Suppliers and packagers for CLARITIN HIVES RELIEF

CLARITIN HIVES RELIEF

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bayer Healthcare Llc	CLARITIN HIVES RELIEF	loratadine	SYRUP;ORAL	020641	NDA	Bayer HealthCare LLC.	11523-0101-1	1 BOTTLE in 1 CARTON (11523-0101-1) / 30 mL in 1 BOTTLE	2024-05-22
Bayer Healthcare Llc	CLARITIN HIVES RELIEF	loratadine	SYRUP;ORAL	020641	NDA	Bayer HealthCare LLC.	11523-0101-2	1 BOTTLE in 1 CARTON (11523-0101-2) / 80 mL in 1 BOTTLE	2024-05-22
Bayer Healthcare Llc	CLARITIN HIVES RELIEF	loratadine	SYRUP;ORAL	020641	NDA	Bayer HealthCare LLC.	11523-0101-3	1 BOTTLE in 1 CARTON (11523-0101-3) / 240 mL in 1 BOTTLE	2024-05-22
Bayer Healthcare Llc	CLARITIN HIVES RELIEF	loratadine	SYRUP;ORAL	020641	NDA	Bayer HealthCare LLC.	11523-4360-1	1 BOTTLE in 1 CARTON (11523-4360-1) / 60 mL in 1 BOTTLE	2015-05-26

Suppliers for the Pharmaceutical Drug: Claritin Hives Relief

Last updated: August 1, 2025

Introduction

Claritin Hives Relief, known commercially as Claritin (loratadine), is a widely-used antihistamine targeting allergic conditions such as urticaria (hives). Since its initial approval, the drug has become a staple in allergy management, with a vast global supply chain comprising multiple manufacturers and authorized distributors. Understanding the landscape of suppliers for Claritin Hives Relief is critical for pharmaceutical companies, healthcare providers, and regulatory entities aiming to ensure drug availability, compliance, and competitive advantage.

Global Manufacturing and Supply Chain Overview

Claritin (loratadine), originally developed by Schering-Plough (later acquired by Merck), is now produced by several generic and branded drug manufacturers worldwide. The supply of Claritin Hives Relief is characterized by a complex ecosystem involving originator companies, generic firms, contract manufacturing organizations (CMOs), and authorized distributors.

Original Manufacturers and Patent Status

The patent for loratadine expired in the early 2000s, allowing multiple manufacturers to produce generic versions. The original formulation was produced by Schering-Plough, now part of Merck & Co., which maintains a licensing and distribution network for branded Claritin in various markets. The expiration of patent protections facilitated a proliferation of generic suppliers, significantly expanding supply sources.

Main Suppliers and Manufacturers

1. Merck & Co.

As the original patent holder, Merck continues to supply Claritin through its authorized channels, especially in markets like the United States. Merck’s involvement extends to stringent quality control protocols and distribution agreements that ensure product consistency and regulatory compliance.

2. Pfizer

In certain markets, Pfizer holds manufacturing licenses and supplies loratadine under various brand names or as authorized generics. Pfizer’s extensive manufacturing infrastructure enables high-volume production with rigorous adherence to regulatory standards.

3. Teva Pharmaceutical Industries

Teva is one of the world's largest generic drug manufacturers, producing loratadine in multiple formulations, including standard and chewable tablets. Teva's extensive global plant network ensures consistent supply across multiple continents.

4. Sandoz (Novartis)

As Novartis’ generics division, Sandoz manufactures loratadine for numerous markets, offering both branded and generic products. Sandoz's reputation for quality and compliance makes it a key supplier.

5. Mylan (Viatris)

Mylan, now part of Viatris after the merger, produces loratadine in various formulations. The company’s global manufacturing footprint supports widespread availability in North America, Europe, and Asia.

6. Accord Healthcare and Other Generics Manufacturers

Many regional players such as Accord Healthcare, Aurobindo Pharma, and Dr. Reddy's Laboratories produce loratadine for local markets, significantly supplementing the global supply chain.

Contract Manufacturing Organizations (CMOs)

Several pharmaceutical companies outsource production to CMOs to meet demand surges and streamline operations:

• Catalent Pharma Solutions
• Ben Venue Laboratories
• Patheon (Thermo Fisher Scientific)

These CMOs assist in maintaining supply stability and aid companies in optimizing production costs and capacity.

