPAS®?
Enhanced quality control, sustainable manufacturing practices, supply chain diversification, and global regulatory harmonization are influential trends.

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References

[1] U.S. Pharmacopeia. (2022). USP General Chapter: Active Pharmaceutical Ingredients (APIs).

[2] European Medicines Agency. (2022). Guideline on API Quality Standards.

[3] GlobalData. (2023). Active Pharmaceutical Ingredient Market Analysis.

[4] India Brand Equity Foundation (IBEF). (2022). Pharmaceuticals & Healthcare Industry in India.

[5] Lonza Group. (2023). Contract Manufacturing Capabilities.