Last updated: August 11, 2025
Introduction
AZULFIDINE EN-TABS, a pharmaceutical formulation primarily containing Sulfasalazine, is prescribed primarily for ulcerative colitis, Crohn’s disease, and rheumatoid arthritis. Its formulation as enteric-coated tablets (EN-TABS) ensures targeted delivery to the intestines, reducing systemic side effects. As with many established medications, a broad spectrum of manufacturers and suppliers support its global availability. This article examines key suppliers, their market roles, and factors influencing supply chain dynamics for AZULFIDINE EN-TABS.
Overview of AZULFIDINE EN-TABS and Its Market
AZULFIDINE, a branded or generic product primarily based on Sulfasalazine, benefits from decades of clinical use. Its patent status varies across regions: in some markets, it remains under patent protection, while in others, generic versions dominate. The supply chain involves active pharmaceutical ingredient (API) manufacturers, formulation and packaging entities, and distributors.
The global demand for AZULFIDINE EN-TABS hinges on the prevalence of autoimmune conditions, with estimates indicating millions of patients worldwide requiring long-term therapy. As a result, suppliers exert significant influence over production capacity, quality assurance, and distribution channels.
Major API Manufacturers for AZULFIDINE EN-TABS
The foundation of AZULFIDINE EN-TABS lies in high-quality Sulfasalazine API. The active ingredient is manufactured by several accredited companies, primarily located in regions with mature pharmaceutical sectors.
1. Piramal Pharma Solutions
Piramal is a leading global API manufacturer with a robust Sulfasalazine production portfolio. Their facilities adhere to cGMP standards, supplying APIs to both branded and generic formulations globally. Their capacity and rigorous quality controls make them a preferred partner for pharmaceutical companies seeking reliable API sources.
2. Strides Pharma Science Ltd.
An Indian pharmaceutical player with significant API manufacturing capabilities, Strides produces Sulfasalazine API for export. Their adherence to international quality norms (ICH-GMP) ensures compliance with regulatory requirements, positioning them as a notable supplier for generic AZULFIDINE EN-TABS manufacturers.
3. Teva Pharmaceuticals
A major global competitor, Teva produces Sulfasalazine API through licensed manufacturing facilities, supplying both proprietary and generic markets. Their longstanding experience ensures consistent quality and supply reliability.
4. Jiangsu Hengrui Medicine Co., Ltd.
A Chinese pharmaceutical firm engaged in high-volume API manufacturing, including Sulfasalazine. Hengrui’s competitive pricing and expanding export commands a notable role in supplying Asian markets.
5. Mylan N.V. (now part of Viatris)
Mylan’s API division supplies Sulfasalazine to various generic manufacturers worldwide, supporting diverse formulations.
Formulation and Packaging Suppliers
Beyond API manufacturing, contract manufacturing organizations (CMOs) and pharmaceutical companies produce the finished AZULFIDINE EN-TABS product, incorporating the API into enteric-coated tablets.
1. Synthon Pharmaceuticals
Based in the Netherlands, Synthon specializes in high-quality generic formulations, including Sulfasalazine products, with a focus on Europe and North America.
2. Aurobindo Pharma Limited
An Indian pharmaceutical major, Aurobindo produces and markets AZULFIDINE EN-TABS in various markets, offering integrated API-to-finished product manufacturing capabilities.
3. Sun Pharma
Sun Pharma manufactures Sulfasalazine enteric-coated tablets for multiple markets. Their extensive manufacturing network ensures supply chain robustness.
4. Pfizer Inc.
While Pfizer’s role is more prominent in branded formulations, they have historically been involved in manufacturing and distributing AZULFIDINE, especially when retaining rights to specific markets.
5. Localized and Regional Manufacturers
Many regional pharmaceutical companies in Asia, Latin America, and Eastern Europe produce AZULFIDINE EN-TABS under licensed agreements or as generic alternatives, expanding availability in emerging markets.
Distribution Channels and Key Regional Suppliers
The supply chain for AZULFIDINE EN-TABS involves multiple tiers:
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Regional Distributors: These entities supply wholesalers and pharmacies within specific countries or territories. Their choice of supplier depends on regulatory compliance, cost, and logistics.
