Bulk Pharmaceutical API Sources for brompheniramine maleate

Bulk Pharmaceutical API Sources for brompheniramine maleate

Vendor	Vendor Homepage	Vendor Sku	API Url
MolPort		MolPort-003-666-520
Hangzhou APIChem Technology		AC-1311
ABI Chem		AC1NQXZ5
ChemMol		30106904
ChemMol		44004984
ABBLIS Chemicals		AB2000679
BioChemPartner		BCPP000315

Bulk Active Pharmaceutical Ingredient (API) Sources for: BROMPHENIRAMINE MALEATE

Last updated: July 29, 2025

Introduction

Brompheniramine maleate is a first-generation antihistamine widely used to alleviate allergic symptoms, including hay fever, rhinitis, and urticaria. As an essential pharmaceutical ingredient, its sourcing is critical to ensure product efficacy, safety, and regulatory compliance. This article examines the global API supply landscape for brompheniramine maleate, focusing on reputable manufacturing regions, leading suppliers, regulatory considerations, and strategic procurement insights.

Global API Manufacturing Landscape

The manufacturing of brompheniramine maleate is concentrated primarily in select regions known for robust pharmaceutical production capabilities—India, China, and Eastern Europe. These regions benefit from established chemical synthesis expertise, cost advantages, and a growing presence in generic drug supply chains.

• India: Renowned for its extensive API manufacturing industry, India hosts numerous WHO-GMP certified facilities producing brompheniramine maleate (e.g., Aarti Drugs, Hetero Labs). Indian API suppliers often serve both domestic and international markets, complying with strict quality standards to meet global regulatory barriers (e.g., USFDA, EMA).

• China: With a sizeable chemical synthesis sector, Chinese manufacturers like Zhejiang Chenxin Pharmaceutical Co. and Yantai Guoer Pharmaceutical Co. produce brompheniramine maleate. They frequently offer competitive pricing and large-scale capacity, although regulatory oversight varies.

• Eastern Europe: Countries such as Hungary and Poland host API producers with high regulatory standards, including certifications aligned with the European Union Good Manufacturing Practices (EU-GMP).

Leading Suppliers and Manufacturing Companies

Identifying reputable API suppliers is crucial to mitigate risks related to quality, supply continuity, and regulatory compliance. Prominent companies involved in brompheniramine maleate production include:

• Aarti Drugs Ltd. (India): An ISO 9001 and WHO-GMP-certified manufacturer offering brompheniramine maleate with consistent quality and reliable supply.

• Hetero Labs (India): With a diversified API portfolio, Hetero supplies brompheniramine maleate suitable for international markets, adhering to stringent quality standards.

• Zhejiang Chenxin Pharmaceutical Co. (China): Known for bulk chemical synthesis, with capabilities for large-scale production and export licensing.

• Yantai Guoer Pharmaceutical Co. (China): Provides bulk APIs with certifications supporting global distribution.

• Krka (Slovenia): A European manufacturer with high regulatory standards and compliance across markets, including brompheniramine maleate.

Regulatory Considerations for API Sourcing

Regulatory scrutiny is pivotal when selecting API suppliers. Regulatory agencies such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Pharmaceuticals and Medical Devices Agency (PMDA) in Japan set strict manufacturing, quality control, and documentation standards.

• Quality Certifications: Suppliers should possess current Good Manufacturing Practice (GMP) certifications, preferably recognized globally (e.g., WHO-GMP, EU-GMP, FDA-approved facilities).

• Regulatory Submissions and Documentation: Adequate process validation reports, Material Safety Data Sheets (MSDS), and Certificate of Analysis (CoA) must accompany API batches, ensuring compliance with target markets.

• Traceability and Supply Chain Transparency: Suppliers with clear traceability and robust compliance histories mitigate regulatory risks.

Procurement Strategies and Risk Management

The selection process for brompheniramine maleate APIs must balance cost, quality, and supply security. Companies should consider:

• Diversification of Suppliers: Avoid over-reliance on a single source to mitigate geopolitical, logistical, or regulatory disruptions.

