Bulk Pharmaceutical API Sources for EFIDAC 24 CHLORPHENIRAMINE MALEATE

Bulk Pharmaceutical API Sources for EFIDAC 24 CHLORPHENIRAMINE MALEATE

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		C3025_SIGMA
TCI (Tokyo Chemical Industry)		C0873
Molport		MolPort-003-845-934
Hangzhou APIChem Technology		AC-267

Bulk Active Pharmaceutical Ingredient (API) Sources for EFIDAC 24 CHLORPHENIRAMINE MALEATE

Last updated: July 31, 2025

Introduction

Chlorpheniramine maleate is an antihistamine extensively used to treat allergic conditions such as hay fever, allergic rhinitis, and urticaria. EFIDAC 24 is a specific formulation that incorporates chlorpheniramine maleate to deliver rapid symptom relief. The global demand for this API has escalated owing to its widespread therapeutic use, prompting pharmaceutical companies to explore reliable sourcing channels. This article evaluates key bulk API suppliers for chlorpheniramine maleate, emphasizing quality standards, regulatory compliance, and market dynamics, to aid pharmaceutical manufacturers and investors’ strategic decision-making.

Overview of Chlorpheniramine Maleate

Chlorpheniramine maleate is a first-generation antihistamine characterized by high affinity for histamine H1 receptors. Its chemical composition is C16H19ClN2•C4H4O4, with a molecular weight of approximately 398.3 g/mol. It inhibits the effects of histamine, easing symptoms like sneezing, runny nose, and watery eyes. As a bulk API, production quality, purity, and stability are critical, with strict adherence to pharmacopeial standards such as USP, EP, or BP.

Key Sources of Chlorpheniramine Maleate API

1. Indian Manufacturers

India remains a dominant global supplier of generic APIs owing to cost advantages, extensive manufacturing infrastructure, and compliance capabilities.

A. Divi's Laboratories

• Overview: A worldwide leader in bulk APIs, Divi's Laboratories maintains GMP-certified manufacturing facilities and adheres to international quality standards.
• API Quality: Their chlorpheniramine maleate API complies with USP and EP monographs.
• Supply Chains & Capacity: Capable of large-scale bulk supply, with export to over 100 countries.
• Regulatory Approvals: Approved by major regulatory agencies including US FDA, EUGMP, and MHRA.

B. Jubilant Life Sciences

• Overview: Jubilant, with extensive expertise in steroidal and antihistamine APIs, offers high-quality chlorpheniramine maleate.
• Quality Standards: Meets stringent quality controls aligned with global pharmacopeias.
• Market Penetration: Supplies to large pharmaceutical firms worldwide, with ISO and GMP certifications.

C. Hetero Labs

• Profile: Known for robust R&D capabilities, Hetero Labs supplies pharmaceutical ingredients with a focus on compliance.
• API Reliability: Ensures consistent purity standards suitable for finished formulations.

2. Chinese API Manufacturers

China remains a crucial API production hub, with numerous companies capable of large-volume manufacturing.

A. Zhejiang Hisun Pharmaceutical

• Product Range: Offers chlorpheniramine maleate API packaged with high purity levels.
• Standards & Certifications: Compliant with ISO, GMP, and FDA standards.
• Market Strategy: Focuses on competitive pricing while maintaining quality.

B. North China Pharmaceutical Group Corporation (NCPC)

• Capabilities: Produces chlorpheniramine maleate in compliance with pharmacopeial standards.
• Export & Supply: Competitive lead times, serving large international markets.

C. Zhejiang Medicine Co., Ltd

• Strengths: Maintains comprehensive quality assurance measures, ensuring batch-to-batch consistency.

3. European and US-Based API Suppliers

While less prevalent, several specialized manufacturers in the US and Europe provide high-purity chlorpheniramine maleate APIs.

A. Aenova Group

• Profile: A European API supplier renowned for high-quality control.
• Regulatory Focus: Facilitates seamless registration in regulated markets owing to strict compliance and documentation.

B. Patheon (a part of Thermo Fisher Scientific)

• Expertise: Offers custom manufacturing of APIs for specialized pharmaceutical applications, including chlorpheniramine maleate, with an emphasis on cGMP compliance.

