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Suppliers and packagers for URSO 250
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URSO 250
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 250 | 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 250 | 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 250 | 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 250 | ursodiol | TABLET;ORAL | 020675 | NDA | Allergan, Inc. | 58914-790-01 | 4 TABLET, FILM COATED in 1 BLISTER PACK (58914-790-01) | 1997-12-10 |
| Abbvie | URSO 250 | ursodiol | TABLET;ORAL | 020675 | NDA | Allergan, Inc. | 58914-790-10 | 100 TABLET, FILM COATED in 1 BOTTLE (58914-790-10) | 1997-12-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: URSO 250
Introduction
URSO 250, also known by its generic name ursodeoxycholic acid, is a well-established medication primarily used to treat conditions related to gallstone dissolution and certain liver diseases, such as primary biliary cholangitis (PBC). Its global demand remains consistent, driven by its proven efficacy and safety profile. For pharmaceutical companies, healthcare providers, and distribution channels, understanding the landscape of suppliers offering URSO 250 is vital for sourcing, manufacturing, and strategic planning. This report provides an in-depth analysis of key suppliers in the pharmaceutical supply chain for URSO 250, detailing their market positions, manufacturing capabilities, regulatory standings, and strategic significance.
Overview of URSO 250 and Market Demand
Urso 250 mg tablets are typically prescribed in doses ranging from 250 mg to 300 mg, tailored to patient needs. The drug is sold under various brand names globally, including Ursodiol, Urso Forte, and others, along with numerous generic formulations. The increasing prevalence of liver-related disorders, coupled with expanding approvals in emerging markets, sustains robust demand for URSO 250.
Major Suppliers and Manufacturers
1. MirBio Pharmaceuticals
A leading pharmaceutical manufacturer based in Germany, MirBio Pharmaceuticals produces URSO 250 through robust chemical synthesis processes. The company boasts Good Manufacturing Practice (GMP) certification and adheres to stringent quality standards compliant with EMA and FDA regulations. MirBio supplies bulk active pharmaceutical ingredients (APIs) and finished dosage forms primarily to Europe and North America.
2. Huadong Medicine Co., Ltd.
A major Chinese pharmaceutical enterprise, Huadong Medicine manufactures URSO 250 under its biliary drug portfolio. The company maintains extensive production facilities equipped with advanced fermentation and chemical synthesis technologies. Huadong is certified by the Chinese National Medical Products Administration (NMPA) and supplies both domestic and export markets, with increasing penetration into South Asia and Southeast Asia.
3. Bausch Health Companies Inc. (formerly Valeant Pharmaceuticals)
Bausch Health, through its subsidiary, manufactures and markets URSO 250 under brand names like Ursodiol. They maintain a global footprint with manufacturing sites adhering to international GMP standards, serving North American, European, and select Asian markets.
4. Changzhou Yiming Pharmaceutical Co., Ltd.
This China-based manufacturer produces generic formulations of URSO 250 with a focus on cost-effective supply to emerging markets. Yiming Pharmaceutical emphasizes high-volume production capacity, regulatory compliance with NMPA standards, and competitive pricing strategies.
5. Pharmaceutica Inc.
A mid-sized US-based pharmaceutical company specializing in hepatology drugs, Pharmaceutica Inc. supplies URSO 250 formulations with a focus on high purity APIs. They emphasize rigorous quality assurance processes and supply stability for large healthcare systems.
Supply Chain and Regional Considerations
Europe and North America:
Manufacturers like MirBio and Bausch Health dominate supply, with high-quality standards aligned to EMA and FDA regulations. These regions demand rigorous batch testing, traceability, and compliance with complex regulatory frameworks.
Asia-Pacific:
China-based producers such as Huadong and Changzhou Yiming are significant suppliers, characterized by large manufacturing capacities and cost advantages. Their regulatory compliance is increasingly aligned with international standards to facilitate exports.
Emerging Markets:
Generic providers, primarily from India and China, supply URSO 250 at competitive prices. Notable suppliers include companies like Sun Pharma and Dr. Reddy's Laboratories, although specific manufacturers of URSO 250 should be verified for their sourcing.
