Bulk Pharmaceutical API Sources for buclizine hydrochloride

Bulk Pharmaceutical API Sources for buclizine hydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		65463
ABI Chem		AC1L23AJ
BioChemPartner		BCP0726000050

Bulk Active Pharmaceutical Ingredient (API) Sources for: Buclizine Hydrochloride

Last updated: August 2, 2025

Introduction

Buclizine Hydrochloride, an antihistamine and antiemetic agent primarily employed to manage nausea, vomiting, and motion sickness, has garnered significant interest in the pharmaceutical supply chain. As a piperazine derivative, its efficacy relies heavily on the quality and consistency of its Active Pharmaceutical Ingredient (API). Ensuring access to reputable bulk API sources is critical for pharmaceutical manufacturers, contract manufacturing organizations (CMOs), and generic drug companies seeking to produce buclizine hydrochloride at scale. This report provides a comprehensive overview of primary API suppliers, delineates the characteristics and considerations for sourcing, and offers strategic insights into market dynamics.

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Understanding Buclizine Hydrochloride as an API

Buclizine Hydrochloride's chemical formula is C₂₃H₂₉ClN₂O, with a molecular weight approximately 380.9 g/mol. It functions by blocking histamine H1-receptors, exerting antiemetic effects, particularly in motion sickness and vertigo management. Its synthesis involves complex chemical processes, emphasizing the importance of high-quality raw materials and manufacturing expertise.

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Key Criteria in API Sourcing

Successful procurement of buclizine hydrochloride API hinges on several parameters:

• Regulatory Compliance: Suppliers must adhere to Good Manufacturing Practices (GMP) and possess relevant certifications, such as ISO, Certificate of Suitability (CEP), or Drug Master File (DMF) status.

• Quality Specification: Robust characterization, high purity (>99%), low residual solvents, and absence of heavy metals are vital.

• Supply Stability: Consistent production capacity and lead times are essential to meet demand cycles.

• Pricing and Terms: Competitive pricing, flexible payment terms, and supply agreements help foster long-term partnerships.

• Documentation: Comprehensive documentation including Certificates of Analysis (CoA), batch records, and stability data.

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Major API Suppliers for Buclizine Hydrochloride

1. Chinese API Manufacturers

China remains a dominant player globally in bulk pharmaceutical ingredient production, owing to manufacturing scale, cost advantages, and ongoing regulatory improvements.

• Zhejiang Gongdong Medical Biotechnology Co., Ltd.
  Focuses on antihistamines and antiemetics; produces buclizine hydrochloride compliant with international standards. Certified with ISO and GMP; supplies globally.

• Hunan NutraMax Inc.
  Offers a range of APIs including buclizine hydrochloride, emphasizing high purity and consistent quality with comprehensive documentation.

• Sichuan Med-Shine Pharmaceutical Co., Ltd.
  Provides bulk APIs with competitive pricing; extensively exported to Europe, North America, and Asia.

2. Indian API Producers

India's pharmaceutical industry boasts a mature API manufacturing sector with stringent regulatory oversight, especially for exports.

• Divi's Laboratories
  Renowned for high-quality APIs across diverse therapeutic categories; holds GMP and WHO-GMP certifications, with an established track record in antihistamines.

• Biological E. Limited
  Focuses on generics and active ingredients, including buclizine hydrochloride, adhering to strict quality standards.

• Hetero Labs Ltd.
  Supplies a broad portfolio of APIs; maintains GMP certification and complies with international quality benchmarks.

3. European and North American Suppliers

While limited, a handful of specialty manufacturers and traders serve these markets with strict regulatory accreditation.

• CordenPharma (Germany)
  Provides high-grade APIs with a focus on clinical and commercial manufacturing. Holds extensive regulatory dossiers.

• Famar Healthcare Services (Greece)
  Offers APIs compliant with European pharmacopoeia standards; suitable for regulated markets.

• CMO Networks and Distributors
  Certain specialized traders and brokers facilitate procurement from manufacturers compliant with international standards for global distribution.

