CLEMASTINE FUMARATE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Genus	CLEMASTINE FUMARATE	clemastine fumarate	SYRUP;ORAL	073399	ANDA	Genus Lifesciences	64950-324-12	120 mL in 1 BOTTLE (64950-324-12)	2024-11-22
New Heightsrx	CLEMASTINE FUMARATE	clemastine fumarate	SYRUP;ORAL	074884	ANDA	Chartwell RX, LLC	62135-713-41	120 mL in 1 BOTTLE (62135-713-41)	1997-12-17
Genus	CLEMASTINE FUMARATE	clemastine fumarate	TABLET;ORAL	073283	ANDA	Teva Pharmaceuticals USA, Inc.	0093-0308-01	100 TABLET in 1 BOTTLE (0093-0308-01)	1992-04-01
Genus	CLEMASTINE FUMARATE	clemastine fumarate	TABLET;ORAL	073283	ANDA	Genus Lifesciences	64950-268-03	30 TABLET in 1 BOTTLE (64950-268-03)	2024-11-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 28, 2025

Introduction

Clemastine fumarate, an antihistamine primarily used to treat allergic conditions such as hay fever, allergic conjunctivitis, and hives, has garnered increasing demand in both established and emerging markets. As a widely prescribed first-generation antihistamine, it is often included in combination therapies for allergy relief and is pivotal in various clinical settings. Identifying reliable suppliers for clemastine fumarate is essential for pharmaceutical manufacturers, contract research organizations (CROs), and healthcare providers aiming to ensure product quality, regulatory compliance, and supply chain stability.

Manufacturers of Active Pharmaceutical Ingredients (API) for Clemastine Fumarate

The primary source of clemastine fumarate is its active pharmaceutical ingredient (API), which is produced by specialized chemical and pharmaceutical companies. These manufacturers operate across different regions, including Asia, Europe, and North America, with some companies demonstrating a proven track record for quality, compliance, and reliable supply.

Global API Manufacturers

1. Jiangsu Hengrui Medicine Co., Ltd. (China)
A leading Chinese pharmaceutical company with extensive experience in synthesizing antihistamine APIs, Jiangsu Hengrui is recognized for its high-quality selenium compounds and APIs for allergy medications such as clemastine fumarate. The company's manufacturing facilities are certified by the FDA (USA) and EMA (Europe), ensuring compliance with international standards.

2. Zheijiang Tianyu Pharmaceutical Co., Ltd. (China)
Specialized in the synthesis of pharmaceutical intermediates and APIs, Zheijiang Tianyu offers high-purity clemastine fumarate suitable for pharmaceutical formulations. Their product portfolio emphasizes stability, purity, and consistent batch-to-batch quality, making them a favored partner for global pharmaceutical firms.

3. Nanjing Tiansong Biotechnology Co., Ltd. (China)
A fast-growing API producer, Nanjing Tiansong supplies clemastine fumarate with rigorous quality controls and comprehensive documentation, including batch records, spectroscopic data, and impurity profiles aligned with regulatory expectations.

4. TCI Chemicals (Japan/Global)
Although primarily known for specialty chemicals, TCI produces pharmaceutical-grade APIs, including derivatives of antihistamines. Their globally distributed APIs are manufactured under strict cGMP (current Good Manufacturing Practices) and are exported worldwide.

5. Sanofi (France)
As a large-scale pharmaceutical corporation, Sanofi is involved in the manufacturing or licensing of APIs, including antihistamines. Sanofi’s global supply chain encompasses high-standard APIs complying with global regulatory standards.

Regional and Parenteral API Suppliers

While Chinese API producers dominate the market, European companies such as H. & H. Pharma and Euromed also manufacture clemastine fumarate to serve markets with stringent quality standards.

Contract Manufacturing Organizations (CMOs) and Exporters

Many pharmaceutical companies outsource manufacturing or distribution through CMOs, which often serve as reliable intermediaries. When sourcing clemastine fumarate, it is critical to verify the CMO's compliance certificates, quality assurance protocols, and production capacities.

Lonza (Switzerland): Known for high-quality chemical manufacturing, Lonza offers contract synthesis services for pharmaceutical APIs, including antihistamines.
Bachem (Switzerland): Specializes in custom synthesis and may produce intermediates or APIs used in antihistamine formulations.
Patheon (Part of Thermo Fisher Scientific): Offers manufacturing of APIs per global standards, including for antihistamines such as clemastine fumarate.

