Suppliers and packagers for DARIFENACIN

DARIFENACIN

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Macleods Pharms Ltd	DARIFENACIN	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	207302	ANDA	Macleods Pharmaceuticals Limited	33342-276-07	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-276-07)	2017-07-29
Macleods Pharms Ltd	DARIFENACIN	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	207302	ANDA	Macleods Pharmaceuticals Limited	33342-276-10	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-276-10)	2017-07-29
Macleods Pharms Ltd	DARIFENACIN	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	207302	ANDA	Macleods Pharmaceuticals Limited	33342-276-12	10 BLISTER PACK in 1 CARTON (33342-276-12) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2017-07-29
Macleods Pharms Ltd	DARIFENACIN	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	207302	ANDA	Macleods Pharmaceuticals Limited	33342-277-07	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-277-07)	2017-07-29

Suppliers for the Pharmaceutical Drug: Darifenacin

Last updated: August 3, 2025

Introduction

Darifenacin, marketed under brand names such as Enablex and Emselex, is a selective M3 muscarinic receptor antagonist primarily prescribed for the treatment of overactive bladder (OAB). Its pharmacological profile offers targeted symptom relief with minimal off-target effects, making it a preferred choice in urological therapeutics. As demand for OAB medications increases globally, understanding the supply chain landscape for Darifenacin becomes crucial for pharmaceutical companies, healthcare providers, and investors. This article examines the key suppliers involved in Darifenacin production, focusing on raw material providers, active pharmaceutical ingredient (API) manufacturers, and formulation partners.

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Manufacturers of Darifenacin API

The core of Darifenacin's supply chain hinges on the production of its active pharmaceutical ingredient (API). Several pharmaceutical companies and chemical suppliers globally facilitate this essential step in the drug's manufacturing process.

Lupin Limited

An Indian pharmaceutical giant, Lupin Limited has established itself as a significant API manufacturer and exporter. Lupin's capabilities span a range of sophisticated APIs, including those used for urological therapeutics. The company's extensive R&D infrastructure enables it to produce Darifenacin APIs compliant with international regulatory standards, including WHO-GMP and FDA regulations.

Sandoz (Novartis Group)

Sandoz, a division of Novartis, specializes in biosimilars and generic APIs. The company's global manufacturing facilities produce a broad portfolio of APIs, including products for urinary and neurological indications. While Sandoz's direct involvement in Darifenacin API production hasn't been publicly confirmed, their extensive portfolio suggests potential involvement either as a supplier or through licensing arrangements.

Hikma Pharmaceuticals

Hikma, based in the Middle East, is known for producing high-quality APIs used across therapeutic categories. Their API manufacturing facilities in Europe and the Middle East are certified to international standards, making Hikma a potential supplier for Darifenacin's API.

Other Emerging API Suppliers

Numerous contract manufacturing organizations (CMOs) in India, China, and Eastern Europe produce Darifenacin APIs under contract for branded or generic companies. This includes firms like Jiangsu Hengrui Medicine, Zhejiang Hisun Pharmaceutical, and many mid-size CMOs specializing in small molecule APIs.

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Raw Material Suppliers

The synthesis of Darifenacin involves multiple chemical precursors, reagents, and solvents. Suppliers of these raw materials play an integral role in ensuring high-quality and consistent API production.

Key Raw Material Suppliers:

• Merck KGaA (Germany): Supplies specialty chemicals and reagents used in pharmaceutical synthesis. Merck's high-grade substrates are used in API manufacturing, including Darifenacin precursors.

• Sigma-Aldrich (part of Merck Group): Provides a broad spectrum of chemicals, including intermediates and solvents essential for synthesis.

• Thermo Fisher Scientific: Offers reagents and chemicals for pharmaceutical synthesis, ensuring purity standards necessary for API synthesis.

• Local Chemical Suppliers: Many generic and specialty chemical suppliers in Asia provide raw materials used in API synthesis, often at competitive prices, supporting the lower-cost manufacturing of Darifenacin.

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Formulation and Final Dosage Manufacturers

Post-API production, the formulation of Darifenacin into tablets or other dosage forms involves partnerships with specialized pharmaceutical formulators equipped with technology for powder blending, compression, coating, and packaging.

Key Formulation Partners:

• Makers of Generic Darifenacin Tablets:

  • Sun Pharma: Known for its robust manufacturing and formulation capabilities in India, Sun Pharma produces Darifenacin formulations for various markets and often licenses API from multiple suppliers.