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Emerging Supply Chains and Market Dynamics

Global API sourcing for buclizine hydrochloride faces evolving challenges and opportunities:

• Regulatory Harmonization: Increased emphasis on WHO-GMP, US FDA, and EMA compliance has prompted suppliers to upgrade facilities.

• Trade Tariffs and Logistics: Geopolitical shifts and supply chain disruptions influence sourcing strategies; diversification becomes essential.

• Quality Assurance: Market consolidation favors suppliers with proven quality records, reinforcing the importance of audits and certificates.

• Cost Considerations: Chinese suppliers often offer competitive rates; however, regulatory requirements and import restrictions may influence procurement planning.

• Sustainability and Traceability: Growing demand for transparent supply chains emphasizes ethical sourcing and eco-friendly manufacturing.

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Strategic Considerations for Pharmaceutical Companies

• Supplier Qualification: Conduct comprehensive audits and request detailed documentation to verify quality and compliance.

• Diversification: Avoid over-reliance on single-source providers; establish multiple supplier relationships across regions.

• Long-term Agreements: Secure supply through contracts that stipulate quality standards, lead times, and pricing.

• Regulatory Due Diligence: Ensure suppliers possess appropriate certifications and can provide necessary dossiers for regulatory submissions.

• Pricing Strategies: Engage in negotiations considering not only cost but also supply security and quality assurances.

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Conclusion

The procurement landscape for buclizine hydrochloride API is characterized by significant regional variability, regulatory complexities, and quality considerations. Chinese and Indian manufacturers dominate the market owing to scale and cost competitiveness, with European and North American suppliers serving niche or highly regulated needs. Strategic sourcing requires rigorous supplier evaluation, compliance verification, and supply chain diversification to ensure uninterrupted pharmaceutical production.

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Key Takeaways

• Leading API suppliers for buclizine hydrochloride are predominantly based in China and India, offering cost-effective and compliant products.
• Regulatory compliance (GMP, ISO, CEP) remains paramount; suppliers with comprehensive documentation and proven audits are preferred.
• Supply chain diversification mitigates risks associated with geopolitics, tariffs, and logistical disruptions.
• Thorough qualification processes, including quality audits and document verification, are essential before onboarding new suppliers.
• Emerging market trends favor suppliers with transparent traceability, sustainable practices, and ability to meet evolving international standards.

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FAQs

1. What are the primary regulatory considerations when sourcing buclizine hydrochloride API?
   Ensuring suppliers hold certified GMP compliance, appropriate certifications (CEPs, DMFs), and robust quality management systems is critical to meet regulatory requirements in global markets.

2. Which regions dominate the manufacture of buclizine hydrochloride API?
   China and India are the leading regions due to their extensive pharmaceutical manufacturing infrastructure and cost advantages.

3. How can companies verify the quality of buclizine hydrochloride APIs from new suppliers?
   Conduct comprehensive audits, review Certificates of Analysis, request stability data, and perform independent quality testing where feasible.

4. Are there notable differences in API quality between manufacturers?
   Yes, differences can exist based on process control, purification methods, and adherence to quality standards. Choosing suppliers with international certifications reduces variability.

5. What factors influence the pricing of buclizine hydrochloride API?
   Production costs, raw material availability, regulatory complexity, supply chain logistics, and market demand all impact pricing.

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References

1. [1] U.S. FDA, "Active Pharmaceutical Ingredient (API) Foreign Supplier Verification Program," FDA.gov.
2. [2] WHO, "Guidelines on Good Manufacturing Practices," WHO.int.
3. [3] Chemistry and Manufacturing Data, Zhejiang Gongdong Medical Biotechnology Co., Ltd.
4. [4] "API Market Analysis for Antihistamines," GlobalData Reports.
5. [5] "Sourcing Strategies for APIs," PharmSource Industry Reports.

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Note: Data and supplier specifics are for informational purposes. Prospective buyers should conduct due diligence and verify current compliance status.