Suppliers and packagers for PENTASA

PENTASA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Takeda Pharms Usa	PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049	NDA	Takeda Pharmaceuticals America, Inc.	54092-189-81	240 CAPSULE in 1 BOTTLE (54092-189-81)	1993-05-10
Takeda Pharms Usa	PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049	NDA	Takeda Pharmaceuticals America, Inc.	54092-191-12	120 CAPSULE in 1 BOTTLE (54092-191-12)	2004-07-08

Suppliers for the Pharmaceutical Drug: Pentasa

Last updated: August 3, 2025

Introduction

Pentasa, the brand name for mesalamine (also known as 5-aminosalicylic acid), is a popular medication used primarily in the treatment of inflammatory bowel diseases such as Crohn’s disease and ulcerative colitis. It functions as an anti-inflammatory agent targeting the intestinal lining to reduce inflammation and manage symptoms. Given the widespread use of Pentasa, multiple pharmaceutical suppliers worldwide manufacture and distribute this medication, varying in scale, geographical reach, and regulatory compliance. This report provides an in-depth overview of key suppliers for Pentasa, analyzing their market presence, manufacturing capabilities, regulatory status, and strategic significance for industry stakeholders.

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Manufacturers and Suppliers of Pentasa

1. Ferring Pharmaceuticals

Ferring Pharmaceuticals remains the original manufacturer of Pentasa, originating from the pioneering efforts in mesalamine formulations. The company's manufacturing facilities in Europe and North America adhere to stringent Good Manufacturing Practices (GMP), ensuring high-quality production standards (1). Ferring’s extensive distribution network supplies Pentasa across multiple regions, including Europe, North America, Asia, and Africa. Its reputation is built on consistent product availability and compliance with regulatory standards, which make it a primary and reliable source for Pentasa in many markets.

2. Teva Pharmaceutical Industries

Teva, a leading global generic pharmaceutical manufacturer headquartered in Israel, supplies a generic version of mesalamine marketed under various brand names. While Teva's formulation differs from the branded Pentasa, its generic equivalents often serve as primary alternatives in regions where patent protections have expired or are not applicable (2). Teva’s manufacturing facilities in Israel, India, and Europe enable high-volume production, with distribution channels spanning North America, Europe, Asia, and Latin America.

3. Sandoz (A Novartis division)

Sandoz, a division of Novartis, is renowned for producing high-quality generic medications, including mesalamine formulations. Sandoz's capabilities include advanced formulation technologies, ensuring bioequivalence with branded drugs and compliance with pharmacopeial standards. Sandoz’s global distribution network allows broad accessibility, especially in Europe and North America (3).

4. Dr. Reddy’s Laboratories

An Indian multinational pharmaceutical company, Dr. Reddy’s produces both generic mesalamine and specific formulations tailored for different markets. Its manufacturing facilities in India and Europe, coupled with regulatory approvals in numerous countries, position Dr. Reddy’s as a prominent supplier of Pentasa alternatives (4).

5. Alkem Laboratories and Cipla

Indian pharmaceutical firms such as Alkem Laboratories and Cipla manufacture generic mesalamine formulations. Their offerings often target emerging markets where affordability and accessibility are prioritized. Both companies operate GMP-compliant facilities and possess regulatory approvals across Asia, Africa, and parts of Latin America (5).

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Regional Suppliers and Market Dynamics

North America

In the U.S. and Canada, the dominant supplier of Pentasa is Ferring Pharmaceuticals, which markets the original branded version. The availability of generics from Teva, Sandoz, and Dr. Reddy’s offers additional options, often at lower prices due to patent expirations and formulary negotiations. The presence of multiple suppliers increases market competition and ensures supply resilience.

Europe

European markets benefit from both the original Ferring product and generics from Sandoz, Teva, and local manufacturers. Regulatory frameworks such as the European Medicines Agency (EMA) ensure compliance, fostering a competitive environment with multiple licensed suppliers (6).

