Suppliers and packagers for LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOCETIRIZINE DIHYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chartwell Molecular	LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	SOLUTION;ORAL	204599	ANDA	Chartwell RX, LLC	62135-917-38	148 mL in 1 BOTTLE (62135-917-38)	2017-05-15
Padagis Us	LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	SOLUTION;ORAL	091263	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-680-28	148 mL in 1 BOTTLE (45802-680-28)	2011-11-07
Padagis Us	LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	SOLUTION;ORAL	091263	ANDA	Bryant Ranch Prepack	63629-2533-1	1 BOTTLE in 1 CARTON (63629-2533-1) / 148 mL in 1 BOTTLE	2011-11-07

Suppliers for the Pharmaceutical Drug: Levocetirizine Dihydrochloride

Last updated: July 29, 2025

Introduction

Levocetirizine dihydrochloride, a potent antihistamine, is widely utilized for the treatment of allergic rhinitis and chronic idiopathic urticaria. As a third-generation antihistamine, it offers rapid relief with a favorable safety profile. The global demand for this drug necessitates a comprehensive understanding of key suppliers across manufacturing, raw material sourcing, and distribution channels. This report delineates the primary suppliers of levocetirizine dihydrochloride, analyzing their production capacities, geographic distribution, and market positioning to assist stakeholders in strategic sourcing and supply chain management.

Manufacturers of Levocetirizine Dihydrochloride

1. Synthesis and Contract Manufacturing Organizations

A. Zydus Cadila

Zydus Cadila, an Indian pharmaceutical powerhouse, is among the leading producers of levocetirizine dihydrochloride. The company leverages robust R&D capabilities and large-scale manufacturing facilities compliant with global standards (GMP). Zydus supplies both active pharmaceutical ingredients (APIs) and finished products to international markets, particularly in Asia, Europe, and North America (Zydus website).

B. Sandoz (Novartis Group)

Sandoz, a division of Novartis, is a renowned global supplier of generic pharmaceuticals, including levocetirizine dihydrochloride. With manufacturing facilities in Europe and Asia, Sandoz emphasizes high-quality APIs adhering to strict regulatory standards (Sandoz official disclosures). Their capacity for large batches makes them a key supplier for global clients seeking consistent supply.

C. Teva Pharmaceuticals

Teva, headquartered in Israel, ranks among the largest generic drug producers globally. The company's extensive API manufacturing infrastructure includes facilities dedicated to antihistamine compounds, including levocetirizine. Teva’s strategic manufacturing locations in Israel and India enable cost-effective volume production.

D. Mylan (now part of Viatris)

Viatris acquired Mylan, expanding its portfolio and manufacturing footprint. Mylan's facilities produce levocetirizine dihydrochloride primarily in India and Eastern Europe, serving both regional markets and export channels (Viatris corporate reports).

2. Regional and Emerging Market Suppliers

E. Hetero Labs

An Indian API manufacturer with growing export capacity, Hetero Labs supplies levocetirizine dihydrochloride to numerous generic drug makers worldwide. Their focus on quality control and cost efficiency has increased their market share significantly in Asia, Africa, and Latin America.

F. Lek Pharmaceuticals

A Slovene pharmaceutical company, Lek manufactures levocetirizine dihydrochloride and supplies it to European markets. Known for compliance with stringent European regulatory standards, Lek remains a reliable regional supplier (Lek corporate website).

Raw Material Suppliers

Levocetirizine dihydrochloride synthesis depends on high-purity raw materials, including specific p-chlorobenzene derivatives, amino compounds, and hydrochloric acid.

Key Raw Material Suppliers

• Akzonobel and BASF provide essential chemicals used in API synthesis, such as hydrochloric acid and intermediate aromatic compounds.
• SACHEM supplies specialty chemicals required in antihistamine synthesis processes.

Most raw material suppliers operate globally, with manufacturing hubs in Asia and Europe, ensuring supply chain resilience.

