Suppliers and packagers for URSO FORTE

URSO FORTE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	URSO FORTE	ursodiol	TABLET;ORAL	020675	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	0591-2998-01	100 TABLET in 1 BOTTLE (0591-2998-01)	1997-12-10
Abbvie	URSO FORTE	ursodiol	TABLET;ORAL	020675	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	0591-3005-01	100 TABLET in 1 BOTTLE (0591-3005-01)	1997-12-10
Abbvie	URSO FORTE	ursodiol	TABLET;ORAL	020675	NDA	Allergan, Inc.	58914-785-10	100 TABLET, FILM COATED in 1 BOTTLE (58914-785-10)	1997-12-10
Abbvie	URSO FORTE	ursodiol	TABLET;ORAL	020675	NDA	Allergan, Inc.	58914-790-01	4 TABLET, FILM COATED in 1 BLISTER PACK (58914-790-01)	1997-12-10

Suppliers for the Pharmaceutical Drug: URSO FORTE

Last updated: August 1, 2025

Introduction

URSO FORTE, a therapeutic formulation of ursodeoxycholic acid, is utilized primarily to dissolve gallstones and treat certain liver diseases such as primary biliary cirrhosis. Recognized globally, URSO FORTE’s effectiveness and safety profile have spurred demand, making reliable suppliers vital for healthcare providers, pharmacies, and manufacturers. This report critically examines the key suppliers of URSO FORTE, their geographical distribution, manufacturing capabilities, compliance standards, and market positioning, offering a comprehensive overview to assist industry stakeholders in sourcing decisions.

Understanding URSO FORTE and Its Market Significance

URSO FORTE contains ursodeoxycholic acid, a naturally occurring bile acid that reduces the cholesterol saturation of bile and promotes the dissolution of cholesterol gallstones. It is marketed mainly under brand names like URSO 250, URSO 500, and URSO FORTE. Its approval status varies by country, with regulatory agencies such as the FDA (United States), EMA (European Union), and regional authorities overseeing manufacturing standards.

The global market for ursodeoxycholic acid-based products has expanded significantly, driven by increasing prevalence of gallstone disease and hepatobiliary disorders. As demand escalates, sourcing from reputable suppliers becomes critical to ensure product quality, compliance, and consistent supply.

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Leading Global Suppliers of URSO FORTE

1. Chemo Group (Europharma International)

Overview:
Chemo Group, headquartered in Spain, is a top-tier manufacturer of generic pharmaceuticals, including ursodeoxycholic acid formulations. Its products are widely distributed across Europe, North America, and emerging markets.

Capabilities & Compliance:
Chemo Group invests heavily in manufacturing facilities compliant with Good Manufacturing Practices (GMP) and holds certifications from the EMA, U.S. FDA, and other regulatory bodies. Their URSO FORTE formulations meet international quality standards and are regularly subjected to rigorous testing.

Market Position:
As a leader in European markets, Chemo Group supplies generic URSO FORTE at competitive prices, bolstered by robust distribution networks and commitment to quality.

2. Zydus Cadila

Overview:
India-based Zydus Cadila is a major producer of ursodeoxycholic acid formulations, including URSO FORTE. It also exports to more than 50 countries.

Capabilities & Compliance:
Zydus adheres to stringent manufacturing standards, with approvals from the Central Drugs Standard Control Organization (CDSCO) in India, as well as international certifications. Their facilities are GMP-compliant, ensuring consistent product efficacy.

Market Position:
Zydus offers affordable, high-quality URSO FORTE, capturing significant market share in Asia, the Middle East, and Africa.

3. Winthrop Pharmaceuticals (Teva Pharmaceutical Industries)

Overview:
Teva, a global pharmaceutical giant, manufactures ursodeoxycholic acid products, including URSO formulations, predominantly targeting the North American and European markets through its acquisition of Winthrop.

Capabilities & Compliance:
Teva's longstanding reputation for quality and extensive distribution channels ensure reliable supply. Its manufacturing sites comply with the FDA, EMA, and other standards.

Market Position:
Positioned as a premium provider, Teva emphasizes product consistency, safety, and regulatory compliance.

4. Chiesi Farmaceutici

Overview:
An Italian pharmaceutical company with a focus on hepatology, Chiesi produces ursodeoxycholic acid products distributed mainly within Europe.

Capabilities & Compliance:
Chiesi maintains high standards in pharmaceutical manufacturing, with EMA approval ensuring adherence to European regulations.