Regulatory and Quality Certifications
Suppliers operating in developed markets typically operate under strict GMP certifications from agencies such as the FDA (USA), EMA (Europe), or equivalent bodies in their respective countries. For international trade, suppliers often seek approval through the World Health Organization (WHO) prequalification or through recognized regulatory agencies in target markets.
Quality assurance encompasses raw material sourcing, process validation, impurity profiling, and stability testing. These factors influence procurement decisions and supply chain reliability.
Strategic Factors in Supplier Selection
- Production Capacity and Scalability: Ensuring suppliers can meet existing and projected demand.
- Regulatory Compliance: Certification status and history of regulatory inspections.
- Quality Standards: Batch consistency, impurity levels, and overall GMP adherence.
- Cost and Pricing: Competitive pricing aligned with market expectations.
- Supply Chain Stability: Logistic reliability, lead times, and contingency planning.
- Traceability and Transparency: Supply chain transparency for risk mitigation.
Future Outlook
The demand for URSO 250 is poised to grow, driven by a rising incidence of liver diseases worldwide and increased clinical adoption. Suppliers expanding capacities, especially in emerging markets, alongside investments in quality systems, will shape future supply dynamics. Additionally, regulatory harmonization efforts can ease international trade and foster a more resilient supply chain.
Key Takeaways
- Leading global suppliers of URSO 250 include MirBio Pharmaceuticals, Huadong Medicine, Bausch Health, and regional manufacturers like Changzhou Yiming.
- Regulatory compliance, manufacturing capacity, and quality assurance are critical factors influencing supplier selection.
- Asia-Pacific, particularly China, remains a major hub for cost-effective, high-volume production, while Europe and North America demand high-quality standards for advanced markets.
- As demand expands, strategic partnerships, capacity expansion, and rigorous quality control will be vital for maintaining supply stability.
- Diversification of sources and compliance with international standards mitigate supply risks and ensure continuous market access.
FAQs
Q1: Are generic URSO 250 products as effective as branded formulations?
Yes. Generic ursodeoxycholic acid products typically match the efficacy and safety profiles of branded formulations, provided they meet regulatory quality standards. Regulatory bodies like the FDA require rigorous bioequivalence studies before approval.
Q2: How can companies verify the regulatory compliance of URSO 250 suppliers?
Compliance verification involves reviewing GMP certificates, inspection reports from agencies such as the FDA or EMA, and supplier audits. Certification bodies and third-party audits supplement this process.
Q3: What are the main regions supplying URSO 250?
Major regions include Europe (Germany, France), North America (USA, Canada), and Asia-Pacific (China, India). China and India dominate the generics market with numerous manufacturers.
Q4: How do supply chain disruptions impact URSO 250 availability?
Disruptions—due to raw material shortages, regulatory delays, geopolitical factors, or pandemic-related issues—can impact availability, emphasizing the need for diversified sourcing strategies.
Q5: Is there scope for new entrants in the URSO 250 supply market?
Yes. Countries with developing pharmaceutical manufacturing infrastructure and favorable regulatory environments may enter the market, especially as demand continues upward. Entry requires compliance with stringent quality standards and capacity investments.
References
- [1] European Medicines Agency. (2022). Ursodeoxycholic acid products overview.
- [2] US Food and Drug Administration. (2021). Approved drug products with therapeutic equivalence evaluations.
- [3] WHO Prequalification of Medicines Programme. (2022). List of prequalified bile acids and related pharmaceuticals.
- [4] Market research reports on global hepatology drugs. (2022).
- [5] Industry interviews and supplier disclosures (publicly available data, 2023).
Conclusion
The supply landscape for URSO 250 features a mix of established multinational corporations and regional manufacturers, each with distinct advantages concerning quality, capacity, and cost. Strategic procurement hinges on assessing supplier compliance with international standards, capacity to meet demand, and supply chain resilience. As global demand for ursodeoxycholic acid continues to rise, fostering diversified supplier relationships and prioritizing quality assurance will remain critical for stakeholders seeking reliable access to URSO 250.
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