Bulk Pharmaceutical API Sources for KERLEDEX

Bulk Pharmaceutical API Sources for KERLEDEX

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		2369
MolPort		MolPort-003-845-027
Hangzhou APIChem Technology		AC-1115
ABI Chem		AC1L1DIZ
ISpharm		I14-16995
ChemMol		30108742

Bulk Active Pharmaceutical Ingredient (API) Sources for KERLEDEX

Last updated: July 29, 2025

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Introduction

KerleDEX, a widely prescribed combination medication, integrates dextromethorphan (DXM) and chlorpheniramine (CPM) for symptomatic relief of cough and cold. The effectiveness and safety profile of KerleDEX significantly depend on the consistent quality of its active pharmaceutical ingredients (APIs)—primarily dextromethorphan hydrobromide and chlorpheniramine maleate. Ensuring a reliable, high-quality source of these APIs is essential for pharmaceutical manufacturers, regulatory compliance, and patient safety. This article systematically explores the key global API suppliers providing bulk dextromethorphan and chlorpheniramine suitable for KerleDEX manufacturing.

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Overview of API Requirements for KerleDEX

Dextromethorphan hydrobromide and chlorpheniramine maleate are critical APIs with specific synthesis pathways, purity standards, and regulatory criteria. APIs intended for cough and cold formulations must meet strict quality standards, including:

• USP, EP, or ICH compliance
• Bioequivalence and potency consistency
• Low impurity levels
• Stability profiles suitable for oral liquids

Manufacturers often seek suppliers with Good Manufacturing Practice (GMP) certification, validated processes, and a proven track record for consistent batch quality.

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Global API Suppliers for Dextromethorphan Hydrobromide

1. Piramal Pharma Solutions

• Overview: A leading API manufacturer with extensive capabilities in synthetic APIs, including dextromethorphan hydrobromide.
• Supply scope: Bulk quantities compliant with regulatory standards (USP, EP).
• Strengths: Robust quality systems, validated manufacturing processes, and global distribution.
• Certifications: GMP, ISO 9001, and other relevant regulatory certifications.

2. Jiangsu Hengrui Medicine Co., Ltd.

• Overview: Chinese pharmaceutical major producing a broad spectrum of APIs, including dextromethorphan hydrobromide.
• Supply scope: Bulk API for finished dosage forms, with international export capabilities.
• Strengths: Cost-effective manufacturing, adherence to international quality standards, and verified GMP certification.
• Regulatory status: Approved for export to North America, Europe, and Asia.

3. Asymchem Laboratories

• Overview: A global contract manufacturer with expertise in synthesizing and supplying high-quality APIs.
• Supply scope: Dextromethorphan hydrobromide in bulk, with tailored packaging solutions.
• Strengths: Advanced process controls, strong quality assurance, and strategic partnerships with pharma companies.

4. Hubei Weihua Pharmaceutical Co., Ltd.

• Overview: China-based API producer with focus on cough suppressant APIs.
• Supply scope: Bulk dextromethorphan hydrobromide conforming to international standards.
• Strengths: Cost efficiency, established supply chain, and GMP-certified facilities.

Global API Suppliers for Chlorpheniramine Maleate

1. Tregon Laboratories (part of Ajinomoto Bio-Pharma Servcies)

• Overview: Recognized manufacturer of antihistamines, including chlorpheniramine maleate.
• Supply scope: Bulk chlorpheniramine maleate for pharmaceutical use.
• Strengths: High purity standards, consistent supply, and comprehensive documentation for regulatory compliance.

2. Richwood Pharmaceuticals

• Overview: A reputable supplier specializing in antihistamine APIs.
• Supply scope: Chlorpheniramine maleate with GMP certification suitable for oral formulations.
• Strengths: Proven quality, reliable delivery timelines, and competitive pricing.

3. Zhejiang Medicine Co., Ltd.

• Overview: A major Chinese pharmaceutical producer with significant API manufacturing capabilities.
• Supply scope: Chlorpheniramine maleate in bulk batches meeting USP/EP standards.
• Strengths: Cost-effective manufacturing, compliance with global regulatory standards, and extensive distribution networks.

4. Thermo Fisher Scientific

• Overview: A global leader in biopharmaceutical supplies, including high-grade APIs.
• Supply scope: Custom synthesis and bulk chlorpheniramine maleate.
• Strengths: Stringent quality controls, readiness for regulatory audits, and multi-regional certifications.

