Suppliers and packagers for generic pharmaceutical drug: URSODIOL

URSODIOL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Teva Branded Pharm	ACTIGALL	ursodiol	CAPSULE;ORAL	019594	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	0591-3159-01	100 CAPSULE in 1 BOTTLE (0591-3159-01)	1987-12-31
Teva Branded Pharm	ACTIGALL	ursodiol	CAPSULE;ORAL	019594	NDA AUTHORIZED GENERIC	AvKARE	42291-923-01	100 CAPSULE in 1 BOTTLE (42291-923-01)	2023-07-18
Abhai Llc	URSODIOL	ursodiol	CAPSULE;ORAL	210707	ANDA	KVK-Tech, Inc.	10702-237-01	100 CAPSULE in 1 BOTTLE (10702-237-01)	2018-05-17
Abhai Llc	URSODIOL	ursodiol	CAPSULE;ORAL	210707	ANDA	PD-Rx Pharmaceuticals, Inc.	43063-871-01	100 CAPSULE in 1 BOTTLE, PLASTIC (43063-871-01)	2018-05-17

URSODIOL Drug Supplier Landscape

Last updated: February 19, 2026

This report analyzes key suppliers for Ursodiol, an established bile acid therapy. The market is characterized by a limited number of active pharmaceutical ingredient (API) manufacturers and a more dispersed network of finished dosage form (FDF) producers. Key considerations for procurement include regulatory compliance, production capacity, and quality assurance.

Who are the primary API manufacturers of Ursodiol?

The manufacturing of Ursodiol API is concentrated among a few established chemical and pharmaceutical companies. These suppliers are critical for the foundational production of the drug substance, requiring strict adherence to Good Manufacturing Practices (GMP) and often holding Drug Master Files (DMFs) with regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Manufacturer Name	Country of Origin	Primary Focus	Key Certifications/Filings
Dipharma S.p.A.	Italy	API manufacturing	US DMF, EU CEP
Hubei Biocause Pharmaceutical Co., Ltd.	China	API manufacturing	US DMF, EDQM Certificates of Suitability (CEP)
Unipharma GmbH	Germany	API manufacturing	EU GMP
Nantong Hengxin Pharmaceutical Co., Ltd.	China	API manufacturing	US DMF, EDQM CEP

Dipharma S.p.A. is a significant global player in the production of APIs for various therapeutic areas, including bile acid derivatives like Ursodiol. Their facilities are subject to regular inspections by international regulatory bodies. Hubei Biocause Pharmaceutical Co., Ltd. is another prominent supplier, particularly from the Asian market, with a substantial production capacity and a history of supplying to regulated markets. Unipharma GmbH focuses on high-quality API production within Europe, emphasizing stringent quality control. Nantong Hengxin Pharmaceutical Co., Ltd. is also a notable Chinese manufacturer with established regulatory filings.

What are the characteristics of Ursodiol API production?

Ursodiol (also known as ursodeoxycholic acid) is a naturally occurring bile acid. Its synthesis typically involves multi-step chemical processes. The purification and crystallization steps are critical to achieve the required pharmaceutical grade, ensuring minimal impurities and consistent polymorphic forms.

• Synthetic Route: The synthesis of Ursodiol generally starts from cholic acid or deoxycholic acid, which are extracted from animal bile or produced synthetically. Chemical modification steps are employed to convert these precursors into Ursodiol.
• Quality Control: API manufacturers implement rigorous quality control measures at each stage of production. This includes testing for chemical purity, related substances, residual solvents, heavy metals, and microbial contamination. Analytical methods such as High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) are routinely used.
• Regulatory Dossiers: Manufacturers typically maintain detailed regulatory documentation, including DMFs in the US and CEPs in Europe. These filings provide comprehensive information on the manufacturing process, quality control procedures, and stability data, which are reviewed by regulatory authorities when a drug product application is submitted.
• Production Capacity: Global demand for Ursodiol API is met by a relatively stable number of manufacturers. Capacity can influence lead times and pricing, particularly during periods of high demand or supply chain disruptions. Leading manufacturers often have multi-ton production capabilities.

Which companies produce Ursodiol finished dosage forms (FDFs)?

The FDF market for Ursodiol is more fragmented, with numerous pharmaceutical companies worldwide formulating and marketing the drug in various strengths and dosage forms. These companies source their Ursodiol API from the API manufacturers listed previously.

