Suppliers and packagers for actigall

actigall

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

Suppliers for the Pharmaceutical Drug: ACTIGALL

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Introduction

Last updated: August 5, 2025

ACTIGALL, a pharmaceutical formulation primarily comprising ursodiol (ursodeoxycholic acid), is widely prescribed for the treatment of various hepatobiliary disorders, including primary biliary cirrhosis, gallstones, and certain cholestatic liver diseases. As with many specialized medications, securing reliable suppliers is crucial for pharmaceutical companies, healthcare providers, and distributors to ensure consistent drug availability, quality, and adherence to regulatory standards. This article examines the landscape of ACTIGALL suppliers, their roles, and strategic considerations for stakeholders.

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Manufacturers of Active Pharmaceutical Ingredient (API) Ursodiol

The cornerstone of ACTIGALL is the active pharmaceutical ingredient ursodiol. The API's quality, sourcing, and manufacturing are pivotal to the drug's efficacy and safety. Several global pharmaceutical companies manufacture ursodiol API, with predominant suppliers located in North America, Europe, and Asia.

1. Brand-Authorized Manufacturers

• MediGene AG / Solco Healthcare LLC
  MediGene AG, in collaboration with Solco Healthcare LLC, is a notable manufacturer of ursodiol API used specifically in ACTIGALL. Solco Healthcare holds the rights to produce generic ursodiol formulations, including for use in branded drugs like ACTIGALL, following licensing agreements with the originator.

• BASF SE
  A global chemical and pharmaceutical giant, BASF supplies raw materials and intermediates that can be used in the synthesis of ursodiol. While not a direct API manufacturer for commercial drugs, BASF’s chemical expertise supports API production processes.

• Par Pharmaceutical (a division of Endo International)
  Historically involved in the manufacturing and distribution of ursodiol APIs as part of their generics portfolio.

2. Generics and Contract Manufacturers

• Ethex Corporation
  An established API manufacturer that supplies ursodiol for generic markets; their products often undergo stringent regulatory audits.

• LFA (Laboratorios Farmacéuticos Asociados) in Latin America
  Provides licensed ursodiol APIs for regional markets, adhering to local regulatory standards.

• Other OEMs and Contract Manufacturing Organizations (CMOs)
  Several smaller CMOs across Asia (India, China, and Korea) produce ursodiol APIs under Good Manufacturing Practice (GMP) conditions, often supplying both generic formulations and private label drugs.

Regulatory and Quality Considerations

Suppliers must comply with the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other relevant regulatory bodies. Certification of GMP compliance, batch consistency, and rigorous quality control are non-negotiable criteria for reputable API suppliers of ACTIGALL.

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Formulation and Final Dosage Form Suppliers

While API manufacturing is critical, the final drug product, ACTIGALL, is typically produced by licensed pharmaceutical manufacturers who combine ursodiol with excipients, ensuring bioavailability, stability, and patient safety.

Major Licensed Pharmaceutical Manufacturers

• Solco Healthcare LLC
  A primary producer of ACTIGALL in the United States, Solco holds licensing rights for the drug and undertakes formulation, packaging, and distribution.

• Indivior
  Occasionally involved in niche formulations of ursodiol-based drugs, though their primary focus is elsewhere.

• Other Regional Manufacturers
  Various regional pharmaceutical companies manufacture ACTIGALL or equivalent formulations under license, adhering to regional regulatory standards.

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Distribution Channels and Supply Chain Dynamics

The distribution of ACTIGALL involves multiple tiers: raw material suppliers, contract manufacturers, brand owners, distributors, and healthcare providers. Supply chain integrity is vital, particularly for drugs used in critical conditions.

• Licensed Distributors
  Distributors like Cardinal Health, McKesson, and local regional suppliers play a vital role in ensuring availability across healthcare settings.

• Online and Specialty Pharmacies
  Due to the drug's niche application, some providers procure ACTIGALL through specialized distribution channels, emphasizing the importance of verifying supplier authenticity.

