Suppliers and packagers for CLARITIN-D

CLARITIN-D

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-D	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	019670	NDA	Bayer HealthCare LLC.	11523-7162-1	1 BLISTER PACK in 1 CARTON (11523-7162-1) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2009-12-01
Bayer Healthcare Llc	CLARITIN-D	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	019670	NDA	Bayer HealthCare LLC.	11523-7162-2	2 BLISTER PACK in 1 CARTON (11523-7162-2) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2009-12-01
Bayer Healthcare Llc	CLARITIN-D	loratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	019670	NDA	Bayer HealthCare LLC.	11523-7162-3	3 BLISTER PACK in 1 CARTON (11523-7162-3) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK	2009-12-01

Suppliers for the Pharmaceutical Drug: Claritin-D

Last updated: July 28, 2025

Introduction

Claritin-D, a combination medication consisting of loratadine (an antihistamine) and pseudoephedrine (a decongestant), is widely used to treat allergy symptoms and nasal congestion. Its formulation and manufacturing involve several key suppliers across different components, including active pharmaceutical ingredients (APIs), excipients, and packaging materials. Understanding the global supply landscape for Claritin-D is essential for pharmaceutical companies, healthcare providers, and regulatory bodies to ensure consistent quality, supply chain resilience, and compliance with regulatory standards.

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Active Pharmaceutical Ingredient (API) Suppliers

The core of Claritin-D’s efficacy lies in its APIs—loratadine and pseudoephedrine. Securing reliable sources for these APIs is crucial given their production complexity, regulatory scrutiny, and the impact of geopolitical factors.

Loratadine Suppliers

Loratadine, the antihistamine component, is synthesized through complex organic processes requiring high purity standards.

• Teva Pharmaceuticals: One of the prominent global API suppliers, Teva supplies loratadine to various generic and branded medication manufacturers. Their facilities adhere to Good Manufacturing Practice (GMP) standards and serve markets worldwide.

• Mylan (now part of Viatris): As a significant producer of antihistamine APIs, Mylan supplies loratadine to multiple markets, maintaining stringent quality controls.

• SynthesizeChem (hypothetical): Smaller biotech firms and chemical synthesis companies in India, China, and Europe contribute to the loratadine supply chain, often supplying APIs to larger manufacturers under licensing agreements.

Pseudoephedrine Suppliers

Pseudoephedrine is classified as a controlled precursor due to its use in illicit drug synthesis, making its supply chain tightly regulated.

• Aspen Pharmacare: An established supplier of pseudoephedrine, Aspin provides APIs to licensed manufacturers, complying with international controls like the Chemical Abstracts Service (CAS) regulations.

• Hubei Yake Pharmaceutical Co. (China): A prominent supplier in Asia, they produce pseudoephedrine under strict regulatory oversight, serving both domestic and international clients.

• EPRO Group: An American-based distributor of pharmaceutical precursors, they source pseudoephedrine from licensed producers and supply to authorized pharmaceutical manufacturers.

Regulatory and Supply Chain Considerations

Due to the controlled status of pseudoephedrine, suppliers must comply with strict regulations like the Combat Methamphetamine Epidemic Act (CMEA) in the United States and equivalent international standards. This compliance impacts supply chain flexibility and availability, especially during legislative changes or increased demand.

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Excipients and Inactive Ingredients

Beyond APIs, Claritin-D’s formulation includes excipients such as fillers, binders, and stabilizers, sourced globally:

• Lactose Monohydrate: Suppliers include Meggle and Meggle AG, offering pharmaceutical-grade lactose.

• Microcrystalline Cellulose: Suppliers like FMC Corporation produce high-purity cellulose used as binders or fillers.

• Croscarmellose Sodium: Ingredion and FMC manufacture this super-disintegrant to enhance tablet dissolution.

• Magnesium Stearate: Widely supplied by Avebe and other excipient producers, essential as a lubricant.

Supply of these excipients generally involves stable, large-volume agreements with established chemical and pharmaceutical excipient manufacturers.

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Packaging Material Suppliers

Packaging integrity is critical to maintaining drug efficacy and safety.

• Blister Packaging: Companies like Constantia Flexibles and Amcor Supply the foil and thermoformed packs used for Claritin-D.

• Amber Glass Bottles and Caps: Supplier networks include Schott AG and Gerresheimer, providing sterilized, pharmaceutical-grade containers.

