Suppliers and packagers for clarinex

clarinex

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Organon	CLARINEX	desloratadine	TABLET;ORAL	021165	NDA	Organon LLC	78206-119-01	100 TABLET, FILM COATED in 1 BOTTLE (78206-119-01)	2021-06-01
Organon	CLARINEX	desloratadine	TABLET;ORAL	021165	NDA	Organon LLC	78206-188-01	100 TABLET, FILM COATED in 1 BOTTLE (78206-188-01)	2022-08-23

Suppliers for the Pharmaceutical Drug: Clarinex (Desloratadine)

Last updated: July 30, 2025

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Introduction

Clarinex, with the generic name desloratadine, is a non-sedating antihistamine widely prescribed for allergic rhinitis and chronic hives. Since its approval, it has become an essential product in allergy management, with a robust supply chain involving multiple manufacturers and suppliers globally. Understanding the landscape of Clarinex suppliers provides critical insights for stakeholders, including healthcare providers, distributors, and pharmaceutical companies seeking sourcing options or competitive intelligence.

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Manufacturers and Primary Suppliers of Clarinex (Desloratadine)

1. Ajinomoto Pharmaceuticals Co., Ltd.

Overview:
Ajinomoto is a leading Japanese pharmaceutical company and the original developer of desloratadine. Authorized by the original patent holders, Ajinomoto manufactures the active pharmaceutical ingredient (API) and finished dosage forms of Clarinex. Ajinomoto's production facilities in Japan and globally comply with stringent regulatory standards, ensuring high-quality API supply.

Supply Role:
Ajinomoto primarily supplies the desloratadine API for global markets, licensing it to a network of verified pharmaceutical manufacturers and distributors.

Market presence:
In several regions, Ajinomoto licenses local firms. For example, in Japan, Ajinomoto is the sole API supplier, while in other markets, licensing agreements allow multiple entities to manufacture and distribute Clarinex formulations.

2. Mylan (now part of Viatris)

Overview:
Mylan, a global pharmaceutical giant, licensed desloratadine from Ajinomoto and has been a major producer of the Clarinex brand as well as generic versions.

Supply Role:
Mylan produces both API and finished formulations for various markets, especially in North America and Europe. Mylan's vertical integration and extensive manufacturing network enable consistent supply and cost efficiency.

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Generic Manufacturers and API Suppliers

The patent exclusivity for Clarinex expired in various jurisdictions during the late 2010s, leading to emergence of generic manufacturers sourcing API either directly from Ajinomoto or through secondary suppliers.

3. Teva Pharmaceutical Industries

Overview:
Teva is one of the largest generic drug manufacturers globally. It sources API from multiple suppliers, including Ajinomoto for desloratadine, and develops its own formulations.

Supply Role:
Teva produces generic desloratadine tablets for numerous markets, maintaining supply chains that meet FDA and EMA standards, leveraging multiple API sources to mitigate risk.

4. Sandoz (Novartis)

Overview:
Sandoz, the generics division of Novartis, offers desloratadine products and has established sourcing channels for API procurement.

Supply Role:
Maintains diversified API sources and produces formulations meeting global regulatory standards for its generic Clarinex equivalents.

5. Local and Regional API Producers

In addition to multinational corporations, several regional API manufacturers serve specific markets:

• Granules India Ltd. (India): Provides desloratadine API to generic manufacturers.
• Zhejiang Huahai Pharmaceutical Co., Ltd. (China): Known for high-volume API synthesis, including antihistamines.
• Hetero Labs (India): Supplies desloratadine API for local and export markets.

Supply Portfolio and Market Dynamics

• The supply of desloratadine API remains relatively concentrated, with Ajinomoto as the primary original producer.
• Generic manufacturers rely on Ajinomoto's API either through licensed agreements or secondary API suppliers.
• The expansion of regional API facilities in India, China, and other Asia-Pacific markets has diversified the supply chain but remains susceptible to regional regulatory variances and quality standards.
• The expiration of patents has increased competition, leading to more generic options with varying API sources, thereby influencing pricing and supply stability.

Regulatory Considerations

Supply chains are heavily influenced by the regulatory approval processes in different jurisdictions:

• API manufacturers must comply with good manufacturing practices (GMP) and obtain approvals from agencies such as the FDA, EMA, and corresponding local authorities.
• In case of supply disruptions, regulatory agencies may restrict the import/export of active ingredients, affecting global availability.

Supply Chain Risks and Opportunities

Risks:

• Concentration risk: Dependence on Ajinomoto as a sole original API supplier can lead to supply bottlenecks.
• Regional regulatory barriers: Varied standards and tariffs may complicate API sourcing.
• Supply disruptions: Natural disasters, political instability, or global health crises (e.g., COVID-19) can impact manufacturing and distribution.

Opportunities:

• Diversification of API sources with regional manufacturers.
• Vertical integration strategies for pharmaceutical companies seeking supply security.
• Strategic stockpiling or long-term contracts to mitigate shortages.

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Key Takeaways

• Ajinomoto remains the primary original supplier of desloratadine API for Clarinex, with exclusive rights in certain regions.
• Generic manufacturers such as Mylan, Teva, and Sandoz dominate production of finished formulations, sourcing API from multiple suppliers for cost and supply assurance.
• Regional API producers in India and China have expanded supply options, contributing to a dynamically evolving global supply chain.
• Market dynamics are shaped by patent expirations, regulatory standards, and regional manufacturing capabilities, affecting prices and availability.
• Ensuring supply chain resilience involves diversification, strategic long-term partnerships, and adherence to quality and regulatory standards.

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FAQs

1. Who are the main API suppliers for Clarinex (desloratadine)?
The primary original API supplier is Ajinomoto Pharmaceuticals. Generic manufacturers, including Teva, Mylan, and Sandoz, source the API from Ajinomoto or regional API producers like Granules India and Zhejiang Huahai Pharmaceutical.

2. Are there regional differences in Clarinex suppliers?
Yes. In Japan, Ajinomoto is the exclusive API supplier. In North America and Europe, multiple generic manufacturers source API globally, with regional API producers supplementing supply.

3. Has patent expiration increased the number of Clarinex suppliers?
Yes. Patent expirations led to increased generic manufacturing, prompting diversification of API sources and new regional manufacturers.

4. What are the key risks related to Clarinex supply chains?
Concentration of API supply, regional regulatory barriers, geopolitical factors, and manufacturing disruptions are key risks that could impact availability.

5. How can pharmaceutical companies ensure steady Clarinex supply?
By diversifying API sources, establishing long-term contracts with multiple suppliers, and adhering to strong quality assurance protocols to prevent supply disruptions.

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References

[1] Ajinomoto Pharmaceuticals official website.
[2] Mylan corporate disclosures.
[3] Teva Pharmaceuticals product portfolio.
[4] Sandoz API sourcing information.
[5] Industry reports on generic antihistamines market.