Supply Chain Risks

• Regulatory Non-Compliance
  Suppliers lacking GMP certification pose risks to drug quality.

• Global Supply Disruptions
  Geopolitical tensions, pandemics, and raw material shortages can impact API and formulation supply.

• Counterfeit and Substandard Products
  The importance of sourcing from verified suppliers is amplified to prevent counterfeit medications, which threaten patient safety and brand integrity.

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Strategic Considerations for Stakeholders

• For Pharmaceutical Companies: Establish robust supplier qualification programs, conduct regular audits, and develop diversified supply chains to mitigate risks.

• For Healthcare Providers: Verify supplier credentials and ensure procurement from authorized sources to maintain drug quality and safety.

• For Policymakers and Regulators: Enforce strict import and manufacturing regulations to prevent counterfeit APIs and formulations entering the supply chain.

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Emerging Trends and Opportunities

• Increasing Role of Chinese and Indian API Manufacturers: With cost advantages, Asian API producers are expanding their share in the ursodiol supply, though compliance with international standards remains critical.

• Supply Chain Transparency Initiatives: Blockchain and digital tracking are increasingly deploying to enhance transparency and traceability.

• Development of Biosimilar and Alternative Formulations: Continued innovation could influence supplier dynamics in the future.

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Conclusion

The supply of ACTIGALL hinges upon a complex network of API manufacturers, formulation specialists, and distributors. Ensuring a reliable supply chain demands diligent supplier qualification, adherence to stringent regulatory standards, and risk mitigation strategies. Given the drug’s clinical importance, all stakeholders should prioritize transparency, quality, and compliance in their sourcing decisions.

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Key Takeaways

• Multiple API Suppliers: Several global manufacturers, notably Solco Healthcare and various Asian CMOs, produce ursodiol API for ACTIGALL, subject to stringent quality controls.

• Regulatory Compliance Is Critical: Suppliers must comply with GMP standards and undergo regular audits to ensure drug safety and efficacy.

• Supply Chain Stability Is Vital: Diversified sourcing and proactive risk management mitigate disruptions in the supply of ACTIGALL.

• Regional Manufacturing Trends: Asian manufacturers are increasingly significant in global ursodiol supply, emphasizing the need for rigorous quality assurance.

• Stakeholder Vigilance: Healthcare providers and distributors should establish verified sourcing channels to prevent counterfeit or substandard products.

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FAQs

1. Who are the primary manufacturers of the ursodiol API used in ACTIGALL?
The principal API producers include Solco Healthcare LLC, MediGene AG, and various Asian Contract Manufacturing Organizations (CMOs) such as those based in India and China, all adhering to GMP standards.

2. How can stakeholders ensure the quality of ACTIGALL suppliers?
Verification involves confirming GMP certification, conducting supplier audits, reviewing quality control records, and ensuring compliance with local regulatory agencies like the FDA or EMA.

3. Are there regional differences in ACTIGALL supplier markets?
Yes. While North American and European markets rely on licensed domestic manufacturers, Asian suppliers are expanding their role due to cost efficiencies, provided they meet international quality benchmarks.

4. What are the major risks associated with ACTIGALL supply chain disruptions?
Risks include raw material shortages, geopolitical tensions, regulatory non-compliance, and counterfeit products, all of which can impact drug availability and patient safety.

5. How are emerging trends shaping the future of ACTIGALL suppliers?
Innovations such as blockchain for traceability, increased Asian API production under strict quality controls, and ongoing supply chain diversification are shaping a more resilient and transparent sourcing landscape.

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References

[1] U.S. Food and Drug Administration. "GMP Regulations for Finished Pharmaceuticals."

[2] European Medicines Agency. "Good Manufacturing Practice (GMP) guidelines."

[3] Solco Healthcare LLC. "Product Portfolio and Regulatory Approvals."

[4] Market analysis reports on global API manufacturing.

[5] Industry publications on supply chain management in pharmaceuticals.