Suppliers and packagers for DELZICOL

DELZICOL

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

Suppliers for the Pharmaceutical Drug: Delzicol

Last updated: July 29, 2025

Introduction

Delzicol (mesalamine delayed-release capsules) is a prescription medication primarily used for the management of ulcerative colitis—a chronic inflammatory condition of the colon. As a generic formulation of Apriso, Delzicol’s market presence relies heavily on reliable suppliers capable of consistent, high-quality production. Navigating the pharmaceutical supply landscape for Delzicol involves understanding the key manufacturing entities, their compliance status, and their role in the global distribution network.

Understanding Delzicol and Its Composition

Delzicol contains mesalamine (5-aminosalicylic acid), delivered via a delayed-release capsule designed to release the active ingredient in the colon. This targeted delivery minimizes systemic absorption and focuses therapeutic action on the inflamed mucosa of the colon — critical for effective ulcerative colitis management.

The drug’s formulation must meet strict regulatory standards, including good manufacturing practices (GMP), to ensure consistency, safety, and efficacy. Suppliers are often contract manufacturers (CMOs) or brand-name producers aligned with international pharmaceutical standards.

Major Suppliers and Manufacturers

1. Partial and Primary Manufacturers

Several players globally supply Delzicol, either directly manufacturing under license or as contract manufacturing organizations. The landscape comprises both original developers and generic producers.

• Viatris Inc. (formerly Mylan):
  As the primary supplier of generic mesalamine products in various formulations, Viatris has significant capacity and a broad distribution network for products akin to Delzicol. Their manufacturing plants are GMP-certified, and the company maintains a robust supply chain to meet global demand.

• Sun Pharmaceutical Industries Ltd.:
  An established generic manufacturer with facilities capable of producing mesalamine formulations, Sun Pharma supplies the generic mesalamine market, often under various brand labels, potentially including Delzicol's formulation.

• Meda Pharmaceuticals (now part of Mylan/Viatris):
  Historically contributed to mesalamine production, especially in delayed-release formulations, leveraging extensive manufacturing and distribution infrastructure.

• Fresenius Kabi:
  While more specialized in sterile infusion and injectable products, they also manufacture certain gastrointestinal agents, including mesalamine formulations. Their focus on quality standards makes them a reliable supplier in this sector.

2. Contract Manufacturing and Licensing Arrangements

• Many generic pharmaceutical companies source Delzicol-like formulations from contract manufacturing organizations (CMOs), which produce active pharmaceutical ingredients (APIs) and finished dosage forms under strict quality controls.

• Licensing agreements form a core part of the supply chain, with patent holders licensing manufacturing rights to regional or local producers, expanding the portfolio of suppliers in different markets.

3. API Suppliers

The core of Delzicol manufacture is the mesalamine API, sourced primarily from:

• Gisele Pharma and Motif Laboratory in India:
  These suppliers are recognized for high-quality mesalamine synthesis, adhering to international standards, and providing APIs for multiple formulations.

• Aenova Group:
  A European API manufacturer that supplies mesalamine to several finished dosage form producers.

• Zhejiang Huahai Pharmaceutical Co. (China):
  An API producer with significant capacity for mesalamine, exporting globally.

API quality directly impacts the safety and efficacy of the finished product, making selection of reputable API suppliers crucial in the supply chain.

4. Regulatory and Certification Factors

Suppliers must hold necessary certifications such as GMP compliance, ISO certifications, and drug master files (DMFs) accepted by authorities like the FDA, EMA, or other regulatory bodies. Many suppliers pursue Certificate of Suitability (CEP) or Drug Substances Master Files to facilitate regulatory approvals across markets.

Geographical Distribution of Suppliers

• India: Dominates as the primary manufacturing hub for generics and APIs, owing to cost advantages and established pharmaceutical infrastructure. Indian companies like Sun Pharma, Cadila Healthcare, and Aurobindo Pharma are significant suppliers.

• China: Increasingly vital of late, with companies like Zhejiang Huahai expanding capacity for mesalamine API.

• Europe and the US: Typically host higher-cost but highly regulated API and finished product manufacturers, including companies like Zydus Cadila and Teva Pharmaceuticals.

Regulatory Considerations and Supply Chain Risks

• Regulatory compliance is paramount; suppliers must maintain GMP certification and regularly update documentation to adhere to evolving standards.

• Supply chain disruptions due to geopolitical factors, manufacturing delays, or raw material shortages can impact availability. Recent global events, including the COVID-19 pandemic, have highlighted vulnerabilities in sourcing from certain regions.

• Quality assurance involves routine audits, certification verification, and stability data analysis to ensure adherence to safety standards.

Emerging Trends and Market Dynamics

• Localization of production: Companies are exploring regional manufacturing to mitigate supply chain risks, potentially diversifying supplier bases for Delzicol.

• Consolidation of suppliers: Larger pharmaceutical firms tend to streamline supplier networks, favoring those with proven regulatory compliance and consistent capacity.

• Increased regulation: Stricter API and finished product standards necessitate ongoing supplier audits and quality agreement enforcement.

Conclusion

Delzicol’s supply chain is characterized by a diverse array of manufacturers, with Indian and Chinese companies dominating API production and Indian-based generic companies providing finished formulations. Ensuring supplier compliance with international standards, diversifying sourcing to mitigate risks, and staying attuned to regulatory evolutions are crucial for stakeholders seeking stability in Delzicol’s availability.

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Key Takeaways

• Delzicol’s primary suppliers include Indian companies such as Sun Pharma and Aurobindo Pharma, along with Chinese API manufacturers like Zhejiang Huahai.

• Contract manufacturing and API sourcing are centrally coordinated to meet strict GMP standards, with regulatory compliance being a critical criterion.

• Geopolitical dynamics and COVID-19 have underscored the importance of diversified supply chains to maintain consistent Delzicol availability.

• Suppliers must possess necessary certifications, including GMP and DMFs, to ensure regulatory compliance across markets.

• The evolving landscape favors regionalized production and increased oversight to mitigate supply and quality risks.

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FAQs

1. Who are the main API suppliers for Delzicol?

Main API producers include Zhejiang Huahai Pharmaceutical (China), Aenova Group (Europe), and Indian manufacturers like Gisele Pharma and Motif Laboratory. Indian companies such as Sun Pharma and Aurobindo Pharma also supply finished formulations.

2. Are there approved manufacturing facilities for Delzicol in the United States?

While the original branded Delzicol was developed by Salix Pharmaceuticals, now part of Gilead Sciences, many generic versions are produced by Indian and Chinese firms supplying US markets, provided their facilities hold FDA approval via establishment inspections and DMFs.

3. How does regulatory compliance influence supplier selection?

Suppliers must meet international GMP standards and possess relevant certifications like DMFs or CEPs. Regulatory compliance ensures product safety, efficacy, and facilitates approval in various markets.

4. What risks are associated with Delzicol supply chain disruptions?

Risks include raw material shortages, geopolitical tensions, manufacturing delays, and regulatory non-compliance. Diversified supplier bases mitigate these vulnerabilities.

5. Is there a trend toward localized manufacturing for Delzicol?

Yes, to reduce supply chain risks, companies are increasingly establishing regional manufacturing subsidiaries or partnerships, expanding local production capacity, especially in North America and Europe.