Suppliers and packagers for generic pharmaceutical drug: MESALAMINE

MESALAMINE

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	DELZICOL	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	204412	NDA AUTHORIZED GENERIC	Greenstone LLC	59762-0117-1	180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59762-0117-1)	2019-05-10
Teva Pharms Usa	MESALAMINE	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	207873	ANDA	Teva Pharmaceuticals USA, Inc.	0093-5907-86	180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0093-5907-86)	2019-05-09
Teva Pharms Usa	MESALAMINE	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	207873	ANDA	American Health Packaging	60687-556-32	20 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-556-32) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (60687-556-33)	2021-04-20

Suppliers for the Pharmaceutical Drug: Mesalamine

Last updated: July 28, 2025

Introduction

Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is a cornerstone medication used primarily in the management of inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn’s disease. Its efficacy in reducing inflammation within the gastrointestinal tract has established it as an essential drug within the gastroenterology therapeutic landscape. As its clinical importance persists, the global supply chain for mesalamine remains pivotal for pharmaceutical companies, healthcare providers, and patients. This article details the key suppliers of mesalamine, examining manufacturing sources, market dynamics, regional contributions, and implications for industry stakeholders.

Manufacturers and Key Suppliers

Major Global Manufacturers

Several major pharmaceutical firms dominate the production of mesalamine globally. These include:

• Ferring Pharmaceuticals: A leading player in the gastrointestinal segment, Ferring produces mesalamine formulations, particularly oral delayed-release tablets and suppositories. Their products are widely available in North America, Europe, and select Asian markets.

• Salix Pharmaceuticals (a subsidiary of Bausch Health): Known for their flagship branded formulations like Asacol, Salix has historically supplied mesalamine products through proprietary formulations. Salix's manufacturing facilities are based primarily in the United States, with products distributed worldwide.

• Astellas Pharma: Acquired the rights to certain mesalamine formulations and manufacturing capacities, especially in the Asian markets. They provide various formulations, including oral and rectal preparations.

• Teva Pharmaceutical Industries: A major generic drug manufacturer offering generic versions of mesalamine in multiple formulations, including delayed-release tablets, capsules, and suppositories. Teva's extensive manufacturing network spans North America, Europe, Asia, and emerging markets.

• AbbVie: Although more prominently known for other GI therapeutics, AbbVie produces certain mesalamine formulations, reflecting a diversified product portfolio.

Generic Manufacturers

The generic segment accounts for a significant share of mesalamine supply, driven by patent expirations of branded products. Key generic suppliers include:

• Mylan (now part of Viatris): Offers various generic mesalamine products, with manufacturing facilities in the United States, India, and Europe.

• Sun Pharmaceutical Industries: An Indian pharmaceutical giant producing cost-effective generic mesalamine formulations, serving both domestic and international markets.

• Alphapharm (part of the Biopharma group): Supplies generics, particularly across Australian and Asian markets.

• Alvogen: Provides generic mesalamine products in North America and Europe.

• Cadila Pharmaceuticals: An Indian manufacturer, supplying both domestic and export markets.

Regional and Contract Manufacturers

Beyond the major pharmaceutical companies, numerous regional and contract manufacturing organizations produce mesalamine formulations under licensing agreements. These include Asian contract manufacturers who produce for global players, often at lower costs owing to manufacturing efficiencies.

Manufacturing Sources and Supply Dynamics

Raw Material Sourcing

Mesalamine's synthesis involves complex chemical processes, with manufacturing heavily reliant on high-quality raw material supply chains. Key raw materials include raw aminosalicylic acid compounds and other intermediates, often sourced from specialized chemical producers in China, India, and Europe. Disruptions in these supply chains, notably due to geopolitical issues or raw material shortages, can impact downstream manufacturing.

Manufacturing Concentration and Capacity

The manufacturing landscape for mesalamine exhibits notable concentration among a handful of multinational corporations and emerging generic producers. Capacity constraints at certain facilities can lead to supply shortages, as observed during the COVID-19 pandemic when disruptions impacted raw material availability and logistics.

Regional Supply Variations

• North America: Dominated by branded formulations from Salix and Abbott (now part of AbbVie), alongside generics from Teva and Mylan.

