Suppliers and packagers for claritin

claritin

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	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	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	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

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: Claritin

Introduction
Claritin, the brand name for loratadine, is a widely used antihistamine primarily indicated for allergy relief, including hay fever and urticaria. Since its initial approval in the late 1990s, Claritin has become a cornerstone in over-the-counter allergy medication. The manufacturing and distribution of Claritin involve a complex network of suppliers spanning raw material producers, active pharmaceutical ingredient (API) manufacturers, formulation specialists, and distribution partners. This article delineates the key suppliers involved in the Claritin supply chain, providing insights into their roles and strategic significance.

1. Raw Material Suppliers
The foundation of Claritin production lies in sourcing high-quality raw materials. The critical raw materials include chemical precursors necessary for synthesizing loratadine. Suppliers in this category are typically specialized chemical manufacturers with capabilities to produce pharmaceutical-grade intermediates.

• Chemical Intermediate Suppliers
  Several chemical companies supply the raw precursors needed for loratadine synthesis. Among these, global chemical giants such as Sigma-Aldrich (part of Merck KGaA) and Thermo Fisher Scientific play crucial roles, providing reagents like 4-Chlorobenzotrifluoride, which is essential in the synthesis pathway.

• Precursors and Building Blocks
  Specialized API manufacturers may source intermediates like 2-Chlorobenzyl chloride and piperidine derivatives from regional chemical producers, often based in East Asia, India, or Europe, where chemical manufacturing is highly developed.

2. Active Pharmaceutical Ingredient (API) Manufacturers
The core of Claritin’s production process involves the synthesis of loratadine, which is then formulated into tablets or other dosage forms.

• Major API Producers
  Leading pharmaceutical API manufacturers, such as Teva Pharmaceuticals, Mylan (now part of Viatris), Sandoz, and Dr. Reddy’s Laboratories, have historically been involved in large-scale loratadine production. These companies possess the manufacturing capacity, quality control systems, and regulatory approvals necessary to supply the global market.

• Contract Manufacturing Organizations (CMOs)
  Many brand owners outsource API production to CMOs with specialized capabilities. Companies like Hetero Labs and Aurobindo Pharma have expanded their API manufacturing capacity for loratadine to meet global demand, especially in response to the drug becoming available OTC in multiple countries.

• Geographical Distribution
  API manufacturing is predominantly concentrated in India, China, and Europe, reflecting regional centers of pharmaceutical production efficiency. Supply chain resilience depends on sourcing from multiple geographically dispersed API producers to mitigate geopolitical or pandemic-related disruptions.

3. Formulation and Excipients Suppliers
Beyond APIs, formulation involves excipients—inactive substances that facilitate drug delivery and stability.

• Excipients Suppliers
  Companies like JRS Pharma, Lubrizol, and Megafine supply fillers, binders, disintegrants, and preservatives used in Claritin tablets. These companies adhere to strict pharmaceutical standards to ensure excipient safety and efficacy.

• Packaging Suppliers
  Packaging material suppliers such as Amcor and Berry Global provide blister packs, bottles, and labeling required to comply with regulatory and aesthetic standards.

4. Finished Product Manufacturing and Assembly
Once the API and excipients are procured, finished product manufacturers handle blending, tablet compression, coating, and packaging.

• Major Contract Manufacturers
  Large pharmaceutical companies such as Glenmark, AstraZeneca, and regional manufacturers in India and Eastern Europe produce final Claritin formulations under license or as OEM (original equipment manufacturer).

• Regulatory Compliance
  These manufacturers must meet Good Manufacturing Practice (GMP) standards, and many operate under stringent certifications from agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or local regulatory bodies.

5. Distribution Channels and Logistics
Distribution is managed via a complex network of wholesalers, pharmacies, and international logistics providers.

• Global Distribution Firms
  Providers such as McKesson, AmerisourceBergen, and Cardinal Health facilitate the movement of Claritin products worldwide, ensuring availability in diverse markets.

• Regional Distributors and Retailers
  The drug reaches consumers through regional pharmacy chains, online aggregators, and healthcare providers, emphasizing the importance of supply chain agility amidst pandemic challenges and regulatory variations.

6. Patent and Licensing Landscape
Though loratadine’s patent expired in the early 2000s, many generic versions are produced by multiple manufacturers, resulting in an extensive supplier network. Some companies hold exclusive licenses for certain formulations or markets, which shapes the supply landscape.

7. Strategic Considerations
The supply chain for Claritin is vulnerable to disruptions due to geopolitical conflicts, trade restrictions, and raw material shortages. Companies often diversify suppliers across regions to mitigate such risks. Additionally, sustainable sourcing and compliance with environmental standards are increasingly prioritized.

Conclusion
The supply chain for Claritin involves a multi-tiered network of raw material suppliers, API manufacturers, formulation companies, and logisticians operating within stringent regulatory frameworks. The global nature of these suppliers allows for price competition and supply resilience, but also necessitates vigilant supply chain management amid geopolitical and economic challenges.

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Key Takeaways

• Claritin’s supply chain depends on numerous specialized suppliers for raw materials, APIs, excipients, and packaging.
• Major API manufacturers include Teva, Mylan (Viatris), and regional players like Hetero and Aurobindo.
• Geographic concentration in India, China, and Europe offers both opportunities for cost efficiencies and risks related to geopolitical disruptions.
• Contract manufacturers streamline final drug production, ensuring conformity to GMP standards.
• Diversification and supply chain resilience are critical in maintaining consistent Claritin availability globally.

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FAQs

Q1: Who are the primary API suppliers for loratadine?
A1: Leading API producers include Teva Pharmaceuticals, Mylan (Viatris), Sandoz, and regional manufacturers like Hetero Labs and Aurobindo Pharma, primarily based in India and China.

Q2: How does supply chain diversity impact Claritin's market availability?
A2: Diversifying suppliers across regions reduces risks of shortages due to geopolitical issues, trade restrictions, or manufacturing disruptions, thus ensuring consistent market supply.

Q3: Are there any notable patent restrictions affecting Claritin's suppliers?
A3: Since loratadine’s patent expired in the early 2000s, multiple generic manufacturers globally produce the drug, expanding the supplier network and increasing market competition.

Q4: What role do contract manufacturing organizations (CMOs) play in Claritin production?
A4: CMOs handle formulation, tablet compression, coating, and packaging, enabling brand owners to scale production efficiently while maintaining quality standards.

Q5: How are excipients and raw materials sourced for Claritin?
A5: Suppliers such as JRS Pharma, Lubrizol, and Megafine provide pharmaceutical-grade excipients, with raw materials sourced from specialized chemical producers globally, particularly in Asia and Europe.

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References

1. Pharmacore, "Loratadine API Suppliers," 2022.
2. U.S. FDA, "Approved Drug Products with Therapeutic Equivalence Evaluations," 2023.
3. MarketWatch, "Global API Market," 2022.
4. IQVIA, "Global Pharmaceutical Supply Chains," 2023.
5. Statista, "Pharmaceutical Packaging Industry Data," 2022.