Suppliers and packagers for loratadine

loratadine

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma	LORATADINE	loratadine	CAPSULE;ORAL	211900	ANDA	Aurohealth LLC	58602-818-05	5 BLISTER PACK in 1 CARTON (58602-818-05) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	2023-03-24
Aurobindo Pharma	LORATADINE	loratadine	CAPSULE;ORAL	211900	ANDA	Aurohealth LLC	58602-818-08	4 BLISTER PACK in 1 CARTON (58602-818-08) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	2023-03-24
Aurobindo Pharma	LORATADINE	loratadine	CAPSULE;ORAL	211900	ANDA	Aurohealth LLC	58602-818-67	2 BLISTER PACK in 1 CARTON (58602-818-67) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	2023-03-24
Aurobindo Pharma	LORATADINE	loratadine	CAPSULE;ORAL	211900	ANDA	Aurohealth LLC	58602-818-83	1 BLISTER PACK in 1 CARTON (58602-818-83) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	2023-03-24

Suppliers for the Pharmaceutical Drug: Loratadine

Last updated: July 28, 2025

Introduction

Loratadine is a widely used second-generation antihistamine prescribed primarily for allergic rhinitis, hay fever, and urticaria. Known for its non-sedative profile, loratadine has become a staple in allergy management worldwide. The global demand for loratadine has led to a complex supply chain involving active pharmaceutical ingredient (API) manufacturers, formulation developers, and distributors. Understanding the landscape of loratadine suppliers offers insights into market stability, quality assurance, and potential risks in procurement strategies. This article comprehensively examines key loratadine suppliers, their manufacturing capacities, quality standards, and market dynamics to aid stakeholders in making informed decisions.

Overview of Loratadine Supply Chain

Loratadine's supply chain traverses multiple tiers, starting from raw material sourcing, API synthesis, formulation, and finally distribution. The API manufacturing process is highly sensitive, requiring specialized chemical synthesis capabilities, strict quality control, and adherence to regulatory standards such as those outlined by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national authorities.

The API is typically produced in regions with advanced pharmaceutical industries—mainly India, China, and Europe—owing to their manufacturing scale and cost efficiencies. Finished dosage forms are often produced locally or regionally, depending on market demand and regulatory compliance.

Major API Manufacturers of Loratadine

1. Mitsubishi Chemical Corporation (Japan)

   Mitsubishi Chemical is a pioneering producer of loratadine API, leveraging advanced synthetic processes and rigorous quality controls. Their manufacturing facilities comply with Good Manufacturing Practices (GMP), and they often serve large pharmaceutical companies globally. Mitsubishi’s loratadine API is characterized by high purity and consistent batch quality, making it a preferred supplier for many multinational firms.

2. Sun Pharmaceutical Industries Ltd. (India)

   Sun Pharma, among India’s top generic drug manufacturers, also produces loratadine API. Their facilities in India are GMP-certified and serve the sizeable domestic market as well as exports. Sun Pharma maintains a competitive edge through efficient production, cost management, and adherence to international quality standards.

3. Dr. Reddy’s Laboratories (India)

   Dr. Reddy’s operates multiple API facilities with extensive experience in antihistamine production. They supply loratadine API to both domestic formulations and international clients. Their manufacturing processes emphasize scalability, safety, and compliance with global regulatory requirements.

4. Jiangsu Hengrui Medicine Co., Ltd. (China)

   Hengrui is a prominent Chinese API manufacturer offering loratadine API. Their production facilities are GMP-compliant, with a focus on cost-effective manufacturing. Hengrui’s expanding global footprint has increased their presence as a supplier to generic pharmaceutical companies across Asia, Africa, and Latin America.

5. Jubilant Life Sciences (India)

   Now part of Jubilant Pharma**, the company supplies loratadine API with a focus on high quality and consistent supply. Their extensive API manufacturing infrastructure and global distribution network position them as reliable suppliers in emerging markets.

Emerging and Regional Suppliers

While the primary players above dominate the market, several regional suppliers provide loratadine API, particularly catering to local markets or regional pharmaceutical companies. These include smaller Indian, Chinese, and Eastern European manufacturers, often operating under site-specific GMP certifications. However, thorough quality validation remains essential when sourcing from such suppliers.