  • Dr. Reddy’s Laboratories: With a strong presence in generic pharmaceuticals, Dr. Reddy’s formulates Darifenacin tablets for export and domestic markets.

  • Aurobindo Pharma: Engaged in formulation manufacturing, Aurobindo often partners with API suppliers, including Indian and international manufacturers.

• OEM and Contract Manufacturing Organizations: Many firms provide formulation, coating, and packaging services based on APIs supplied by various manufacturers globally.

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Supply Chain Dynamics and Regulatory Considerations

The Darifenacin supply chain's complexity reflects typical small molecule pharmaceutical production, with dependencies on multiple suppliers for intermediates, APIs, and formulation. Key considerations influencing supply include:

• Regulatory Approvals: Suppliers must adhere to strict regulatory standards such as FDA, EMA, and MHRA, ensuring quality and compliance.

• Patent and Licensing Arrangements: While Darifenacin was initially patented, patent expirations in many jurisdictions have broadened manufacturing opportunities. However, licensing agreements can restrict or enable specific suppliers to operate in particular markets.

• Geopolitical Factors: Manufacturing locations in India, China, and Eastern Europe benefit from cost efficiencies but are subject to geopolitical stability and trade policies affecting supply continuity.

• Quality Assurance and Traceability: Suppliers must maintain rigorous quality management systems, including batch traceability, GMP compliance, and ISO certifications.

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Market Share and Supply Chain Outlook

As of 2023, the market is predominantly served by Asian API manufacturers and Indian formulators, with some European and North American companies contributing to specific regional supplies. The patent expiry of Darifenacin in many regions has spurred a proliferation of generic manufacturers, broadening the supplier base and enhancing supply security.

Future growth hinges on:

• Emerging Regional Markets: Expanding healthcare access in Asia and Africa increases demand, prompting new suppliers to enter the market.

• Supply Chain Resilience: Manufacturers are diversifying suppliers to mitigate risks associated with geopolitical tensions, pandemics, and logistic disruptions.

• Technological Innovations: New synthetic pathways and process optimizations are expected to lower costs and improve yields, influencing the supplier landscape.

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Key Takeaways

• Major API producers for Darifenacin include Lupin Limited, Hikma Pharmaceuticals, and CMOs in India and China.

• Raw material sourcing is diversified among global chemical suppliers, emphasizing high purity and compliance standards.

• Formulation expertise is concentrated among Indian generics manufacturers such as Sun Pharma, Dr. Reddy’s, and Aurobindo Pharma.

• Regulatory standards and geopolitical factors significantly influence supplier selection and supply chain stability.

• The expanding generic market, coupled with patent expirations, is leading to increased supplier competition and diversification.

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FAQs

1. Who are the leading API suppliers for Darifenacin globally?
   Major API manufacturers include Lupin Limited (India), Hikma Pharmaceuticals (Middle East), and various CMOs across Asia and Eastern Europe. These companies have the capacity to produce high-quality Darifenacin APIs adhering to international standards.

2. What raw materials are involved in Darifenacin synthesis, and who supplies them?
   The synthesis involves intermediates, solvents, and reagents supplied by companies such as Merck KGaA, Sigma-Aldrich, and Thermo Fisher Scientific, primarily based in Europe and North America.

3. Are there regional differences in Darifenacin suppliers?
   Yes. Indian and Chinese manufacturers dominate the generic API and formulation markets. European and North American companies tend to supply higher-cost, specialized APIs or finished dosage forms for regulated markets.

4. How do regulatory standards impact Darifenacin's supply chain?
   Suppliers must comply with GMP, FDA, EMA, and other relevant standards to ensure drug safety and efficacy. This regulation influences supplier selection, quality control measures, and geographical sourcing strategies.

5. What is the future outlook for Darifenacin supplier diversity?
   The expiration of patents and increased demand will likely foster a more competitive and diversified supply chain, with new entrants from emerging markets and process innovations reducing costs and supply risks.

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References

[1] U.S. Food & Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations.
[2] WHO. (2019). Good Manufacturing Practices for Medicinal Products.
[3] MarketWatch. (2023). Global Overactive Bladder Market Analysis.
[4] Indian Pharmaceutical Association. (2021). API Manufacturing Landscape.
[5] European Medicines Agency. (2022). Regulatory Guidelines for Small Molecule APIs.