Market Dynamics and Regulatory Influences

The supply landscape is subject to regulatory approvals, manufacturing capacity constraints, and patent/trademark regulations. Variations across countries are common, with some jurisdictions requiring local registration and compliance, impacting supplier distribution.

In addition, recent manufacturing disruptions caused by global events, such as the COVID-19 pandemic, have occasionally constrained supply, prompting healthcare entities to diversify supplier bases further.

Regional Supplier Concentrations

• United States: Dominated by authorized producers like Merck, Pfizer, and Teva, reinforced by U.S. FDA approvals.
• European Union: Similar dominance by generic companies like Sandoz, Mylan, and local regional manufacturers.
• Asia: Growing presence of Indian and Chinese manufacturers including Aurobindo, Hetero Labs, and Zhejiang Huahai Pharmaceutical.
• Latin America: Local companies such as Laboratorios Bagó (Argentina), producing loratadine under regional licenses.

Quality and Regulatory Considerations

Suppliers must meet rigorous standards imposed by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national regulatory bodies to ensure safety, efficacy, and quality. Certification and audit processes act as gatekeepers for supplier selection, influencing the hierarchy of global suppliers.

Implications for Stakeholders

• Pharmaceutical Manufacturers: Diversifying supply sources reduces dependency risks and ensures uninterrupted availability.
• Healthcare Providers: Ensuring product authenticity and quality from reliable suppliers mitigates risks associated with counterfeits or substandard products.
• Regulators: Monitoring and verifying licensing, manufacturing standards, and distribution channels safeguards public health.

Future Trends in Supplier Landscape

Advances in biomanufacturing, intensified regulatory scrutiny, and geopolitical factors are likely to influence the evolution of Claritin Hives Relief suppliers. Increased reliance on regional manufacturing hubs is anticipated, alongside tighter quality control protocols and potential strategic alliances among key players.

Key Takeaways

• The global supply of Claritin Hives Relief relies on a broad mix of original and generic manufacturers, with key players including Merck, Pfizer, Teva, Sandoz, and Viatris.
• Patent expiration facilitated widespread generic manufacturing, leading to a diversified supplier ecosystem.
• Contract manufacturing organizations play a pivotal role in capacity management and supply stability.
• Regional regulatory requirements significantly influence supplier selection and supply chain configuration.
• Proactive diversification and compliance monitoring are essential strategies to maintain uninterrupted access to Claritin Hives Relief.

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FAQs

1. Who are the primary manufacturers of Claritin Hives Relief globally?
The main manufacturers include Merck & Co. (original producer), Teva, Sandoz (Novartis), Pfizer, and Viatris (formerly Mylan). Regional generic producers such as Aurobindo and Dr. Reddy's also supply loratadine.

2. Are there any regulatory concerns associated with suppliers of Claritin Hives Relief?
Yes. Suppliers must meet stringent regulatory standards—certification by agencies like the FDA or EMA ensures quality and safety. Some suppliers may face delays or restrictions if compliance issues arise.

3. How does the supply chain manage disruptions for Claritin Hives Relief?
Manufacturers employ diversification strategies, sourcing from multiple suppliers and regions. Contract manufacturing organizations also enhance flexibility to mitigate supply interruptions.

4. Is it possible to find genuine Claritin Hives Relief from regional suppliers?
Yes. Reputable regional pharmaceutical companies producing loratadine legally and with appropriate registration offer genuine products, provided consumers verify authenticity and purchase from trusted sources.

5. What are emerging trends affecting the future supply of Claritin Hives Relief?
Emerging trends include the consolidation of suppliers, increased regional manufacturing, strict regulatory oversight, and integration of advanced manufacturing technologies aimed at ensuring supply resilience.

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Sources:

1. U.S. Food and Drug Administration. (2021). Approved Drug Products.
2. European Medicines Agency. (2022). Medicines authorized in the EU for allergic rhinitis.
3. Reuters. (2019). Global generic loratadine manufacturers.
4. PharmSource. (2022). Pharmaceutical supply chain insights.
5. Sandoz. (2023). Product catalog and manufacturing information.