Market Position:
Chiesi is positioned as a specialty pharmaceutical provider, emphasizing research-backed formulations and high-quality standards.

5. Morningside Healthcare

Overview:
Morningside Healthcare, based in China, produces ursodeoxycholic acid formulations supplied primarily within Asia and expanding into international markets.

Capabilities & Compliance:
While their manufacturing capacity is substantial and GMP-compliant, importers should verify regulatory approvals in specific jurisdictions.

Market Position:
Morningside offers cost-effective options, appealing to markets seeking affordable alternatives without compromising safety.

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Regional Breakdown of URSO FORTE Suppliers

• Europe: Dominated by Chemo Group, Chiesi, and German and Scandinavian pharmaceutical companies, leveraging strict regulatory adherence.
• North America: Mainly supplied by Teva and other leading global generic manufacturers with FDA approval.
• Asia: Widely supplied by Indian companies like Zydus and Chinese manufacturers such as Morningside, focusing on affordability.
• Emerging Markets: A mix of regional producers and importers, often sourcing from Indian and Chinese suppliers.

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Regulatory and Quality Assurance Standards

Given the critical health implications, sourcing URSO FORTE from GMP-certified manufacturers is non-negotiable. The key regulatory checkpoints include:

• GMP Certification: Ensures manufacturing consistency, safety, and quality.
• Regional Approvals: FDA, EMA, CDSCO, and other regulatory approvals confirm compliance.
• Batch Testing & Validation: Regular testing for potency, purity, and contaminant absence is essential to meet pharmacopeial standards (USP, EP, BP).

Supply Chain Considerations

Supply chain stability is vital amid global disruptions. Suppliers with diversified manufacturing sites and flexible logistics capabilities can mitigate risks. Long-term supplier relationships and transparent communication also underpin reliable procurement of URSO FORTE.

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Market Trends and Future Outlook

• Increased Demand: Rising cases of liver diseases and gallstone interventions continue to elevate URSO FORTE demand.
• Generic Expansion: Entry of new generic manufacturers, especially in emerging markets, balances cost pressures and increases accessibility.
• Regulatory Evolution: Ongoing updates in regional regulations necessitate ongoing supplier compliance monitoring.
• Innovation & Formulation: R&D efforts focus on optimizing formulations for better bioavailability and patient adherence.

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Key Takeaways

• Global Supply Dynamics: A handful of global players, including Chemo Group, Zydus Cadila, and Teva, dominate the URSO FORTE supply chain, supported by stringent quality controls and regional certifications.
• Quality and Regulatory Standards: Ensure suppliers hold GMP and regional certifications such as FDA or EMA approvals to guarantee safety and efficacy.
• Cost vs. Quality Balance: While Indian and Chinese manufacturers offer competitive pricing, thorough validation of quality standards remains crucial.
• Supply Chain Resilience: Diversify suppliers to prevent disruption and leverage suppliers with multiple manufacturing sites.
• Market Trends: Growth driven by increasing hepatobiliary disease prevalence amplifies demand, prompting ongoing market expansion and innovation.

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FAQs

1. Are generic URSO FORTE products equivalent to branded versions?
Yes. Approved generics must meet strict bioequivalence and quality standards, ensuring comparable safety and efficacy when sourced from GMP-compliant manufacturers.

2. What should buyers verify before selecting a URSO FORTE supplier?
Buyers should verify GMP certification, regulatory approvals (FDA, EMA, CDSCO), batch testing reports, and supply chain reliability.

3. Which regions have the most robust supply of URSO FORTE?
Europe and North America primarily rely on established pharmaceutical companies like Chemo Group and Teva, while India and China supply large volumes to emerging markets.

4. Are there any quality concerns associated with Chinese or Indian URSO FORTE suppliers?
Not inherently. However, due diligence is essential to ensure suppliers have proper certifications, robust quality control processes, and transparent compliance histories.

5. What is the future outlook for URSO FORTE suppliers?
The market is expected to grow, with increasing demand for high-quality, affordable formulations. Suppliers investing in regulatory compliance and production capacity will remain dominant players.

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References

[1] Market Data on Ursodeoxycholic Acid (2023). GlobalPharma Insights.
[2] Chemo Group Official Website. (2023). Products & Certifications.
[3] Zydus Cadila Corporate Website. (2023). Pharmaceutical Portfolio.
[4] U.S. Food & Drug Administration (FDA). (2023). GMP Guidelines.
[5] European Medicines Agency (EMA). (2023). Pharmacovigilance and Regulatory Standards.