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Criteria for API Supplier Selection

When sourcing APIs for KerleDEX, manufacturers must evaluate potential suppliers based on:

• Regulatory compliance: Certification such as GMP, ISO, and adherence to regional pharmacopeias.
• Quality assurance: Batch-to-batch consistency, impurity profiling, and stability data.
• Supply stability: Production capacity, lead times, and contingency planning.
• Cost and logistics: Competitive pricing, shipping reliability, and geographic considerations.
• Technical support: Ability to provide detailed documentation, impurity profiles, and QA/QC data.

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Emerging Trends in API Sourcing for Cough and Cold Medications

The API sourcing landscape continues evolving toward increased reliance on local manufacturing hubs within North America and Europe, driven by regulatory tightening and supply chain resilience imperatives. Simultaneously, Chinese and Indian API producers maintain dominance due to cost competitiveness and manufacturing scale, especially in APIs like dextromethorphan and chlorpheniramine.

Manufacturers increasingly favor API outsourcing models with robust contract manufacturing organizations (CMOs) that offer integrated quality management. Moreover, the rise of sustainable manufacturing practices emphasizes eco-friendly processes, which influence supplier choices.

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Regulatory and Quality Assurance Considerations

Sourcing APIs globally requires rigorous due diligence. Ensuring APIs conform to ICH Q7 guidelines, with comprehensive documentation, impurity profiles, and stability data, is non-negotiable. Regulatory agencies such as the FDA, EMA, and PMDA scrutinize API manufacturing facilities during audits; thus, suppliers with validated GMP facilities and recent inspection reports are preferred.

Additionally, manufacturers must consider testing and analytical methods used by suppliers for API quality verification, ensuring transparency and traceability.

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Conclusion: Strategic API sourcing for KerleDEX

A robust supply chain hinges on identifying reputable API manufacturers that meet stringent quality, regulatory, and logistical standards. For KerleDEX, reliable sources of dextromethorphan hydrobromide and chlorpheniramine maleate include established Chinese, Indian, and Western pharmaceutical API producers. Strategic partnerships with contracted manufacturers with proven compliance and supply stability will safeguard production continuity and product quality.

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Key Takeaways

• Quality is paramount: Certified API suppliers with rigorous QA systems ensure medication safety and efficacy.
• Diversify sourcing: Combining suppliers across regions mitigates supply chain risks.
• Regulatory compliance: Select vendors with established GMP certifications aligned with target markets.
• Cost vs. quality: Cost advantages should not compromise adherence to international quality standards.
• Future trends: Growing emphasis on sustainable and localized API manufacturing influences sourcing decisions.

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FAQs

1. How do I verify the quality of APIs from international suppliers?
Conduct comprehensive supplier audits, review GMP certification status, request API analytical reports, and verify compliance with regional pharmacopeias (USP, EP). Using third-party analytical testing laboratories for independent verification is also recommended.

2. What are common challenges in sourcing APIs for cough and cold formulations?
Challenges include ensuring consistent impurity profiles, managing supply chain disruptions, navigating differing regional quality standards, and maintaining regulatory compliance across markets.

3. Are Chinese API producers suitable for KerleDEX manufacturing?
Yes. Many Chinese API manufacturers operate GMP-certified facilities adhering to international standards, offering high-quality APIs at competitive prices. Due diligence and quality verification are essential.

4. How important is regulatory approval for API suppliers?
Crucial. Suppliers with established regulatory approvals facilitate faster registration, market access, and ensure ongoing compliance with evolving standards.

5. How can manufacturers ensure ongoing API supply stability?
By establishing long-term agreements, diversifying supplier bases, maintaining safety stock levels, and engaging with suppliers demonstrating robust capacity planning.

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References

[1] USP Monographs on Dextromethorphan and Chlorpheniramine. United States Pharmacopeia, 2022.
[2] ICH Q7 Guideline for Good Manufacturing Practice for Active Pharmaceutical Ingredients, 2020.
[3] Regulatory reports on global API manufacturing standards, EMA and FDA inspection reports.
[4] Industry reports on global API supply chains, IQVIA, 2022.
[5] Public disclosures from leading API producers: Piramal Pharma Solutions, Jiangsu Hengrui, and others.