Distribution and Logistics Providers

Major pharmaceutical logistics companies, including DHL Supply Chain and DHL Pharma, facilitate the transportation of both APIs and finished products, ensuring adherence to temperature controls and regulatory compliance throughout the supply chain.

Market Dynamics and Supplier Evaluation

The primary criteria influencing supplier selection include regulatory compliance, manufacturing capacity, quality assurance practices, cost competitiveness, and supply chain reliability.

• Regulatory Compliance: Suppliers such as Sandoz, Teva, and Lek adhere to EMA, FDA, and WHO standards, offering peace of mind regarding GMP accreditation.
• Manufacturing Capacity: Zydus, Sandoz, and Teva possess extensive facilities capable of large-volume production, addressing global demand surges.
• Quality Assurance: Leading suppliers maintain rigorous quality management systems, including in-process controls and batch consistency.

The ongoing geopolitical shifts, particularly in India and China, influence supplier choices and risks. Diversification across regions remains crucial to mitigate supply disruptions.

Key Suppliers Summary Table

Supplier	Location	Products	Strengths	Regulatory Compliance
Zydus Cadila	India	API, Finished Formulations	Large capacity, affordability	GMP, WHO, USFDA
Sandoz (Novartis)	Europe/Asia	API	High quality, global presence	EMA, FDA approval
Teva	Israel	API	Extensive capacity, cost-effective	GMP, USFDA
Mylan (Viatris)	India/EU	API	Diversified manufacturing	GMP, EMA
Hetero Labs	India	API	Cost efficiency, export focus	GMP
Lek Pharmaceuticals	Slovenia	API	European standards, reliability	EMA

Conclusion

Securing a reliable supply of levocetirizine dihydrochloride requires engagement with established global and regional suppliers known for regulatory compliance and manufacturing excellence. Leading manufacturers such as Zydus Cadila, Sandoz, and Teva dominate the API production landscape, supported by raw material suppliers located primarily in Asia and Europe. Diversification and thorough due diligence are necessary to mitigate supply chain risks, especially amid geopolitical uncertainties.

Key Takeaways

• The global market for levocetirizine dihydrochloride is dominated by Indian, Israeli, and European manufacturers offering high-volume, GMP-compliant APIs.
• Leading suppliers possess extensive regulatory approvals, ensuring suitability for international markets.
• Quality assurance, regulatory compliance, and supply chain resilience outweigh cost considerations for high-stakes procurement.
• Regional suppliers like Lek Pharmaceuticals strengthen European supply reliability, whereas Asian manufacturers provide cost-effective solutions for emerging markets.
• Strategic sourcing should focus on partnerships with validated suppliers, considering geopolitical and geopolitical risks, to ensure uninterrupted supply.

FAQs

1. Who are the top global suppliers of levocetirizine dihydrochloride?
Major global suppliers include Zydus Cadila (India), Sandoz/Novartis (Europe/Asia), and Teva Pharmaceuticals (Israel), each offering large-scale, GMP-compliant APIs.

2. What are the key factors to consider when selecting a levocetirizine dihydrochloride supplier?
Regulatory compliance, manufacturing capacity, API quality standards, cost-effectiveness, and supply chain reliability are critical.

3. Are Chinese companies involved in the production of levocetirizine dihydrochloride?
While some Chinese API manufacturers are involved, the leading global suppliers are predominantly based in India, Europe, and Israel, with Chinese players playing an increasingly significant role.

4. How does regulatory compliance impact supplier choice?
Regulatory standards like EMA, FDA, and WHO accreditation ensure product quality and marketability; non-compliance risks product recalls and regulatory actions.

5. What are future market trends for levocetirizine dihydrochloride suppliers?
Increasing demand in emerging markets, regulatory harmonization, and supply chain diversification are key trends shaping the supplier landscape.

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Sources:

1. Zydus Cadila Official Website.
2. Sandoz Official Website.
3. Teva Pharmaceuticals Annual Report.
4. Viatris Corporate Reports.
5. Lek Pharmaceuticals Website.