Bulk Pharmaceutical API Sources for ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-983-448
Hangzhou APIChem Technology		AC-12464
AKos Consulting & Solutions		AKOS015889292
CAPOT		17490
Finetech Industry Limited		FT-0659335
Synblock Inc		AB07046

Bulk Active Pharmaceutical Ingredient (API) Sources for Ondansetron Hydrochloride and Dextrose in Plastic Container

Last updated: August 5, 2025

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Introduction

The global pharmaceutical supply chain relies heavily on the sourcing of high-quality active pharmaceutical ingredients (APIs) to ensure the efficacy and safety of injectable formulations. Specifically, ondansetron hydrochloride—a potent antiemetic—and dextrose—a widely used carbohydrate source—are frequently combined in sterile solutions for various clinical applications. For medications packaged in plastic containers, identifying reliable, GMP-compliant API sources is critical. This overview examines the primary suppliers, manufacturing origins, and procurement considerations for bulk ondansetron hydrochloride and dextrose used in injectable formulations.

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Ondansetron Hydrochloride API Sources

Global Manufacturers and Supply Chain Dynamics

Ondansetron hydrochloride, a serotonin 5-HT3 receptor antagonist, is extensively manufactured worldwide, primarily sourced from major pharmaceutical companies with robust API manufacturing capabilities. The highest-quality APIs adhere to strict GMP standards, essential for parenteral formulations.

Key production regions include:

• India:
  India is a significant producer of ondansetron hydrochloride API, with companies such as Divi's Laboratories, Aurobindo Pharma, and Sun Pharma offering GMP-certified APIs. Indian manufacturers benefit from cost advantages and strict adherence to international quality standards, making them preferred suppliers for global markets.

• China:
  Several Chinese API manufacturers, including Zhejiang NHU and North China Pharmaceutical Group, supply ondansetron hydrochloride globally. These manufacturers have improved GMP compliance and quality control, supported by stringent export standards.

• Europe and the United States:
  While fewer APIs are produced domestically in Europe and the US, certain specialty chemical companies and CDMOs (Contract Development and Manufacturing Organizations) provide high-purity ondansetron hydrochloride, often sourced through tier-one suppliers or regional distributors.

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Leading Suppliers and Certifications

Most reputable suppliers for ondansetron hydrochloride API are certified under international standards such as:

• WHO-GMP (World Health Organization Good Manufacturing Practice)
• ISO certifications
• FDA-approved facilities (for US markets)
• EMA standards (European Medicines Agency)

Major API suppliers include:

• Divi’s Laboratories (India): Multiple GMP-certified APIs, including ondansetron hydrochloride.
• Aurobindo Pharma (India): Offers GMP-compliant APIs for global export.
• Hikal Ltd. (India): Supplies pharmaceutical grade ondansetron hydrochloride API.
• Zhejiang NHU (China): Known for large-scale API manufacturing with GMP certification.

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Procurement Considerations

• Quality Compliance: Ensure suppliers hold WHO-GMP or equivalent certifications. Confirm batch-to-batch consistency, residual solvents, heavy metals, and impurity profiles through Certificates of Analysis (CoA).
• Supply Reliability: Establish procurement agreements with suppliers demonstrating consistent delivery records, quality control, and capacity to meet demand fluctuations.
• Pricing and Lead Times: Indian and Chinese suppliers offer competitive pricing, but lead times and logistical considerations must be managed to prevent shortages.

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Dextrose API Sources

Global Production and Suppliers

Dextrose (D-glucose) used in injectable solutions is predominantly manufactured through enzymatic conversion processes from starch sources, like maize, corn, wheat, or cassava.

Key regions producing pharmaceutical-grade dextrose API:

• India:
  Leading producers such as Cargill India and Roquette India supply pharmaceutical-grade dextrose with international certifications.

• China:
  Multiple large-scale producers, including Shandong Xuyi Pharmaceutical and Guangxi Maoyuan Food Industry Co., Ltd., supply GMP-compliant dextrose API globally.

