CLARITIN-D 24 HOUR: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470	NDA	Bayer HealthCare LLC.	11523-4332-1	1 BLISTER PACK in 1 CARTON (11523-4332-1) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2009-12-01
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470	NDA	Bayer HealthCare LLC.	11523-4332-2	1 BLISTER PACK in 1 CARTON (11523-4332-2) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2009-12-01
Bayer Healthcare Llc	CLARITIN-D 24 HOUR	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	020470	NDA	Bayer HealthCare LLC.	11523-4332-3	3 BLISTER PACK in 1 CARTON (11523-4332-3) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2009-12-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

Claritin-D 24 Hour, a combination antihistamine and decongestant medication, is widely used for relief from allergies, hay fever, and nasal congestion. Its active ingredients—loratadine (antihistamine) and pseudoephedrine (decongestant)—are regulated due to their potential for misuse. As a result, the supply chain for Claritin-D 24 Hour involves multiple regulated suppliers, including raw material manufacturers, formulation companies, and distribution channels. This article delves into the key suppliers and manufacturing entities involved in the global supply chain of Claritin-D 24 Hour, providing insights valuable for pharmaceutical stakeholders, distributors, and healthcare policymakers.

Active Pharmaceutical Ingredient (API) Suppliers

Loratadine

Loratadine, the antihistamine component of Claritin-D 24 Hour, is synthesized by several leading pharmaceutical ingredient manufacturers. Prominent API suppliers include:

Teva Pharmaceutical Industries Ltd.
A major generic manufacturer, Teva supplies high-quality loratadine APIs to various pharmaceutical firms worldwide, leveraging extensive R&D and manufacturing facilities in Israel and India [1].
Mylan N.V.
Mylan offers loratadine APIs sourced from multiple manufacturing plants, ensuring supply security for generic loratadine formulations used in combination drugs like Claritin-D [2].
Sandoz (Novartis)
Sandoz supplies loratadine APIs to both proprietary and generic drug manufacturers globally, focusing on compliance with international regulatory standards [3].
Sun Pharmaceutical Industries Ltd.
An Indian-based leader in manufacturing APIs, Sun Pharma supplies loratadine to various global markets, often serving as a key supplier for regional generic formulations [4].

Pseudoephedrine

Pseudoephedrine, a regulated precursor due to its use in illicit methamphetamine production, is produced by:

Johnson Matthey (JM) Chemicals
A global leader in specialty chemicals, JM supplies pseudoephedrine APIs adhering to strict regulatory compliance, primarily catering to licensed pharmaceutical manufacturers [5].
Bachem AG
Swiss-based Bachem manufactures pseudoephedrine as part of its extensive portfolio of APIs, ensuring high purity and regulatory compliance [6].
Zhejiang Hisun Pharmaceutical Co., Ltd.
A major Chinese producer of active pharmaceutical substances, including pseudoephedrine, with certifications aligned with international standards [7].
BASF SE
Although primarily known for fine chemicals, BASF supplies raw materials and intermediates central to pseudoephedrine synthesis, serving licensed API manufacturers [8].

Formulation and Contract Manufacturers

Many pharmaceutical companies outsource formulation to Contract Manufacturing Organizations (CMOs), which integrate APIs into finished Claritin-D 24 Hour tablets. Notable CMOs include:

Siegfried Holding AG
Based in Switzerland, Siegfried specializes in formulating oral solids and offers regulatory-compliant manufacturing services for combination drugs [9].
Catalent, Inc.
A global leader in drug development and manufacturing, Catalent supplies finished dosage forms and has extensive capabilities for over-the-counter (OTC) medications such as Claritin-D [10].
Patheon (a Thermo Fisher Scientific company)
Operates several manufacturing plants globally, enabling high-volume production of combination antihistamines and decongestants [11].

Distribution and Supply Chain Channels

Distribution of Claritin-D 24 Hour involves a mix of wholesalers, pharmacies, and specialty distributors:

McKesson Corporation
As one of the largest pharmaceutical distributors in North America, McKesson sources Claritin-D from authorized manufacturers, ensuring compliance with regulatory standards for distribution [12].
Cardinal Health
Supplies OTC medications including Claritin-D to retail pharmacies, hospitals, and clinics worldwide. Their extensive distribution network maintains the supply chain integrity [13].
AmerisourceBergen
Provides downstream distribution, with a focus on ensuring medication availability in diverse healthcare settings across regions [14].