Regulatory Considerations in Supplier Selection

When choosing suppliers, regulatory compliance is paramount. Qualified suppliers should possess:

Current Good Manufacturing Practice (cGMP) certification
Inspections and audits by regulatory agencies
Comprehensive documentation for traceability
Validated analytical data demonstrating purity and potency

The legal framework governing API supply chains—particularly in the US, EU, and Asia—mandates strict adherence to quality standards, making regulatory certification a critical selection criterion.

Supply Chain Challenges and Strategic Sourcing

The global API market faces challenges including raw material availability, geopolitical tensions, and manufacturing disruptions. Suppliers in China and India dominate the market for intermediates and APIs due to cost advantages, but recent regulatory scrutiny emphasizes supply chain diversification.

Multinational pharmaceutical companies often adopt risk mitigation strategies such as dual sourcing, inventory buffering, and establishing direct supplier partnerships. Ensuring regulatory compliance and quality assurance across suppliers reduces supply chain vulnerabilities for clemastine fumarate.

Emerging Trends and Future Outlook

The pharmaceutical industry is increasingly leveraging advanced manufacturing techniques such as continuous flow synthesis and process intensification to improve yield, purity, and scalability for antihistamine APIs like clemastine fumarate. Additionally, regional regulations are pushing for localized API production hubs in North America and Europe, which could reshape global supply chains.

Biotech firms and chemical syntheses companies are also exploring greener, more sustainable manufacturing processes to meet environmental standards, potentially influencing future supplier selections.

Key Regulatory and Quality Assurance Insights

GMP Certification: Ensure suppliers possess valid cGMP certification aligned with FDA, EMA, or equivalent authorities.
Analytical Data: Require detailed quality control records, including HPLC purity profiles, impurity analyses, and stability data.
Batch Consistency: Confirm suppliers demonstrate consistent batch-to-batch quality to prevent supply disruptions.
Regulatory Submissions: Verify if existing suppliers have API approval or acknowledgment in key regulatory jurisdictions.

Conclusion

Global suppliers for clemastine fumarate span reputable Chinese API manufacturers, European chemical companies, and contract manufacturers with proven compliance and quality standards. For pharmaceutical firms, establishing reliable, compliant supply relationships involves rigorous due diligence, including certification verification, supply chain resilience strategies, and aligned quality control protocols.

As demand persists, suppliers' ability to meet regulatory standards, ensure predictable delivery, and sustain high-quality production will shape the market landscape. Strategic sourcing choices rooted in quality, compliance, and supply chain stability remain essential for ensuring uninterrupted availability of clemastine fumarate.

Key Takeaways

Global API providers such as Jiangsu Hengrui, Zheijiang Tianyu, and TCI are leading suppliers of clemastine fumarate.
Regulatory compliance, especially cGMP certification, is crucial for supplier selection.
Supply chain resilience requires diversification, strategic partnerships, and inventory management.
Emerging manufacturing techniques and regulatory trends are influencing future supplier landscapes.
Due diligence and quality assurance are fundamental to sourcing high-quality clemastine fumarate for pharmaceutical applications.

FAQs

1. What are the primary regions manufacturing clemastine fumarate APIs?
Chinese companies dominate, with notable manufacturers in China; European firms also produce high-quality APIs, especially for regulated markets.

2. How do I verify the quality of a clemastine fumarate API supplier?
Request GMP certificates, detailed analytical data, batch records, and conduct or review supplier audits and inspections.

3. Are there alternative suppliers to Chinese API manufacturers?
Yes, European manufacturers such as H. & H. Pharma and contract manufacturers like Lonza and Bachem provide alternative sources with stringent quality standards.

4. What are key factors to consider when sourcing clemastine fumarate APIs?
Regulatory compliance, product purity, batch consistency, supply reliability, and certification are critical.

5. How might future regulations impact clemastine fumarate suppliers?
Regulations emphasizing environmental sustainability and supply chain transparency could lead to new manufacturing standards and regional production shifts.

Sources:

[1] Medicines and Healthcare products Regulatory Agency (MHRA), API sourcing guidelines.
[2] European Medicines Agency (EMA), API manufacturing standards.
[3] COMPANY websites and published certifications of Jiangsu Hengrui, Zheijiang Tianyu, and TCI.
[4] Industry reports on global antihistamine API manufacturing trends.

Suppliers and packagers for generic pharmaceutical drug: CLEMASTINE FUMARATE