Bulk Pharmaceutical API Sources for TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE

Bulk Pharmaceutical API Sources for TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		5577
ABI Chem		AC1L1KNN
ChemMol		49415933
AKos Consulting & Solutions		AKOS007167113
Chembase.cn		544
Mcule		MCULE-6926505112
A&J Pharmtech CO., LTD.		AJ-23399

Bulk Active Pharmaceutical Ingredient (API) Sources for Trimethobenzamide Hydrochloride Preservative-Free

Last updated: August 11, 2025

Introduction

Trimethobenzamide hydrochloride (TBH) is a pharmaceutical compound primarily used as an antiemetic to treat nausea and vomiting. Its injectable or oral formulations require high-purity, preservative-free API to ensure safety, efficacy, and regulatory compliance—particularly vital in formulations administered via sensitive routes such as intramuscular or intravenous. As the demand for preservative-free APIs increases due to patient safety concerns and regulatory guidelines, identifying reliable bulk sources for trimethobenzamide hydrochloride becomes critical for pharmaceutical manufacturers.

This report provides a comprehensive overview of the global sources and suppliers capable of providing bulk quantities of preservative-free trimethobenzamide hydrochloride API, emphasizing quality standards, supply capacity, and geographic distribution.

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Regulatory and Quality Considerations

Regulatory approval: Suppliers must supply APIs that comply with Good Manufacturing Practice (GMP) standards, aligning with agencies such as the FDA (United States), EMA (European Union), and PMDA (Japan). For preservative-free APIs, stringent control of contaminants and impurities is essential.

Chemical purity: The API must meet pharmacopoeial standards—USP, EP, or JP—as applicable. The essential parameters include Assay (generally ≥98%), Related Substances, and Residue limits, notably ensuring no preservative residues.

Manufacturing capabilities: Suppliers should have expertise in synthesizing amides and related compounds, with documented processes for obtaining preservative-free APIs, minimizing chemical contaminants, and consistent batch-to-batch quality.

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Key Global Suppliers and Sources

1. Major Manufacturers in China

a. North China Pharmaceutical Group (NCPC)

• Capacity: Large-scale production with GMP certification.
• Offerings: Bulk trimethobenzamide hydrochloride, compliant with international standards.
• Strengths: Proven quality control, competitive pricing, and extensive export network.

b. North China Pharmaceutical Co., Ltd.

• Capabilities: Custom synthesis and bulk supply with emphasis on preservative-free APIs.
• Certifications: GMP, ISO 9001.

c. Zhejiang Hisoar Pharmaceutical

• Specialty: Synthesis of pharmaceutical intermediates and APIs.
• Focus: Preservative-free compounds with high purity.

Note: Chinese suppliers dominate global API export markets, approved by multiple regulatory agencies, with numerous GMP-certified plants.[1]

2. Indian API Manufacturers

a. Sun Pharmaceutical Industries Ltd.

• Capacity: Extensive API manufacturing network.
• API Focus: Many antiemetics and central nervous system drugs, including trimethobenzamide hydrochloride, with GMP compliance.

b. Aarti Drugs Ltd.

• Capabilities: Bulk API production tailored to global standards.
• Highlights: Emphasis on preservative-free formulations with robust quality systems.

c. Jubilant Life Sciences

• Offerings: Synthesis and supply of complex APIs, including specialty amides.

Note: India’s API sector is heavily regulated, with strict adherence to GMP, making these sources suitable for preservative-free API sourcing.[2]

3. European and North American Suppliers

a. Fagron Compounding Resources

• Focus: High-quality pharmaceutical ingredients, including preservative-free APIs.
• Capabilities: Custom synthesis and large-volume sourcing for pharmaceuticals.

b. TCI America

• Role: Distributes APIs and chemical intermediates, including specialty amides, with verified quality standards.

c. Camargo Pharmaceutical Services

• Capabilities: Sourcing and manufacturing of high-purity APIs with compliance to US and EU standards.