• Desiccants and Sealants: Companies such as Multisorb Technologies supply moisture-absorbing agents and adhesives for packaging.

The pharmaceutical industry’s stringent regulatory environment mandates validated packaging suppliers meeting cGMP requirements.

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Key Supply Chain Challenges

• Regulatory Constraints: Pseudoephedrine's regulatory oversight leads to periodic shortages or delays in procurement.

• Geopolitical Risks: Political tensions or export restrictions can affect API availability, especially from China or India, significant API manufacturing hubs.

• Supply Chain Disruptions: COVID-19 pandemic underscored vulnerabilities in global manufacturing and logistics, impacting API and excipient availability.

• Quality Assurance: Suppliers must demonstrate compliance with regulatory standards like FDA, EMA, and ISO certifications to ensure pharmaceutical-grade products.

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Global and Regional Suppliers

While large multinational corporations dominate API and excipient supplies, regional suppliers also play crucial roles, especially in emerging markets.

• United States and Europe: Concentrate API manufacturing, with strict regulatory environments driving supplier quality standards.

• Asia (China, India): Account for significant API production capacity due to cost advantages, though facing increased regulatory scrutiny and quality assurance challenges.

• South Africa and Latin America: More regional suppliers exist but often with less capacity, emphasizing the importance of diversified supply chains for global manufacturers.

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Implications for Stakeholders

For pharmaceutical companies producing Claritin-D, establishing reliable supply chains involves:

• Supplier Qualification: Conducting rigorous audits and qualification processes for APIs, excipients, and packaging suppliers.

• Diversification: Avoiding reliance on single sources, especially for pseudoephedrine due to regulatory controls.

• Regulatory Compliance: Ensuring all suppliers adhere to cGMP, WHO-GMP, or equivalent standards.

• Supply Chain Monitoring: Implementing real-time supply chain tracking to respond swiftly to disruptions.

Healthcare providers and regulators, in turn, should monitor supply levels to prevent shortages and ensure consistent patient access.

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Conclusion

The supply chain for Claritin-D hinges on a complex network of global API, excipient, and packaging material providers. While dominant players like Teva, Mylan, and regional manufacturers supply the core ingredients, geopolitical, regulatory, and market dynamics continually reshape the landscape. Ensuring an uninterrupted, quality-assured supply requires vigilant supplier qualification, diversified sourcing strategies, and compliance with international standards.

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Key Takeaways

• The core ingredients of Claritin-D—loratadine and pseudoephedrine—are supplied by a combination of multinational firms and regional manufacturers, with pseudoephedrine heavily regulated due to its potential misuse.

• Reliable supply hinges on strict regulatory compliance, transparent sourcing, and diversification across geographically dispersed suppliers.

• Excipient and packaging material suppliers maintain stability through long-term contracts, adherence to quality standards, and capacity to meet high-volume demands.

• Supply chain disruptions, regulatory changes, and geopolitical tensions pose ongoing risks; proactive management is essential for ensuring consistent product availability.

• For stakeholders, understanding the sourcing and regulatory landscape aids in making informed strategic procurement, risk mitigation, and compliance decisions.

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FAQs

1. Who are the leading API manufacturers for loratadine?
Teva Pharmaceuticals and Mylan (now Viatris) are among the primary global suppliers of loratadine APIs, meeting stringent quality standards for pharmaceutical manufacturing worldwide [1].

2. How is pseudoephedrine regulated to prevent misuse?
Pseudoephedrine supply is controlled under laws like the US Combat Methamphetamine Epidemic Act, requiring tracking, licensing, and restrictions on purchase quantities to mitigate illicit drug manufacturing [2].

3. Are there regional suppliers for Claritin-D components?
Yes. Asian companies like Hubei Yake Pharmaceutical and regional excipient producers supply parts of the supply chain, though global supply generally relies on larger, regulated manufacturers.

4. What risks exist in the Claritin-D supply chain?
Risks include API shortages due to regulation, geopolitical tensions affecting production or exports, logistical disruptions, and quality assurance failures.

5. How can pharmaceutical companies mitigate supply chain risks?
By diversifying suppliers, establishing strong regulatory compliance frameworks, conducting rigorous audits, and developing contingency plans for potential disruptions.

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References

[1] U.S. Food and Drug Administration. (2022). API Suppliers Registration Records.

[2] U.S. Drug Enforcement Agency. (2021). Pseudoephedrine regulations and compliance guidelines.