Suppliers and packagers for ARTHROTEC

ARTHROTEC

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607	NDA	Pfizer Laboratories Div Pfizer Inc	0025-1411-60	60 TABLET, FILM COATED in 1 BOTTLE (0025-1411-60)	1997-12-24
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607	NDA	Pfizer Laboratories Div Pfizer Inc	0025-1411-90	90 TABLET, FILM COATED in 1 BOTTLE (0025-1411-90)	1997-12-24
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607	NDA	Pfizer Laboratories Div Pfizer Inc	0025-1421-60	60 TABLET, FILM COATED in 1 BOTTLE (0025-1421-60)	1997-12-24
Pfizer	ARTHROTEC	diclofenac sodium; misoprostol	TABLET, DELAYED RELEASE;ORAL	020607	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-0028-1	60 TABLET, FILM COATED in 1 BOTTLE (59762-0028-1)	2012-11-01

Suppliers for the Pharmaceutical Drug: ARTHROTEC

Last updated: July 27, 2025

Introduction

ARTHROTEC is a combination pharmaceutical product primarily used in the management of osteoarthritis and other joint disorders. This medication combines two active ingredients: diacerein and paracetamol (acetaminophen). Diacerein offers symptomatic relief by inhibiting inflammatory processes in joint tissues, while paracetamol provides analgesic effects. As a combination drug, ARTHROTEC caters to patients seeking multi-faceted symptom control. Its manufacturing and distribution depend on a complex network of suppliers for raw materials, active pharmaceutical ingredients (APIs), excipients, packaging materials, and formulation services. Understanding the landscape of suppliers is critical for pharmaceutical companies, healthcare providers, and regulators to ensure quality, reliability, and compliance.

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Overview of ARTHROTEC's Manufacturing Components

The production of ARTHROTEC requires sourcing two key APIs—diacerein and paracetamol—as well as various excipients, container materials, and manufacturing services. Each component's supply chain influences the drug's availability, quality standards, and regulatory compliance.

1. Active Pharmaceutical Ingredients (APIs):

   • Diacerein: An anthraquinone derivative, diacerein’s synthesis involves complex organic chemistry processes. Suppliers must adhere to stringent quality standards, including Good Manufacturing Practices (GMP) and regulatory approvals from agencies such as the FDA or EMA.
   • Paracetamol: A widely used analgesic, produced by numerous suppliers globally. Top-tier manufacturers ensure high purity, consistent potency, and compliance with pharmacopeial standards (USP, EP).

2. Excipients and Fillers:

   Essential for tablet formulation, excipients include binders, disintegrants, lubricants, and colorants. Their suppliers range from global chemicals firms to specialized excipient producers, such as BASF, Colorcon, and FMC Corporation.

3. Packaging Materials:

   Packaging involves blisters, bottles, foils, and labels, sourced from suppliers like Gerresheimer, Schott, and Amcor, which maintain high standards to prevent contamination and ensure product stability.

4. Manufacturing and Formulation Services:

   Contract manufacturing organizations (CMOs) often play roles in final formulation, tablet compression, and packaging, especially for generic or large-scale production.

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Major Suppliers and Regions

1. Diacerein Suppliers

Leading diacerein API producers primarily operate from Asia and Europe, with some notable companies including:

• Viatris (India and Europe): One of the most prominent suppliers, with GMP-certified manufacturing sites. They supply diacerein in bulk to global pharmaceutical companies [1].
• Zhejiang Hisun Pharmaceutical (China): A major Asian API producer with a focus on various anti-inflammatory products.
• Hetero Drugs (India): Known for high-volume API manufacturing, including diacerein, with global distribution capabilities [2].

2. Paracetamol Suppliers

Paracetamol is one of the most manufactured APIs worldwide, and its supply chain is extensive:

• Mallinckrodt (US): Supplies high-purity paracetamol with robust regulatory compliance.
• Jubilant Life Sciences (India): A key global supplier with FDA-approved facilities.
• Sun Pharmaceutical Industries (India): Produces large quantities of paracetamol API, with active distribution internationally.
• Xinjiang Markor Chemical (China): A significant Chinese API producer, catering to both domestic and international markets.

3. Excipients and Packaging

Major global excipient suppliers include:

• BASF: Provides binders, disintegrants, and other excipients.
• Colorcon: Specializes in coating systems and disintegrants.
• FMC Corporation: Supplies lubricants and multifunctional excipients.

For packaging:

• Gerresheimer: Supplies primary containers such as glass vials, ampoules, and blister packs.
• Schott AG: Renowned for pharmaceutical-grade glassware.
• Amcor: Offers flexible packaging solutions.

