Suppliers and packagers for gengraf

gengraf

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	GENGRAF	cyclosporine	CAPSULE;ORAL	065003	ANDA	AbbVie Inc.	0074-3108-32	3 BLISTER PACK in 1 CARTON (0074-3108-32) / 10 CAPSULE in 1 BLISTER PACK	2015-11-01
Abbvie	GENGRAF	cyclosporine	CAPSULE;ORAL	065003	ANDA	AbbVie Inc.	0074-3109-32	5 BLISTER PACK in 1 CARTON (0074-3109-32) / 6 CAPSULE in 1 BLISTER PACK	2015-11-01

Suppliers for the Pharmaceutical Drug: GENGRAF

Last updated: July 29, 2025

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Introduction

GENGRAF, a formulation of cyclosporine encapsulated in a gel-based vehicle, is primarily utilized in preventing organ transplant rejection and managing autoimmune disorders. As a critical immunosuppressive agent, GENGRAF’s manufacturing and supply chain are tightly regulated to ensure drug efficacy, safety, and consistent availability. This analysis provides an in-depth overview of the principal suppliers involved in the production, formulation, and distribution of GENGRAF, highlighting key players, their roles, and market dynamics.

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Manufacturers of Active Pharmaceutical Ingredient (API): Cyclosporine

At the core of GENGRAF’s composition is cyclosporine, a cyclic peptide immunosuppressant originally derived from the fungus Tolypocladium inflatum. The supply of high-quality cyclosporine API is pivotal, and several pharmaceutical companies globally dominate this segment:

• Novartis AG: Originally developed the drug as Sandimmune, and now supplies the cyclosporine API, though GENGRAF-specific formulations may involve other manufacturers. Novartis's API manufacturing facilities adhere to strict compliance with global standards such as cGMP.

• Sandoz (Novartis division): Produces generic versions of cyclosporine, including APIs that could be used or adapted for formulations like GENGRAF, depending on regional licensing rights.

• Hengli Pharmaceutical: Based in China, Hengli produces bulk cyclosporine API for various formulations, including generic equivalents. They occupy a significant position in the API supply chain, especially in Asia.

• M/S. Zhejiang Hisoar Pharmaceutical Co., Ltd.: A growing Chinese API manufacturer with capabilities in producing cyclosporine, targeting both local and international markets.

• Jeras Pharmaceuticals: Specializes in sourcing and supplying high-quality cyclosporine APIs for various pharmaceutical companies, including both innovator and generic markets.

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Formulation and Packaging Suppliers

GENGRAF's unique gel-based delivery system involves specific excipients and encapsulation technology, requiring specialized formulation and packaging providers:

• Rebelcell Pharmaceutical Technologies: Known for developing proprietary gel-based drug delivery systems suited for immunosuppressants like GENGRAF.

• Capsugel (now part of Lonza): Supplies gel capsules and customized formulations tailored for GENGRAF’s unique delivery mechanism. Their expertise ensures bioavailability and stability.

• Colorcon: Provides high-quality excipients, coatings, and related products integral to GENGRAF’s stability and controlled-release specifications.

• SGS Group: Offers stability and compatibility testing services to verify compatibility between the API and excipients used in GENGRAF formulations.

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Contract Manufacturing Organizations (CMOs)

Manufacturing GENGRAF involves complex encapsulation and stability procedures, often outsourced to specialized CMOs:

• Catalent Inc.: Offers comprehensive development, encapsulation, and fill-finish services with extensive experience in gel-based drug formulations.

• Lonza: Provides drug substance production and formulation services, including gel-based delivery systems aligned with GENGRAF specifications.

• Famar: A prominent European contract manufacturer, equipped to produce complex oral gel formulations, ensuring compliance with regulatory standards.

• Recipharm: Offers formulation development and manufacturing services, including gel encapsulation and fill-finish operations.

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Distribution and Wholesale Suppliers

Ensuring global supply of GENGRAF entails collaboration with authorized distributors and wholesalers:

• McKesson Corporation: Major pharmaceutical distributor with provision of GENGRAF to healthcare providers in North America.

• Cardinal Health: Supplies GENGRAF through its extensive distribution network, focusing on hospital and specialty pharmacy channels.

• Phoenix Group: Specializes in distributing immunosuppressant drugs, including GENGRAF, in diverse markets.

• National Pharmaceutical Wholesalers in Europe and Asia: Local distributors play pivotal roles in ensuring regional availability and regulatory compliance.