4. Factors Influencing API Sourcing Decisions

• Quality Assurance: Suppliers must provide Certificates of Analysis (CoA) adhering to pharmacopoeial standards.
• Regulatory Compliance: Suppliers should hold certifications such as US FDA, EMA GMP, or PIC/S.
• Capacity & Reliability: Ability to meet volume demands without compromising quality.
• Pricing & Lead Times: Competitive pricing combined with reliable supply schedules.
• Traceability & Documentation: Transparent supply chain initiatives to prevent adulteration or contamination.

Quality Standards & Regulatory Considerations

• Pharmacopeial Standards: Ensuring APIs conform to USP, EP, or BP monographs.
• Validation & Certification: Suppliers must demonstrate cGMP compliance, API batch validation, and in some cases, in-house stability data.
• Import Regulations: International suppliers should be prepared for import prequalification procedures specific to each target market.

Current Market Trends & Challenges

• Supply Chain Disruptions: Global events, such as pandemics and geopolitical tensions, have disrupted API logistics, emphasizing the need for diversified sourcing.
• Quality vs. Cost Paradox: While cheaper Chinese suppliers dominate, regulatory scrutiny mandates diligent quality verification.
• Environmental and Sustainability Standards: Increasingly, suppliers adhere to eco-friendly manufacturing practices to meet global standards and client expectations.

Future Outlook

The supply landscape is shifting towards increased capacity building in India and China, with a rising emphasis on quality and compliance. Emerging markets are heavily reliant on reputable Asian suppliers with GMP-certified manufacturing capabilities. Regulatory bodies’ tightening—especially in the US and Europe—further underscores the importance of sourcing from compliant manufacturers.

Conclusion

Securing high-quality bulk API sources for EFIDAC 24 chlorpheniramine maleate requires strategic vetting of global suppliers. Indian manufacturers like Divi's Laboratories, Jubilant Life Sciences, and Hetero Labs lead due to their proven quality, capacity, and regulatory compliance. Chinese firms such as Zhejiang Hisun and NCPC remain cost-effective alternatives with reliable quality controls. European and US-based suppliers offer high-end API options suitable for highly regulated markets. Deciding among these suppliers hinges on the balance between cost, regulatory compliance, supply reliability, and quality assurance.

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Key Takeaways

• Indian API manufacturers dominate the chlorpheniramine maleate market due to reliable quality and competitive pricing.
• Regulatory compliance, notably GMP certification and pharmacopeial adherence, is non-negotiable for suppliers.
• Diversification of sources mitigates risks associated with geopolitical and supply chain disruptions.
• Maintaining rigorous quality assurance processes is critical for API safety and regulatory approval.
• Ongoing market evolution favors suppliers investing in eco-friendly manufacturing and transparent supply chains.

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FAQs

1. What are the leading global suppliers of chlorpheniramine maleate API?
Indian manufacturers such as Divi's Laboratories, Jubilant Life Sciences, and Hetero Labs are the primary global suppliers, complemented by Chinese companies like Zhejiang Hisun Pharmaceutical and NCPC.

2. How do I verify the quality of bulk chlorpheniramine maleate APIs?
Verify Certificates of Analysis (CoA), ensure compliance with pharmacopeial standards (USP, EP), and confirm GMP certification. Conduct or review batch validation and stability testing data.

3. What regulatory considerations should be made when sourcing API internationally?
Select suppliers with approved GMP certifications (FDA, EMA), and ensure their manufacturing practices meet target market requirements. Also, review import clearance procedures and documentation.

4. How does pricing influence API sourcing decisions?
While cost is significant, compromised quality can jeopardize regulatory approval and product safety. Balance cost advantages with long-term quality assurance and regulatory compliance.

5. What are the future trends impacting API sourcing for chlorpheniramine maleate?
Shifts toward increased capacity in India and China, stricter global regulatory standards, and sustainability initiatives are shaping sourcing strategies. Diversification and supplier audits are becoming increasingly vital.

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Sources

[1] US Pharmacopoeia. "Chlorpheniramine Maleate Monograph." 2022.
[2] European Pharmacopoeia. "Chlorpheniramine Maleate." 2021.
[3] Industry Reports on API Market Dynamics. 2022.
[4] Company websites and regulatory filings of Divi’s Laboratories, Jubilant Life Sciences, Hetero Labs, Zhejiang Hisun, NCPC.