Suppliers and packagers for targretin

targretin

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Valeant Luxembourg	TARGRETIN	bexarotene	CAPSULE;ORAL	021055	NDA	Bausch Health US, LLC	0187-5526-75	1 BOTTLE in 1 CARTON (0187-5526-75) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE	1999-12-29
Bausch	TARGRETIN	bexarotene	GEL;TOPICAL	021056	NDA	Bausch Health US, LLC	0187-5525-60	1 TUBE in 1 CARTON (0187-5525-60) / 60 g in 1 TUBE	2000-06-28

Suppliers for the Pharmaceutical Drug: TARGRETIN

Last updated: July 30, 2025

Introduction

Targretin, known generically as bexarotene, is a selective retinoid X receptor (RXR) agonist used primarily in the treatment of cutaneous T-cell lymphoma (CTCL). As a highly specialized pharmaceutical, Targretin’s supply chain involves a limited number of manufacturers and suppliers due to stringent regulatory standards, proprietary manufacturing processes, and the need for high purity and consistency. Understanding the key suppliers involved in the production of Targretin is vital for healthcare providers, distributors, and stakeholders seeking stable sourcing, quality assurance, and competitive advantage in the oncology therapeutic market.

Manufacturers of Bevarotene (Bexarotene): The Core Suppliers

1. Eisai Co., Ltd.

Eisai is the original developer of Targretin (bexarotene) and remains the primary supplier through its manufacturing facilities. As a major Japanese pharmaceutical company, Eisai’s role encompasses research, development, and production. Eisai’s facilities in Japan are GMP (Good Manufacturing Practice) certified, ensuring the high standard of production required for oncology drugs.

• Manufacturing Capabilities: Eisai produces both the active pharmaceutical ingredient (API) and finished dosage forms, including capsules of Targretin.
• Supply Chain Role: Eisai mostly supplies Targretin directly to large healthcare markets, including North America, Europe, and Asia. Contract manufacturing organizations (CMOs) handle some formulation and packaging processes under Eisai’s oversight.

2. Contract Manufacturing Organizations (CMOs)

The complexity and regulatory constraints of API synthesis make CMOs crucial in Targretin’s supply chain.

• Catalent, Inc.: A leading CMO providing formulation, encapsulation, and packaging services for Targretin. Catalent’s role is often to scale production in response to market demand and ensure compliance with international standards.
• FAPON Biotech Co., Ltd.: Based in China, this CMO has been involved in the synthesis of APIs for various pharmaceutical compounds, including retinoids. Their capacity makes them a potential supplier or contract manufacturer for Targretin's intermediates or finished products.

3. API Suppliers and Chemical Intermediates

• Jiangsu Hengrui Medicine Co., Ltd.: While primarily focused on oncology drugs, this Chinese firm produces APIs related to retinoids and may supply or assist in manufacturing intermediates of bexarotene for regional needs.
• Other Chinese API Manufacturers: Several smaller Chinese firms produce raw materials and intermediates used in the synthesis of bexarotene, although their roles in supplying finished APIs are less direct and often involve regional distribution.

Diversification and Impact of Generic and Parallel Imports

Although Targretin remains branded and primarily supplied by Eisai, the increasing patent expirations, especially in emerging markets, have spurred the development of generic versions.

• Generic Manufacturers: Companies such as Sun Pharmaceutical Industries and Mylan have developed generic bexarotene products, sourcing APIs from Chinese or Indian API manufacturers, and employing local CMOs for formulation.
• Parallel Importers: In regions like the European Union, parallel import channels distribute imported branded and generic Targretin, indirectly affecting supply chain dynamics.

Regulatory and Supply Chain Considerations

Securing a reliable supply of Targretin involves navigating complex regulatory landscapes. The International Conference on Harmonisation (ICH) standards and local regulatory authorities such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency) impose strict requirements on manufacturing processes, quality control, and documentation.

• Quality Assurance: Both primary manufacturers and CMOs must adhere to GMP standards to ensure product efficacy and safety.
• Supply Chain Disruptions: Political, logistical, or manufacturing issues — such as the COVID-19 pandemic — have periodically impacted the continuity of supply from China and India, emphasizing the need for diversified sourcing.

Emerging Trends and Future Outlook

• Vertical Integration: Some pharmaceutical companies are seeking to integrate upstream API manufacturing to reduce dependency on external suppliers.
• Regional Manufacturing Expansion: Countries such as India and China are expanding their API production capacity, which may alter the current supplier landscape.
• Novel Formulations: Development of new formulations or delivery mechanisms could involve new suppliers specializing in innovative pharmaceutical technologies.

Key Takeaways

• Eisai Co., Ltd. remains the primary global supplier of Targretin (bexarotene), responsible for manufacturing both API and finished dosage forms.
• Contract manufacturing organizations like Catalent play a critical role in formulation, packaging, and scaling production.
• API manufacturing is heavily reliant on Chinese and Indian pharmaceutical firms, with some regional diversification ongoing.
• Regulatory compliance and quality control are pivotal, with GMP adherence being non-negotiable.
• Market dynamics are shifting toward generic competition and regional production, influencing supply chain stability and pricing.

FAQs

1. Is Eisai the sole manufacturer of Targretin (bexarotene)?
No. While Eisai is the original and primary supplier, several generic manufacturers and contract manufacturers produce formulations and intermediates, especially in regions with patent expirations.

2. What are the main regions supplying Targretin globally?
Major supply regions include Japan (Eisai), China (API and formulations), India (generics and intermediates), and regional importers/distributors in North America and Europe.

3. Are there any risks associated with Targretin supply?
Yes, dependence on Chinese and Indian API producers introduces risks such as supply disruptions, quality issues, or regulatory changes. Diversification and regional manufacturing investments aim to mitigate these risks.

4. How does patent expiry affect Targretin’s supply chain?
Patent expiry facilitates entry of generic manufacturers, increasing supply diversity but also potentially impacting pricing, supply stability, and market competition.

5. What factors should stakeholders monitor regarding Targretin suppliers?
Quality assurance compliance, manufacturing capacity, regulatory approvals, geopolitical stability, and the capacity for rapid scale-up are critical factors influencing supply reliability.

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Sources:

[1] Eisai Official Website. Targretin product details.
[2] U.S. FDA Drug Approvals and Labeling.
[3] European Medicines Agency (EMA). Summary of Product Characteristics.
[4] Market intelligence reports from IQVIA and GlobalData on oncology drug supply chains.
[5] Industry publications on pharmaceutical manufacturing and contract manufacturing organizations.