Note: European and North American API manufacturers often cater to niche markets requiring rigorous purity and preservative-free standards, though at higher costs.[3]

4. Contract Development and Manufacturing Organizations (CDMOs)

Many CDMOs offer bespoke API synthesis, including preservatives removal or avoidance, and can scale from clinical supplies to commercial batches.

a. Lonza

• Specialty: Customized API manufacturing, including amides and pharmaceutical intermediates.

b. PCAS Group

• Focus: Advanced chemical synthesis with strict quality control for preservative-free APIs.

c. Siegfried Holding AG

• Capabilities: Integrated synthesis, purification, and packaging of APIs adhering to global regulatory standards.

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Considerations for Sourcing Preservative-Free API

• Purity and Certification: Confirm ISO certifications (such as ISO 9001), cGMP compliance, and independent testing results confirming preservative-free status.
• Supply Chain Stability: Ensure supplier’s production capacity can accommodate demand fluctuations.
• Regulatory Documentation: Verify presence of CROs or Quality Agreements, and ability to provide Batch Certification, COA, and stability data suitable for regulatory submissions.
• Red Flags: Beware of suppliers with inconsistent quality controls, inadequate documentation, or those lacking exposure to stringent pharmaceutical manufacturing practices.

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Emerging and Niche Suppliers

As the pharmaceutical industry increasingly emphasizes preservative-free formulations, emerging biotech and chemical companies in Asia-Pacific regions are investing in dedicated production lines for APIs like trimethobenzamide hydrochloride. These newer entrants often offer competitive pricing and customization but require rigorous auditing to verify manufacturing standards.

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Conclusion

Selecting a reliable, quality-centric bulk API supplier for preservative-free trimethobenzamide hydrochloride involves evaluating manufacturers’ regulatory compliance, manufacturing capacity, and quality assurance. Chinese and Indian suppliers dominate global supply chains, supported by their extensive GMP-certified facilities and cost advantages. European and North American suppliers offer high-end, ultra-pure APIs suited for sensitive clinical and sterile formulations. Engaging with established CDMOs offers additional flexibility for custom synthesis of preservative-free APIs, essential for specialized pharmaceutical applications.

To ensure uninterrupted supply and compliance, pharmaceutical companies must perform due diligence, including site audits, review of regulatory certifications, and comprehensive quality agreements.

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Key Takeaways

• The growing demand for preservative-free APIs elevates the importance of sourcing from GMP-certified, high-quality manufacturers.
• Chinese and Indian suppliers lead global API exports, with many offering preservative-free trimethobenzamide hydrochloride capable of meeting international standards.
• European and North American sources emphasize ultra-purity and stringent compliance, suitable for sensitive formulations.
• Contract manufacturing organizations provide tailored synthesis options with quality assurance suitable for regulatory filings.
• Due diligence—including audits, certification verification, and stability data review—is vital to mitigate supply and quality risks.

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FAQs

1. What are the primary considerations when sourcing preservative-free trimethobenzamide hydrochloride API?
The key factors include GMP certification, chemical purity, absence of preservatives, supply stability, regulatory compliance, and comprehensive documentation such as COA and stability data.

2. Are Chinese suppliers reliable for preservative-free trimethobenzamide hydrochloride?
Yes. Many Chinese API manufacturers operate under GMP and ISO standards, offering high-quality, preservative-free APIs. Due diligence and audits are recommended to verify compliance.

3. How can I verify that an API is preservative-free?
Request detailed analytical reports, including impurity profiles, residual preservative testing (e.g., benzyl alcohol), and supplier certifications. Independent testing can confirm preservative absence.

4. What are the challenges associated with sourcing from emerging suppliers?
Risks include inconsistent quality control, lack of regulatory approvals, limited capacity, and potential supply chain disruptions. Performing rigorous qualification audits mitigates these issues.

5. Is it more costly to source APIs from European or North American suppliers?
Typically, yes. Higher production costs and stringent regulatory standards contribute to increased pricing, but they often provide higher assurance of purity and compliance.

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References

1. [1] U.S. Food and Drug Administration (FDA). GMP Regulations and Guidance.
2. [2] India Ministry of Chemicals and Fertilizers. API manufacturing standards and guidelines.
3. [3] European Pharmacopoeia. Standards for high-purity APIs.