DESLORATADINE; PSEUDOEPHEDRINE SULFATE: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Organon Llc	CLARINEX-D 12 HOUR	desloratadine; pseudoephedrine sulfate	TABLET, EXTENDED RELEASE;ORAL	021313	NDA	Organon LLC	78206-120-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (78206-120-01)	2021-06-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

The global pharmaceutical landscape relies heavily on a diversified supply chain to meet the demand for both prescription and over-the-counter medications. Two notable active pharmaceutical ingredients (APIs)—desloratadine and pseudoephedrine sulfate—are pivotal in allergy and respiratory treatments. Understanding the key suppliers for these compounds offers insights into supply chain stability, regulatory compliance, and market dynamics crucial for stakeholders—including pharmaceutical manufacturers, regulators, and investors.

This article provides a comprehensive overview of the primary suppliers for desloratadine and pseudoephedrine sulfate, highlighting manufacturing hubs, market share, sourcing trends, and regulatory considerations. The analysis aims to inform strategic sourcing decisions and foster supply chain resilience amid geopolitical and regulatory shifts.

Desloratadine Suppliers: Market Overview and Key Players

Description and Market Importance

Desloratadine is a third-generation antihistamine used predominantly to treat allergic rhinitis and chronic idiopathic urticaria. Its pharmaceutical production involves complex synthesis, and global supply hinges on a few dominant API manufacturers, primarily situated in Asia, Europe, and North America.

Leading Suppliers and Manufacturing Hubs

1. Sandoz (Novartis Group)

Sandoz, a division of Novartis, is a significant supplier of desloratadine. With manufacturing facilities in Switzerland and India, Sandoz benefits from extensive R&D and manufacturing expertise, producing high-quality APIs compliant with international standards. Their market reach extends globally, supplying both finished dosage forms and APIs.

2. Alkem Laboratories

An Indian pharmaceutical manufacturer, Alkem is among the prominent producers of desloratadine API. Their manufacturing plants are located in India, leveraging lower-cost production capabilities and strict compliance with cGMP standards to meet global demand.

3. Aurobindo Pharma

Another Indian API manufacturer, Aurobindo has significant expertise in antihistamines, with API manufacturing facilities in Hyderabad and elsewhere. They have expanded their capacity over recent years, aligning with increasing demand.

4. Mylan (Now part of Viatris)

Viatris, formed from Mylan and Pfizer’s off-patent drug assets, manufactures desloratadine in various facilities, particularly focusing on North American supply chains. Their production plants conform to high regulatory standards, ensuring consistent quality.

5. Other Notable Suppliers

Chinese generic manufacturers such as Jiangxi Qingfeng Pharmaceutical Co., Ltd., and Lupin Pharmaceuticals (India) also contribute to the global supply, though these tend to serve regional markets more heavily.

Regulatory and Compliance Factors

Manufacturers must adhere to stringent standards such as cGMP, and supply chains are often scrutinized by global agencies like the FDA, EMA, and PMDA. Recent regulatory trends favor transparency and batch-level traceability, impacting sourcing strategies.

Pseudoephedrine Sulfate Suppliers: Market Dynamics and Challenges

Description and Regulatory Landscape

Pseudoephedrine sulfate is a potent sympathomimetic agent used as a decongestant. Its manufacturing and distribution are heavily regulated under the Combat Methamphetamine Epidemic Act (CMEA) in the United States and similar regulations globally, owing to its use as a precursor in methamphetamine production.

Key Suppliers and Global Sourcing

1. Chinese Manufacturers

China dominates the supply of pseudoephedrine sulfate, with major firms such as Zhejiang Huahai Pharmaceutical, Jiangsu Jiaermei, and Shandong Xinhua Pharmaceutical producing large quantities. Chinese APIs benefit from cost advantages but face regulatory hurdles in Western markets.

2. Indian API Producers

India’s pharmaceutical industry, led by companies like Strides Pharma Science Ltd., and Sun Pharmaceutical Industries Ltd., supplies pseudoephedrine sulfate primarily for regional markets. India’s under stringent export controls, but regulatory bodies maintain high-quality standards—products often audited by global agencies.

3. European Suppliers

European pharmaceutical companies such as Novartis and Teva manufacture pseudoephedrine sulfate, mainly for regional distribution. They prioritize regulatory compliance, quality assurance, and documentation.