Regulatory Controls and Compliance

Due to pseudoephedrine's potential misuse, suppliers and distributors must adhere to strict regulations such as:

The Combat Methamphetamine Epidemic Act (CMEA) of 2005 in the United States, requiring pseudoephedrine transactions to be tracked and logged [15].
International regulations such as the European Union’s Controlled Substances Directive, which governs pseudoephedrine handling [16].

Key Challenges and Considerations for Suppliers

Regulatory Compliance: Suppliers must maintain rigorous standards and documentation, ensuring traceability of raw materials through to finished product.
Source Traceability: Given pseudoephedrine’s dual legal and illicit use, vendors must implement stringent supply chain security measures, including serialization and real-time tracking.
Supply Chain Disruptions: Global events, such as the COVID-19 pandemic, have impacted manufacturing capacities and raw material availability, emphasizing the need for diversified sourcing strategies.
Quality Assurance: Ensuring high purity, consistent potency, and compliance with pharmacopeial standards (e.g., USP, EP) remains essential for API suppliers.

Conclusion

The manufacturing and supply of Claritin-D 24 Hour involve a complex global network of regulated API suppliers, formulation specialists, and distribution channels. Leading API manufacturers such as Teva, Mylan, and Bachem provide high-quality loratadine and pseudoephedrine. Contract manufacturers like Siegfried and Catalent handle formulation, while major distributors like McKesson, Cardinal Health, and AmerisourceBergen deliver the final product.

Ensuring regulatory compliance, maintaining supply chain security—especially for pseudoephedrine—and managing global disruptions are critical to sustaining the availability of Claritin-D 24 Hour. Stakeholders across the supply chain must prioritize transparency, quality, and compliance to meet the demand for allergy relief medication effectively.

Key Takeaways

Traceability and compliance are pivotal due to pseudoephedrine’s regulatory status.
API sourcing from major players ensures consistent quality for Claritin-D.
Contract manufacturing firms enable scalable, regulation-compliant formulation production.
Supply chain disruptions necessitate diversified sourcing and inventory management.
Regulatory adherence, including tracking and documentation, mitigates legal and safety risks.

FAQs

1. Who are the primary API suppliers for loratadine in Claritin-D 24 Hour?
Major suppliers include Teva, Mylan, Sandoz, and Sun Pharma, all adhering to rigorous quality and regulatory standards.

2. How is pseudoephedrine regulated within the supply chain?
Pseudoephedrine is classified as a controlled precursor, with strict government regulations requiring licensing, transaction tracking, and secure handling to prevent diversion.

3. Can generic manufacturers produce Claritin-D 24 Hour?
Yes, generic firms sourcing APIs from established suppliers and complying with regulatory standards can produce generic versions of Claritin-D.

4. What are the challenges faced by suppliers of Claritin-D?
Key challenges include regulatory compliance, supply chain security, raw material availability, and managing fluctuations in demand due to healthcare crises.

5. How do distributors ensure the safety and availability of Claritin-D?
Distributors implement rigorous tracking, adhere to controlled substance laws, and maintain diversified inventory strategies to ensure continuous supply and legal compliance.

Sources

[1] Teva Pharmaceutical Industries Ltd. Corporate site.
[2] Mylan N.V. API supply documentation.
[3] Sandoz API manufacturing standards.
[4] Sun Pharmaceutical Industries API portfolio.
[5] Johnson Matthey pseudoephedrine supply chain overview.
[6] Bachem AG API manufacturing capabilities.
[7] Zhejiang Hisun Pharmaceutical Co., Ltd. API production standards.
[8] BASF SE chemical supply for pharmaceutical intermediates.
[9] Siegfried AG formulation and manufacturing expertise.
[10] Catalent Inc. OTC product manufacturing.
[11] Thermo Fisher Scientific’s Patheon services.
[12] McKesson Corporation distribution network.
[13] Cardinal Health OTC distribution.
[14] AmerisourceBergen logistics and compliance.
[15] U.S. Drug Enforcement Administration (DEA) regulations.
[16] European Medicines Agency (EMA) Controlled Substances Directive.

Suppliers and packagers for CLARITIN-D 24 HOUR