Suppliers and packagers for dipentum

dipentum

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan Spclt Viatris	DIPENTUM	olsalazine sodium	CAPSULE;ORAL	019715	NDA	Viatris Specialty LLC	0037-6860-10	100 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0037-6860-10)	2015-05-15

Suppliers for the Pharmaceutical Drug: DIPENTUM

Last updated: August 6, 2025

Introduction

DIPENTUM, with the generic name mesalamine (or mesalazine), is a widely prescribed medication for treating ulcerative colitis. As an aminosalicylate, it modulates inflammation directly in the gastrointestinal tract. Ensuring an understanding of its supplier landscape is essential for stakeholders involved in manufacturing, procurement, regulatory oversight, and market analysis. This report examines the primary suppliers for DIPENTUM, focusing on manufacturing companies, geographic distribution, supply chain considerations, and market implications.

Overview of DIPENTUM and Market Position

DIPENTUM is marketed predominantly in the United States by Aurobindo Pharma and has gained recognition due to its targeted delivery in the colon for inflammatory bowel diseases. The drug’s formulation and efficacy have made it a staple in gastroenterology treatment protocols. Despite the presence of multiple generic equivalents, DIPENTUM remains a top choice, emphasizing the importance of a reliable supply chain.

Manufacturers and Supply Chain Dynamics

1. Original Development and Patent Landscape

DIPENTUM was initially developed by UCB Pharma, but the patent expiry and subsequent generic proliferation have diversified its manufacturing base. Post-patent expiration, multiple pharmaceutical companies worldwide began producing mesalamine formulations, including DIPENTUM, to meet increasing demand.

2. Major Suppliers and Manufacturers

Aurobindo Pharma – A leading global generics manufacturer, Aurobindo holds manufacturing and supply rights for DIPENTUM in several territories, notably in the U.S. and India. The company's vertically integrated supply chain encompasses active pharmaceutical ingredient (API) synthesis, formulation, and packaging, ensuring quality and capacity.

Mylan (now part of Viatris) – Historically a significant player in mesalamine production, Mylan supplied generic DIPENTUM formulations across multiple markets. Their extensive manufacturing networks in India and Europe enable large-scale supply and quick response to demand fluctuations.

Sun Pharmaceutical Industries – An Indian pharmaceutical giant, Sun Pharma produces mesalamine-based drugs, including formulations similar to DIPENTUM. Their involvement ensures a diverse supply chain, reducing dependency on a single manufacturer.

Teva Pharmaceuticals – A global leader in generics, Teva supplies mesalamine products, including DIPENTUM, in various regions. Their manufacturing sites in Israel, India, and Europe bolster global availability.

Other Notable Suppliers – Additional manufacturers include Dr. Reddy’s Laboratories, Torrent Pharmaceuticals, and Cipla, all utilizing their own production capabilities to supply DIPENTUM, especially within emerging markets.

API Production and Supply

Central to DIPENTUM's availability is the supply of active pharmaceutical ingredients. The API, mesalamine, is predominantly produced in India and China, serving as the backbone for various formulations worldwide.

Key API Suppliers:

• Advanced Pharma Ingredients: India-based manufacturer specializing in mesalamine API, supplying to multiple generic drug makers.
• Weifang Pharmaceutical Co., Ltd. – Chinese API producer with extensive mesalamine API output, exporting globally.
• Baxter Pharmaceuticals – Engaged in high-quality API production, predominantly for branded formulations.

The API’s quality, regulatory compliance, and capacity directly impact the robustness of DIPENTUM's supply chain. Disruptions in API production often cause shortages or delays, emphasizing the importance of dual-source strategies.

Geographic Distribution of Suppliers

The global landscape of DIPENTUM suppliers is characterized by:

• India: The dominant manufacturing hub for both API and finished formulations, driven by cost advantages and a large pharmaceutical manufacturing ecosystem. Companies like Aurobindo, Dr. Reddy’s, and Sun Pharma operate here.
• China: Significant for API supply, with numerous small to mid-sized producers specializing in bulk API manufacture, often supplying multiple brand owners.
• Europe and North America: Focused on formulation and packaging, with companies like Teva and Mylan establishing regional manufacturing sites to meet regulatory requirements and expedite distribution.

Regulatory and Quality Considerations

Suppliers must adhere to stringent regulatory standards, such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and other national agencies, ensuring API purity, stability, and consistent formulation quality. Any non-compliance or quality issues pose risks to supply continuity.

Market Implications and Future Outlook

Increased competition among manufacturers has driven down prices and expanded availability. However, supply chain vulnerabilities, especially related to API manufacturing and geopolitical factors, remain concerns. Notably, recent geopolitical tensions and pandemic-related disruptions have highlighted the fragility of global pharmaceutical supply chains.

To mitigate risks, pharmaceutical companies increasingly pursue dual-sourcing strategies and establish regional manufacturing capacities, particularly within North America and Europe. Ensuring supplier diversification and maintaining high compliance standards are critical for sustained supply of DIPENTUM.

Key Takeaways

• The primary suppliers of DIPENTUM are major Indian and Chinese pharmaceutical manufacturers, with regional manufacturing presence in North America and Europe.
• API production in India and China forms the backbone of the global supply chain, with geopolitical and regulatory factors influencing supply stability.
• Major formulators include Aurobindo Pharma, Mylan, Sun Pharma, and Teva, leveraging their international manufacturing networks.
• Supply chain disruptions are a persistent risk; diversification and regional manufacturing are strategic priorities.
• High regulatory standards for API and finished formulations ensure product quality but also create potential bottlenecks if non-compliance issues arise.

FAQs

Q1: Who are the leading manufacturers of DIPENTUM?
A: Leading manufacturers include Aurobindo Pharma, Mylan (Viatris), Sun Pharmaceutical Industries, and Teva Pharmaceuticals, primarily based in India, with regional manufacturing in North America and Europe.

Q2: Where is the API for DIPENTUM predominantly produced?
A: The API, mesalamine, is mainly produced in India and China, serving as the core for global distribution.

Q3: How do supply chain disruptions impact DIPENTUM availability?
A: Disruptions in API manufacturing, geopolitical tensions, or regulatory non-compliance can lead to shortages, delays, and increased prices.

Q4: Are there regional differences in supplier distribution?
A: Yes; India and China dominate API production, while North American and European manufacturers focus on formulation, packaging, and regional distribution.

Q5: What steps are companies taking to ensure continuous DIPENTUM supply?
A: Companies implement diversification strategies, establish regional manufacturing sites, and maintain high compliance standards to mitigate risks.

References

1. U.S. Food and Drug Administration. (2022). Drug Master Files and Drug Substances – MESALAMINE.
2. IQVIA. (2022). Global Pharmaceutical Market Analysis.
3. Pharma Intelligence. (2023). Mesalamine Manufacturing Landscape.
4. Aurobindo Pharma Limited. (2023). Annual Report and API manufacturing overview.
5. Teva Pharmaceuticals. (2022). Product Portfolio and Supply Chain Management.