4. Latin American and Other Markets

Brazilian and Mexican firms, such as União Química (Brazil), also contribute to regional supplies with robust manufacturing standards complying with local regulations.

Supply Chain Challenges and Regulatory Considerations

The high regulation of pseudoephedrine, including mandatory licensing and reporting, constrains supply flexibility. Manufacturers often face periodic shortages due to regulatory oversight, crackdowns on illicit diversion, and international trade restrictions.

Efforts to establish transparent supply chain frameworks have led to increased reliance on established suppliers with verified compliance records. Recent international partnerships aim to diversify sources and reduce dependency on any single region.

Market Trends and Future Outlook

Supply Chain Diversification

Manufacturers increasingly seek diversified sourcing strategies for both desloratadine and pseudoephedrine sulfate to mitigate geopolitical risks and regulatory bottlenecks. The trend toward local production and strategic stockpiling is evident, especially post-COVID-19.

Regulatory Impact on Supply Chains

Stringent regulatory frameworks continue to influence supplier selection, necessitating suppliers to maintain high compliance standards, undergo regular audits, and adapt to evolving legal requirements. The push toward transparent and traceable supply chains favors manufacturers with established regulatory track records.

Emerging Manufacturing Hubs

Emerging markets such as Southeast Asia and Eastern Europe are gaining prominence as alternative manufacturing hubs, offering competitive costs and strategic geographic positioning. This diversification aims to enhance supply stability for critical APIs.

Key Takeaways

Dominant Suppliers: For desloratadine, leading manufacturers include global pharma giants like Sandoz and regional players in India and China. Pseudoephedrine sulfate suppliers are primarily based in China, with significant contributions from India and Europe.
Regional Trends: While China remains the primary source for pseudoephedrine sulfate, regulatory pressures encourage diversification. Desloratadine supply is more geographically dispersed, with Europe, India, and North America leading.
Regulatory Compliance: Stringent quality and compliance standards significantly influence sourcing decisions. Suppliers who demonstrate consistent adherence to cGMP and traceability are preferred.
Supply Chain Resilience: Diversification, strategic stockpiling, and regional manufacturing development are vital responses to geopolitical risks, regulatory changes, and market volatility.
Future Outlook: The ongoing shift toward transparency, regulatory alignment, and supply chain diversification will shape the global procurement landscape for both APIs.

FAQs

1. Who are the top global suppliers for desloratadine?
Major worldwide suppliers include Sandoz (Novartis), Aurobindo Pharma, Alkem Laboratories, and Viatris (formerly Mylan). These companies have extensive manufacturing facilities in Europe, India, and North America, ensuring broad geographic coverage.

2. Why is China the dominant supplier of pseudoephedrine sulfate?
China’s manufacturing infrastructure provides cost-effective, high-volume production of pseudoephedrine sulfate. However, strict international and domestic regulation of precursor chemicals influences supply dynamics and encourages diversification.

3. How do regulations impact the sourcing of pseudoephedrine sulfate?
Heavy regulation requires licensing, tracking, and reporting of pseudoephedrine transactions, limiting some suppliers’ ability to supply large quantities, and prompting buyers to verify compliance meticulously.

4. Are there regional restrictions affecting desloratadine supply?
While desloratadine production is less regulated than pseudoephedrine sulfate, regional approvals (like FDA, EMA, or PMDA) and export controls influence the movement of APIs, especially regarding quality standards and patent considerations.

5. What future trends will influence API supplier choices?
Increased emphasis on regulatory compliance, supply chain transparency, diversification, and regional manufacturing capacity expansion will drive supplier selection. Emerging markets like Southeast Asia are poised to become pivotal in the future.

Sources

[1] IQVIA. "The Global APIs Market Report," 2022.
[2] US FDA. "Regulations on Pseudoephedrine," 2023.
[3] European Medicines Agency. "Guidelines for API Manufacturing," 2022.
[4] Pharma Intelligence. "Desloratadine Market Analysis," 2022.
[5] GlobalData. "API Supply Chain Trends," 2023.

Suppliers and packagers for generic pharmaceutical drug: DESLORATADINE; PSEUDOEPHEDRINE SULFATE