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Regulatory and Certification Bodies

Procurement and supply chain integrity depend heavily on compliance with regulatory agencies:

• FDA (U.S. Food and Drug Administration): Certifies manufacturing facilities and enforces quality standards for GENGRAF’s suppliers operating in the U.S.

• EMA (European Medicines Agency): Oversees approval and manufacturing standards for GENGRAF suppliers within the EU.

• PMDA (Pharmaceuticals and Medical Devices Agency, Japan): Ensures compliance for GENGRAF’s regional suppliers in Japan.

• GMP Certification Bodies: Globally recognized agencies such as SGS, TÜV SÜD, and NSF International validate manufacturing quality.

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Market Dynamics and Strategic Sourcing

The supply landscape for GENGRAF is influenced by factors including patent status, regional regulatory approvals, and manufacturing capacity. While the original innovator product was developed by Novartis, generic manufacturing has expanded globally, diversifying supplier options. Patent expirations have increased the number of approved generic suppliers, particularly in Asia, which has increased supply robustness but also necessitates diligent quality verification.

New formulations aiming to improve bioavailability and reduce side effects influence supplier capabilities in advanced drug delivery technologies, favoring partnerships with specialized formulation firms and CMOs adept at encapsulation and controlled-release systems.

Supply chain risks—such as geopolitical tensions, raw material shortages, or regulatory delays—necessitate strategic inventory management and diversified sourcing, particularly from Asian API manufacturers, who have gained prominence in recent years.

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Conclusion

The GENGRAF supply chain encompasses a complex ecosystem of API manufacturers, formulation specialists, CMOs, and distribution channels. Key players such as Novartis, Hengli Pharmaceutical, Lonza, Catalent, and major distribution companies maintain the critical infrastructure to meet global demand. Ensuring drug quality, regulatory compliance, and supply stability remains an ongoing challenge, particularly amidst growing regional manufacturing capabilities and evolving patent landscapes.

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Key Takeaways

• Diverse sourcing is vital: GENGRAF’s supply relies on multiple API producers and formulators worldwide, primarily in North America, Europe, and Asia.

• Regulatory compliance underpins supply chain stability: Facilities and suppliers must meet rigorous GMP standards enforced by agencies like the FDA and EMA.

• Advanced formulation technology providers are key: Specialized firms in gel-based drug delivery systems ensure GENGRAF’s unique performance attributes.

• Regional distributors enhance availability: Established pharmaceutical wholesalers and distributors expand GENGRAF access across global markets, emphasizing the importance of a reliable distribution network.

• Strategic risk management is essential: Diversification of suppliers and inventory safeguards against disruptions caused by geopolitical or manufacturing issues.

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FAQs

1. Who are the primary API suppliers for GENGRAF?
Major API suppliers include Novartis (original developer), Hengli Pharmaceutical, Zhejiang H isoar Pharmaceutical, and Jeras Pharmaceuticals, with Hengli and Zhejiang H isoar being prominent Chinese manufacturers supplying generics.

2. Are there regional differences in GENGRAF’s suppliers?
Yes. In North America and Europe, GENGRAF is primarily supplied through established companies like Novartis and Lonza, whereas Asian markets increasingly source from local manufacturers like Hengli and Zhejiang H isoar, reflecting regional manufacturing capabilities.

3. How does the formulation technology influence supplier selection?
GENGRAF’s gel-based delivery system requires specialized formulation expertise. Suppliers with experience in gel encapsulation and controlled-release technologies are preferred to ensure product stability and consistent bioavailability.

4. What role do regulatory agencies play in GENGRAF’s supply chain?
Regulatory agencies enforce GMP standards, certify manufacturing facilities, and approve suppliers. Their oversight ensures that GENGRAF’s quality and safety meet international standards, maintaining supply chain integrity.

5. What risks threaten GENGRAF’s supply chain, and how are they mitigated?
Risks include raw material shortages, geopolitical disruptions, and manufacturing delays. Mitigation strategies involve sourcing from multiple suppliers, maintaining strategic inventories, and complying with international quality standards.

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References

1. [1] Novartis official website and filings on cyclosporine production.
2. [2] Hengli Pharmaceutical corporate disclosures.
3. [3] Lonza’s formulation services for gel-based drug delivery.
4. [4] Regulatory standards from FDA, EMA, and other agencies.
5. [5] Global pharmaceutical distribution network analyses.