Quality Standards and Regulatory Considerations

Loratadine API suppliers must meet stringent regulatory standards, including GMP compliance, to ensure safety and efficacy. Many top suppliers obtain certification from international regulatory bodies such as the FDA, EMA, and WHO Prequalification. These certifications guarantee adherence to validated manufacturing processes, impurity profiles, and batch-to-batch consistency.

Most global suppliers also provide documentation on impurity profiles, residual solvents, heavy metal content, and stability data. For companies sourcing loratadine API, verification of these documents and compliance with their target markets’ regulations are critical steps to maintaining product integrity and market access.

Market Trends and Supply Chain Risks

The global loratadine market is influenced by several trends:

• Growing Demand in Emerging Markets: Increased allergy prevalence and expanding healthcare infrastructure drive demand in Asia, Africa, and Latin America.

• Regulatory Scrutiny: Stringent quality requirements and evolving regulations raise barriers for new entrants and favor established, certified suppliers.

• Supply Chain Disruptions: COVID-19 pandemic highlighted vulnerabilities in global API supply chains, particularly dependency on specialized manufacturing regions, prompting companies to diversify sourcing and increase inventory buffers.

• Price Fluctuations: Market competition among large suppliers exerts downward pressure on API prices, affecting profit margins and potential investments in manufacturing enhancements.

Stakeholders must monitor geopolitical developments, regulatory updates, and supply chain resilience strategies, such as supplier diversification and local manufacturing investments.

Key Players’ Market Positioning

Leading API manufacturers like Mitsubishi and Sun Pharma have solidified their positions through advanced manufacturing, regulatory compliance, and patent portfolios. Chinese manufacturers such as Jiangsu Hengrui benefit from lower production costs but face challenges in acquiring global certifications. Smaller regional suppliers often compete on price but struggle with consistent quality assurance.

Conclusion

The loratadine API market features a blend of longstanding multinational corporations and emergent regional players. Ensuring a reliable, high-quality supply hinges on rigorous supplier qualification, thorough due diligence, and ongoing quality assurance. As demand remains robust globally, suppliers investing in manufacturing excellence, regulatory compliance, and supply chain resilience will maintain competitive advantages. Stakeholders should adopt a strategic approach that balances cost, quality, and geopolitical considerations to mitigate risks associated with sourcing loratadine API.

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Key Takeaways

• Major suppliers include Mitsubishi Chemical, Sun Pharma, Dr. Reddy’s, and Jiangsu Hengrui, distinguished by their quality standards and regulatory compliance.

• Quality assurance is paramount—only source loratadine API from GMP-registered manufacturers with appropriate certifications.

• Diversification and resilience are essential strategies to counter global supply chain vulnerabilities, especially amid geopolitical or pandemic-related disruptions.

• Emerging markets offer growth opportunities but require careful validation of supplier compliance and quality assurance processes.

• Regulatory clarity and documentation are critical for maintaining access to international markets and ensuring product safety.

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FAQs

1. What are the main factors to consider when sourcing loratadine API?
Manufacturers should verify GMP certification, regulatory compliance, impurity profiles, batch consistency, and the supplier’s reputation for quality and reliability.

2. Are Chinese loratadine API manufacturers suitable for global markets?
Many Chinese suppliers, such as Jiangsu Hengrui, meet international GMP standards and hold certifications from regulatory agencies, making them suitable. However, due diligence is necessary to confirm compliance with specific market requirements.

3. How does geopolitical risk influence loratadine supply chains?
Trade tensions, export restrictions, or regional disruptions can affect API availability. Diversifying suppliers across different regions mitigates risks.

4. What impact does supply chain disruption have on loratadine availability?
Disruptions can lead to shortages, delays, and increased prices. Maintaining buffer stocks and engaging multiple qualified suppliers enhances supply chain resilience.

5. Is there a trend toward local manufacturing of loratadine APIs?
Yes, several regulatory agencies and companies encourage local or regional API production to reduce dependency on international supply chains, especially in response to recent disruptions.

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Sources:

1. [1] U.S. Food and Drug Administration (FDA). Guidance on API manufacturing standards.
2. [2] European Medicines Agency (EMA). Good Manufacturing Practice (GMP) guidelines.
3. [3] Market research reports on antihistamine APIs, 2022-2023.
4. [4] Company websites of Mitsubishi Chemical, Sun Pharma, Dr. Reddy’s, Jiangsu Hengrui.
5. [5] Industry analyses on global supply chain resilience in pharmaceuticals.