Company Name	Country of Operations	Product Offerings	Regulatory Approvals (Example)
AbbVie Inc.	Global	Ursodiol capsules (e.g., Urso®)	US FDA, EMA
Mylan N.V. (Viatris)	Global	Ursodiol tablets and capsules (generic versions)	US FDA, EMA
Teva Pharmaceutical Industries Ltd.	Global	Ursodiol tablets and capsules (generic versions)	US FDA, EMA
Zydus Cadila	India, Global	Ursodiol capsules and tablets (generic versions)	US FDA, EMA, CDSCO (India)
Sanofi	Global	Ursodiol tablets and capsules (generic versions)	US FDA, EMA

AbbVie holds a historically significant position with its branded Ursodiol products. However, the market is now largely dominated by generic manufacturers such as Viatris (formerly Mylan), Teva, Zydus Cadila, and Sanofi. These companies focus on producing bioequivalent generic versions, making the drug accessible in numerous global markets. The choice of FDF manufacturer often depends on regional market access, distribution networks, and specific product formulations (e.g., immediate-release vs. controlled-release, capsule vs. tablet).

What are the regulatory requirements for Ursodiol suppliers?

Suppliers of Ursodiol, both API and FDF, must comply with stringent global regulatory standards to ensure product safety, efficacy, and quality.

• Good Manufacturing Practices (GMP): All manufacturing facilities for both API and FDF must adhere to cGMP guidelines as stipulated by regulatory bodies like the FDA (21 CFR Parts 210 and 211), EMA (EudraLex Volume 4), and national health authorities. This covers all aspects of production, from raw material control to finished product release.
• Drug Master Files (DMFs) / Certificates of Suitability (CEPs): API manufacturers must file comprehensive documentation with regulatory agencies. US DMFs allow the FDA to review confidential manufacturing information when referenced in a drug product application. EU CEPs, issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM), demonstrate compliance with the European Pharmacopoeia and facilitate registration across member states.
• Pharmacopoeial Compliance: Ursodiol API and finished products must meet the specifications outlined in major pharmacopoeias, including the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP). These monographs define identity, purity, assay, and impurity limits.
• Site Inspections: Facilities are subject to routine inspections by regulatory authorities to verify ongoing compliance with GMP and other applicable regulations. Successful inspection outcomes are critical for continued market access.
• Quality Agreements: Pharmaceutical companies sourcing API or FDF often establish detailed Quality Agreements with their suppliers. These legally binding documents define the responsibilities of each party concerning quality control, change management, issue resolution, and supply chain security.

What are the supply chain considerations for Ursodiol?

The supply chain for Ursodiol involves managing the procurement of raw materials, the manufacturing of API, and the subsequent formulation and distribution of finished drug products. Several factors influence supply chain reliability and cost.

• Geographic Concentration of API Manufacturing: A significant portion of Ursodiol API manufacturing is based in China and India. This concentration can lead to potential risks related to geopolitical events, trade policies, natural disasters, or localized regulatory enforcement actions impacting production.
• Dual Sourcing Strategy: To mitigate supply chain risks, pharmaceutical companies often employ a dual sourcing strategy for critical APIs like Ursodiol. This involves qualifying and utilizing at least two different API manufacturers to ensure continuity of supply in case of disruptions from one supplier.
• Lead Times and Inventory Management: The lead time for Ursodiol API can range from several weeks to months, depending on the manufacturer's capacity and current order backlog. Effective inventory management is crucial to avoid stock-outs or excessive carrying costs.
• Transportation and Logistics: Ensuring the integrity of the API and FDF during transit is paramount. This includes maintaining appropriate temperature and humidity controls, secure packaging, and reliable logistics partners, especially for international shipments.
• Cost Dynamics: API costs are influenced by raw material prices, manufacturing efficiency, regulatory compliance burdens, and market competition. Genericization of Ursodiol has led to increased price pressure on both API and FDF.

What is the competitive landscape for Ursodiol API?

The competitive landscape for Ursodiol API is characterized by a stable base of qualified manufacturers. Entry barriers are high due to the significant investment required for GMP-compliant facilities, robust quality systems, and successful regulatory filings (DMFs/CEPs).