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Wholesalers and Pharmacies: Larger distributors partner directly with manufacturers or regional suppliers and facilitate widespread access to the medication.
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Importers and Exporters: In markets lacking local manufacturing capacity, importers bring in AZULFIDINE from established suppliers.
Key Regional Suppliers:
- India: Major hub for generic production; suppliers like Aurobindo and Sun Pharma dominate locally and export globally.
- China: Hengrui and other producers supply API, with some finished product production for regional markets.
- Europe and North America: Companies like Teva and Pfizer deliver finished formulations directly to healthcare providers or through pharmacies.
Factors Influencing Supplier Selection and Supply Security
- Regulatory Approvals: Suppliers must meet stringent regulatory standards (FDA, EMA, WHO prequalification).
- Manufacturing Capacity: The ongoing demand, especially amid global health crises, strains supply; larger manufacturers with expanded capacity are preferred.
- Quality Assurance: Ensuring batch consistency and compliance with cGMP is paramount.
- Pricing and Cost-Effectiveness: Especially relevant in emerging markets, competitive pricing influences supplier relationships.
- Supply Chain Resilience: Diversified sourcing and localized manufacturing reduce disruptions.
Recent Trends and Market Dynamics
The global pharmaceutical landscape demands increased transparency and resilience. Recent trends include:
- Expansion of Indian and Chinese API manufacturing: Driven by cost advantages and capacity growth.
- Supply chain diversification: To mitigate risks amidst geopolitical tensions and pandemics.
- Regulatory harmonization: Facilitating easier approval of generics and imports across regions.
- Focus on quality assurance: Heightened scrutiny from regulators and healthcare providers.
The ongoing COVID-19 pandemic highlighted vulnerabilities in drug supply chains, prompting many companies to strengthen relationships with multiple suppliers or establish new manufacturing facilities.
Conclusion & Key Takeaways
- Multiple global players supply both API and finished AZULFIDINE EN-TABS formulations. Leading API manufacturers such as Piramal, Strides, and Teva ensure a foundation of quality and reliability.
- Regional manufacturers, especially in India and China, significantly contribute to the global supply, particularly for generics. This underscores the importance of diversified sourcing strategies.
- Quality assurance, regulatory compliance, and manufacturing capacity are key determinants for supplier selection. These factors influence the stability of supply and market competitiveness.
- Supply chain resilience is increasingly vital amid geopolitical and health crises. Companies are diversifying suppliers and investing in local manufacturing capacities.
- The growing demand for AZULFIDINE EN-TABS in emerging markets offers new opportunities for established and emerging suppliers alike.
FAQs
1. Who are the primary global suppliers of the API for AZULFIDINE EN-TABS?
Leading API suppliers include Piramal Pharma Solutions, Strides Pharma, Teva Pharmaceuticals, Jiangsu Hengrui Medicine, and Mylan. Each maintains cGMP-compliant facilities capable of consistent production.
2. Are there regional differences in AZULFIDINE EN-TABS suppliers?
Yes. In North America and Europe, branded and high-quality generics from companies like Pfizer and Sun Pharma dominate. In Asia, Indian and Chinese manufacturers produce substantial volumes, often providing cost-effective options.
3. How do supply chain disruptions affect AZULFIDINE EN-TABS availability?
Disruptions in API production or formulation manufacturing—due to geopolitical issues, pandemics, or regulatory delays—can impact availability. Diversification and regional manufacturing are strategies to mitigate these risks.
4. Can smaller or regional manufacturers supply AZULFIDINE EN-TABS?
Many regional manufacturers produce generic formulations under licensing agreements. However, their supply reliability depends on regulatory compliance, quality standards, and capacity.
5. What regulatory considerations influence supplier choices for AZULFIDINE EN-TABS?
Suppliers must meet registration requirements from relevant health authorities (FDA, EMA, WHO), maintain quality certifications, and pass regular audits—factors critical for market approval and sustained supply.
Sources:
[1] Pharmaceutical APIs market analysis, 2022.
[2] WHO Prequalified Pharmaceutical Manufacturers.
[3] Company disclosures and annual reports of Piramal, Strides, Teva, and others.
[4] Global pharmaceutical manufacturing standards and regulations.
[5] Market trends in generic drugs and active pharmaceutical ingredients.