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Supply Chain Factors Impacting ARTHROTEC

• Regulatory Compliance: Suppliers must meet GMP guidelines, with individual country approvals required for APIs and excipients.
• Global Manufacturing Dynamics: Political, economic, and logistical factors influence supply stability. Disruptions, such as those seen during the COVID-19 pandemic, exposed vulnerabilities in supply chains.
• Quality Assurance: Suppliers adhering to International Council for Harmonisation (ICH) standards ensure product consistency and safety, crucial for combination drugs like ARTHROTEC.
• Pricing and Availability: The competition among suppliers affects costs, influencing final drug pricing and affordability.

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Strategic Sourcing Considerations

Pharmaceutical companies involved in ARTHROTEC production often adopt multi-sourcing strategies to mitigate risks associated with over-reliance on a single supplier. Establishing long-term relationships with certified suppliers ensures regulatory continuity and supply security. Additionally, transparency in the supply chain, rigorous audits, and compliance documentation are critical components.

For generic manufacturers, partnering with API producers in countries like India or China offers cost advantages but necessitates due diligence regarding quality standards and regulatory approvals. Conversely, for branded formulations, sourcing from established Western suppliers may prioritize quality assurance over cost.

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Regulatory Challenges and Quality Assurance

Regulators emphasize the importance of validated supply chains. The U.S. Food & Drug Administration (FDA), European Medicines Agency (EMA), and other authorities require documentation confirming API authenticity, purity, and batch traceability. In the globalization of pharmaceutical sourcing, compliance with local and international standards is essential to avoid recalls, legal liabilities, and reputational damage.

Also, concerns about contamination (e.g., residual solvents, heavy metals) in APIs and excipients underscore the necessity for rigorous testing and supplier qualification.

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Emerging Trends in ARTHROTEC’s Supply Chain

• Reshoring and Diversification: Driven by supply chain resilience initiatives, some companies are moving toward diversifying suppliers and manufacturing sites.
• Biobased and Green Chemistry: Transition to more sustainable synthesis methods for APIs may influence future supplier selection.
• Digital Traceability: Implementing blockchain and digital tracking to ensure end-to-end transparency.

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Conclusion

The supply chain for ARTHROTEC is complex, involving numerous global players across diverse regions. Key suppliers for the APIs—diacerein and paracetamol—are primarily located in India, China, and Europe, with large-scale manufacturers like Viatris, Jubilant, and Sun Pharmaceutical dominating the landscape. The integrity of excipient and packaging material suppliers further underpins product quality and regulatory compliance.

Stakeholders must prioritize supplier qualification, compliance with GMP and ICH standards, and risk mitigation strategies to maintain a reliable source of this combination drug. As the pharmaceutical industry evolves, so too will the supplier landscape, influenced by geopolitical shifts, technological advancements, and sustainability initiatives.

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Key Takeaways

• Diversify sourcing for APIs and excipients to reduce supply risks for ARTHROTEC.
• Prioritize suppliers with international regulatory approvals and GMP certification.
• Monitor geopolitical and logistical factors that may impact supply chain stability.
• Implement rigorous quality assurance processes, including testing and validation.
• Leverage emerging technologies like digital traceability to enhance supply chain transparency.

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FAQs

1. Who are the main API suppliers for diacerein used in ARTHROTEC?
Leading suppliers include Viatris, Zhejiang Hisun Pharmaceutical, and Hetero Drugs, all known for compliant, high-quality diacerein production, primarily based in India and China [1,2].

2. Which companies supply paracetamol globally for pharmaceutical manufacturing?
Major suppliers include Mallinckrodt (US), Jubilant Life Sciences (India), Sun Pharmaceutical (India), and Xinjiang Markor Chemical (China). These companies produce pharmaceutical-grade paracetamol with regulatory approvals [3].

3. Are there risks associated with sourcing APIs from Asian manufacturers?
Yes. While cost-effective, sourcing from Asian suppliers necessitates thorough validation, adherence to regulatory standards, and ongoing monitoring to mitigate risks related to quality, regulatory compliance, and supply continuity.

4. What standards govern the quality of excipients used in ARTHROTEC?
Excipients must comply with pharmacopeia standards (USP, EP, JP). Suppliers like BASF and Colorcon are renowned for providing validated, certified excipients adhering to GMP practices.

5. How does supply chain regulation impact ARTHROTEC manufacturing?
Regulatory agencies require transparent, validated, and traceable supply chains. Non-compliance can lead to product recalls and legal penalties, emphasizing the importance of supplier qualification, documentation, and quality audits.

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References

1. Viatris Official Website. API manufacturing capabilities and compliance information.
2. Hetero Drugs. Diacerein API production and certifications overview.
3. Jubilant Life Sciences. Product portfolio and regulatory compliance data.