• Key Differentiators: Manufacturers compete on price, quality consistency, regulatory support, and reliability of supply. Companies with strong regulatory track records and proven long-term supply capabilities often secure preferred supplier status.
• Market Share: While precise market share data is proprietary, manufacturers with substantial production capacity and established relationships with major generic and branded pharmaceutical companies are likely to hold significant portions of the global Ursodiol API market.
• Impact of Genericization: The widespread availability of generic Ursodiol FDFs has intensified competition among API suppliers to offer cost-effective solutions to formulators. This drives efficiency and cost optimization in manufacturing processes.
• Emerging Manufacturers: While the market is mature, there is always potential for new entrants, particularly from regions with developing pharmaceutical manufacturing sectors, provided they can meet the stringent regulatory and quality requirements. However, the established players have significant advantages in terms of experience and regulatory acceptance.

Key Takeaways

The supply chain for Ursodiol is structured with a consolidated base of qualified API manufacturers and a diverse array of global FDF producers. Key suppliers for Ursodiol API include Dipharma S.p.A., Hubei Biocause Pharmaceutical Co., Ltd., Unipharma GmbH, and Nantong Hengxin Pharmaceutical Co., Ltd., all of whom maintain critical regulatory filings such as US DMFs and EU CEPs. Finished dosage form manufacturing is led by global pharmaceutical companies and a multitude of generic manufacturers, including Viatris, Teva, and Zydus Cadila, who rely on these API suppliers. Regulatory compliance, particularly adherence to GMP, pharmacopoeial standards, and maintaining up-to-date regulatory dossiers, is a non-negotiable requirement for all participants. Supply chain risks are managed through dual sourcing strategies, robust inventory control, and diligent logistics management, with geographical concentration of API manufacturing presenting a key consideration. The competitive environment for Ursodiol API is defined by established players emphasizing quality, regulatory support, and cost-effectiveness in response to the generic FDF market.

FAQs

1. What is the typical lead time for Ursodiol API orders from major manufacturers? Typical lead times for Ursodiol API orders from major manufacturers can range from 8 to 16 weeks, depending on current production schedules, order volume, and supplier capacity. Expedited orders may be possible but often incur premium pricing.

2. Are there any significant API supply disruptions anticipated for Ursodiol in the near future? As of the latest market intelligence, there are no widespread, publicly announced significant supply disruptions anticipated for Ursodiol API. However, individual manufacturers may experience localized challenges due to operational issues or regulatory actions. Continuous monitoring of supplier performance and regulatory news is advised.

3. What are the main quality attributes that differentiate Ursodiol API suppliers? Key quality differentiators include the purity profile of the API (e.g., specific impurity limits), the consistency of polymorphic form, particle size distribution, and the absence of residual solvents and elemental impurities. Suppliers with comprehensive analytical testing and robust batch-to-batch consistency are favored.

4. Can pharmaceutical companies audit Ursodiol API manufacturing sites? Yes, pharmaceutical companies that intend to source Ursodiol API typically have the right to audit the manufacturing sites of their potential or existing suppliers to verify compliance with GMP and their specific quality requirements. These audits are a standard part of supplier qualification and ongoing quality management.

5. What impact does the price of raw materials have on Ursodiol API costs? The cost of primary raw materials used in the synthesis of Ursodiol, such as cholic acid or its precursors, can have a notable impact on the overall cost of the API. Fluctuations in the availability and pricing of these upstream components can influence Ursodiol API pricing, though manufacturing efficiency and economies of scale also play significant roles.

Citations

[1] U.S. Food and Drug Administration. (n.d.). 21 CFR Part 210 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=210.1 [2] European Medicines Agency. (n.d.). EudraLex - The Rules Governing Medicinal Products in the European Union. Volume 4. Good Manufacturing Practice. Retrieved from https://ec.europa.eu/health/human-use/eu-legislation/eudralex/volume-4_en [3] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificates of Suitability (CEP). Retrieved from https://www.edqm.eu/en/certificates-suitability-cep [4] United States Pharmacopeia. (n.d.). USP-NF Online. Retrieved from https://www.uspnf.com/ [5] European Directorate for the Quality of Medicines & HealthCare. (n.d.). European Pharmacopoeia. Retrieved from https://www.edqm.eu/en/european-pharmacopoeia [6] Publicly available company websites and product portfolios for AbbVie, Viatris, Teva Pharmaceutical Industries Ltd., Zydus Cadila, Sanofi, Dipharma S.p.A., Hubei Biocause Pharmaceutical Co., Ltd., Unipharma GmbH, and Nantong Hengxin Pharmaceutical Co., Ltd. (Accessed throughout 2023-2024).