• Supplier Qualification: Conduct comprehensive audits and qualification assessments before onboarding new suppliers.

• Long-term Contracts: Establish agreements that ensure price stability, priority access during shortages, and regulatory compliance support.

• Inventory Management: Maintain safety stock levels aligned with production schedules to buffer against supply chain interruptions.

Quality Control and Testing Protocols

Implement rigorous testing standards upon receipt of API batches, including:

• Assay and Purity Tests: Confirm active ingredient content and impurity profiles via HPLC, GC, or other validated methods.

• Residual Solvent Analysis: Ensure residual solvents are within permissible limits (e.g., ICH Q3C guidelines).

• Microbial Testing: Verify absence of microbial contamination, especially for APIs used in oral formulations.

Future Trends and Industry Outlook

The API manufacturing landscape for brompheniramine maleate is influenced by increasing regulatory stringency, geopolitical shifts, and the demand for cost-effective generics. The trend toward APIs manufactured in regions with advanced quality oversight (e.g., India, Europe) is expected to continue. Additionally, rising emphasis on supply chain transparency and sustainability is shaping procurement strategies, with companies favoring vendors with demonstrated compliance and environmental responsibility.

Key Challenges

• Regulatory barriers in certain markets can limit supplier options.

• Variability in quality standards across geographies requires diligent oversight.

• Supply chain disruptions, especially during global crises (e.g., COVID-19), impact API availability.

Conclusion

The sourcing of brompheniramine maleate API demands a strategic approach anchored in quality assurance, regulatory compliance, and supply chain resilience. Indian and Chinese manufacturers dominate the landscape, offering a broad spectrum of options. However, rigorous qualification processes and supplier audits are essential to ensure consistent quality and regulatory adherence. As the pharmaceutical industry evolves, maintaining diversified supplier relationships and rigorous quality controls will underpin stable brompheniramine maleate supply chains.

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Key Takeaways

• India and China lead global production of brompheniramine maleate API, with suppliers like Aarti Drugs and Zhejiang Chenxin prominent in the space.

• Regulatory compliance, including GMP certifications, is critical when selecting API suppliers for international markets.

• Diversifying sources reduces supply risks; ongoing supplier qualification and audits safeguard quality and continuity.

• Implementing strict quality control protocols upon receipt ensures API compliance with specifications.

• Industry trends favor suppliers with transparent supply chains, robust quality systems, and sustainability commitments.

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FAQs

1. What are the primary manufacturing regions for brompheniramine maleate API?
India and China are the primary manufacturing hubs, offering large-scale production and cost advantages, with European suppliers providing high-regulatory-standard APIs.

2. How can I verify the quality of brompheniramine maleate API from a supplier?
Review their GMP certification, request comprehensive Certificates of Analysis, and conduct in-house or third-party testing for assay, impurities, residual solvents, and microbial contamination.

3. What regulatory considerations should be taken into account when sourcing brompheniramine maleate API?
Ensure the supplier holds GMP certifications compatible with your target markets, and verify their documentation supports regulatory submissions in jurisdictions like the US, EU, or Japan.

4. How does geopolitical stability impact API sourcing for brompheniramine maleate?
It influences supplier reliability and supply continuity, emphasizing the importance of having multiple qualified sources across different regions.

5. What future industry trends are expected to influence the brompheniramine maleate API supply chain?
Growing regulatory stringency, supply chain transparency initiatives, and demand for sustainable manufacturing practices are shaping sourcing strategies and supplier selection.

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References

[1] World Health Organization. WHO Good Manufacturing Practices (GMP) for Pharmaceutical Products. 2019.
[2] U.S. Food and Drug Administration. Guidance for Industry: Quality Systems Approach to Pharmaceutical Quality Control. 2020.
[3] International Council for Harmonisation. Q3C Impurities: Residual Solvent Guidelines. 2021.
[4] IQVIA Institute. Global API Market Trends. 2022.
[5] PharmSource. Global API Supplier Directory. 2023.