• Europe: Features a mix of European-based manufacturers, including Ferring and Astellas, along with generics from Teva and local producers.

• Asia: Home to significant manufacturing capacity, primarily by Indian companies like Sun Pharma and Cadila, which serve growing domestic markets and export to Europe and North America.

• Emerging Markets: Depend heavily on generic suppliers from India and China, often with limited regulatory barriers, leading to widespread availability.

Supply Chain Challenges and Market Considerations

Regulatory and Patent Challenges

Patent expirations for key branded mesalamine drugs have facilitated the entry of generic manufacturers, increasing supply diversity but also introducing variability in product quality and regulatory compliance. Maintaining consistent quality standards across different manufacturing sites remains vital.

Market Competition and Pricing

The proliferation of generic suppliers has significantly reduced the cost of mesalamine, enhancing access but exerting pressure on branded manufacturers' margins. Price competition influences procurement decisions among healthcare providers, especially in cost-sensitive markets.

Supply Security and Risk Management

Manufacturers and distributors are increasingly adopting strategic stockpiling and diversified sourcing strategies to withstand geopolitical, logistical, and raw material supply disruptions. The ongoing impact of global events, including pandemics and trade tensions, underscores the need for resilient supply chains.

Emerging Trends and Future Outlook

• Biosimilar and Novel Formulations: While mesalamine itself is chemically synthesized, new formulations—such as controlled-release or rectal delivery systems—are being developed to enhance efficacy and patient compliance.

• Manufacturing Innovations: Advances in chemical synthesis and process engineering aim to optimize production costs and quality, potentially expanding supplier capacity.

• Market Expansion: Growing prevalence of IBD globally, especially in Asia and Latin America, is projected to increase demand for mesalamine, prompting existing suppliers to scale capacity and new entrants to emerge.

• Regulatory Harmonization: Efforts to unify regulatory standards will facilitate smoother manufacturing and distribution, ensuring product quality and supply stability.

Key Takeaways

• The global mesalamine supply chain is characterized by a mix of branded pharmaceutical companies and a robust generics sector, primarily in India, China, and Europe.

• Manufacturing capacity and raw material procurement are critical factors influencing supply stability, with disruptions affecting availability and pricing.

• Patent expirations have bolstered supply diversity, but maintaining quality assurance across multiple manufacturers remains vital.

• Emerging formulations and manufacturing technologies promise to meet increasing global demand, particularly in underserved markets.

• Strategic supply chain management, including diversification and inventory resilience, is essential for stakeholders seeking reliable access to mesalamine.

FAQs

1. Who are the leading manufacturers of mesalamine globally?
Major players include Ferring Pharmaceuticals, Salix Pharmaceuticals (Bausch Health), Astellas Pharma, Teva Pharmaceutical Industries, and AbbVie, alongside numerous Indian and Asian generic manufacturers such as Sun Pharma, Cadila, and Mylan.

2. What factors influence the availability of mesalamine in different regions?
Factors include patent status, manufacturing capacity, raw material supply, regulatory approvals, and regional demand. Supply disruptions in raw materials or manufacturing facilities can lead to shortages.

3. How do generic manufacturers impact the mesalamine market?
Generic manufacturers have increased competition, lowered prices, and enhanced access by providing cost-effective alternatives. They also diversify the supply chain, reducing dependency on branded formulations.

4. What are the supply chain risks associated with mesalamine?
Risks entail raw material shortages, regulatory changes, geopolitical tensions, manufacturing disruptions, and logistical issues, all potentially affecting consistent supply.

5. Are there innovations in the manufacturing or formulation of mesalamine?
Yes, advances include controlled-release formulations, rectal delivery systems, and process improvements to enhance yield, quality, and cost-effectiveness, meeting evolving clinical needs.

References

[1] "Mesalamine." Drugs.com. Accessed March 2023.
[2] "Global Mesalamine Market Report." MarketWatch, 2022.
[3] "Pharmaceutical Manufacturing and Supply Chain Dynamics." IQVIA, 2022.
[4] "Patent Expiry and Generic Entry in the GI Segment." PharmSource, 2021.
[5] "Emerging Trends in Gastrointestinal Drug Development." Nature Reviews Drug Discovery, 2022.