• Europe and North America:
  While primarily a food ingredient, GMP-compliant API-grade dextrose is available from specialized chemical suppliers such as Sigma-Aldrich (Merck) and Ajinomoto.

Manufacturing standards include good manufacturing practices, high purity specifications, and compliance with pharmacopeial standards such as USP, EP, and JP.

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Supplier Certification and Quality Standards

• Pharmaceutical-grade dextrose must meet pharmacopeial standards for residual contaminants, pH, and osmolality.
• GMP certification is essential for injectable use, ensuring stringent control over impurities and sterility.

Key Suppliers:

• Cargill and Roquette (India): Certified to GMP standards, with a history of supplying pharmaceutical-grade dextrose.
• Shandong Xuyi Pharmaceutical (China): Meets international pharmacopeial and GMP standards.
• Sigma-Aldrich (Global): Offers pharmaceutical-grade dextrose within a broad chemical product portfolio.

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Sourcing Challenges and Best Practices

• Traceability: Verify full supply chains to prevent adulteration or substandard ingredients—especially crucial given the vulnerability of injectable APIs.
• Quality Documentation: Demand comprehensive Certificates of Analysis, Stability Data, and Regulatory Documentation.
• Regulatory Compliance: Confirm supplier adherence to current Good Manufacturing Practices (cGMP), and ensure APIs are suitable for parenteral formulations that require high purity and low endotoxin levels.

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Conclusion

Sourcing bulk ondansetron hydrochloride and dextrose APIs efficiently demands strategic selection of GMP-certified suppliers with proven reliability, quality, and regulatory compliance. India and China remain dominant global sources for cost-effective APIs, supported by increasing international certifications and quality systems. Ensuring rigorous due diligence, quality control, and supply chain transparency is essential for pharmaceutical companies aiming to produce safe, effective injectable formulations in plastic containers.

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Key Takeaways

• Global sourcing is centered around India and China, with reputable suppliers offering GMP-certified APIs suitable for injectables.
• Rigorous compliance with GMP standards and pharmacopeial specifications is vital to meet safety and efficacy requirements.
• Establishing strong supplier relationships enhances supply reliability and quality consistency.
• Transparency in documentation—including Certificates of Analysis and stability data—reduces risks of contamination or non-compliance.
• Regulatory alignment and due diligence on manufacturing facilities streamline approval processes worldwide.

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FAQs

1. What are the main factors to consider when sourcing ondansetron hydrochloride API?
Critical factors include GMP compliance, certification standards, supplier reputation, quality consistency, lead times, and cost-effectiveness.

2. Can APIs from China and India be reliably used for injectable formulations?
Yes, numerous certified suppliers in these countries produce pharmaceutical-grade APIs that meet international standards when properly vetted and supported by thorough quality documentation.

3. How does dextrose API quality differ from food-grade to pharmaceutical-grade?
Pharmaceutical-grade dextrose undergoes stricter controls on residual impurities, endotoxins, and microbial contamination, making it suitable for injectable use, unlike food-grade dextrose.

4. Are there regional regulatory issues related to API sourcing from China and India?
While some markets may have additional validation or import requirements, many countries recognize GMP certifications from these regions, provided proper documentation and compliance are maintained.

5. What role do Certificates of Analysis (CoA) play in API procurement?
CoA provides detailed information on each batch’s purity, contaminants, residual solvents, and compliance with regulatory standards, serving as a critical quality assurance document.

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Sources

[1] Divi’s Laboratories, "API manufacturing capabilities," 2022.
[2] Aurobindo Pharma, "GMP-certified APIs," 2022.
[3] Zhejiang NHU, "API production standards," 2022.
[4] European Directorate for the Quality of Medicines & HealthCare (EDQM), "Bulk API specifications," 2022.
[5] U.S. Food and Drug Administration (FDA), "API manufacturing guidelines," 2022.