Asia and Middle East

Indian companies like Dr. Reddy’s, Alkem, and Cipla dominate the regional landscape, providing affordable mesalamine formulations. Regulatory approval processes differ across countries, impacting supply consistency. Local manufacturing, combined with exports, sustains regional access.

Emerging Markets

Emerging markets often rely heavily on Indian and Chinese generic manufacturers due to cost advantages. While supplies are generally sufficient, regulatory hurdles and quality assurance remain critical factors influencing supplier credibility and product quality.

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Regulatory and Quality Considerations

Manufacturers for Pentasa must meet rigorous pharmacopoeial standards — including the U.S. Pharmacopeia (USP), European Pharmacopoeia, and others. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and EMA conduct inspections to ensure manufacturing compliance. Suppliers with Good Manufacturing Practices (GMP) certification are preferred, as they guarantee product safety, efficacy, and consistency, which are essential, especially for chronic disease management involving inflammatory bowel disease.

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Supply Chain Risks and Opportunities

The reliance on multiple suppliers for Pentasa mitigates supply chain risks associated with manufacturing disruptions, geopolitical issues, and regulatory delays. The ongoing patent expirations and the rise of high-quality generics expand market opportunities, especially in cost-sensitive segments. Furthermore, technological innovations in formulation and manufacturing can improve bioavailability and reduce production costs, positioning suppliers competitively.

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Conclusion

The landscape for Pentasa suppliers is characterized by a blend of original manufacturers and a proliferation of high-quality generic producers. Ferring Pharmaceuticals remains the primary supplier of the branded drug, but significant competition originates from companies like Teva, Sandoz, Dr. Reddy’s, Cipla, and Alkem Laboratories. These suppliers operate across diverse geographies, offering expanded access at varying price points. Regulatory compliance, manufacturing capacity, and quality assurance determine success in this market.

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Key Takeaways

• Dominant Players: Ferring Pharmaceuticals maintains the primary supply of branded Pentasa, while Teva, Sandoz, Dr. Reddy’s, and Indian generics are leading suppliers for affordable alternatives.
• Global Distribution: Manufacturers operate extensive networks across North America, Europe, Asia, and emerging markets, ensuring diversified supply sources.
• Regulatory Standards: GMP compliance and adherence to pharmacopoeial standards are critical for supplier credibility and product acceptance.
• Market Dynamics: Expiration of patents and technological innovations create opportunities for generic manufacturers, increasing supply options and competitive pricing.
• Supply Chain Resilience: Multiple suppliers and regional manufacturing reduce risks associated with production disruptions and geopolitical factors.

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FAQs

Q1: What are the main suppliers of branded Pentasa?
A: Ferring Pharmaceuticals is the primary supplier of the branded version of Pentasa globally.

Q2: Which companies provide generic alternatives to Pentasa?
A: Teva, Sandoz (a Novartis division), Dr. Reddy’s Laboratories, Cipla, and Alkem Laboratories are key producers of generic mesalamine formulations.

Q3: Are there regional differences in Pentasa suppliers?
A: Yes. North America predominantly relies on Ferring, while Indian companies like Dr. Reddy’s and Cipla serve Asian and emerging markets. European markets feature both the original product and generics from multiple sources.

Q4: What regulatory standards do suppliers need to meet?
A: Suppliers must comply with GMP, and their products should meet standards set by agencies like the FDA, EMA, and pharmacopoeial authorities.

Q5: How do patent expirations influence supply options for Pentasa?
A: Patent expirations facilitate the entry of high-quality generics, increasing competition, lowering prices, and expanding access.

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Sources

1. Ferring Pharmaceuticals official website and product documentation.
2. Teva Pharmaceuticals—product portfolio and regional distribution data.
3. Sandoz (Novartis)—regulatory filings and manufacturing disclosures.
4. Dr. Reddy’s Laboratories—product approvals and manufacturing capabilities.
5. Indian Pharmaceutical Association reports on regional generic drug producers.
6. European Medicines Agency (EMA) licensing data and market reports.