Bulk Pharmaceutical API Sources for DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		H8502_SIGMA
Ambinter		BB_NC-1356
Calbiochem		4000
HDH Pharma		IN1467
NovoSeek		65340
MP Biomedicals		101580

Bulk Active Pharmaceutical Ingredient (API) Sources for Dopamine Hydrochloride and Dextrose 5% in Plastic Container

Last updated: August 10, 2025

Introduction

The pharmaceutical industry's reliance on high-quality API sourcing is pivotal for ensuring safety, efficacy, and regulatory compliance of injectable drugs such as Dopamine Hydrochloride and Dextrose 5%. Both APIs serve vital roles in clinical settings: Dopamine Hydrochloride functions as a vasopressor and inotropic agent, while Dextrose 5% solutions are essential for fluid and carbohydrate replacement. Their combination in plastic containers facilitates broad use in hospitals and clinics. Identifying reliable bulk API sources demands rigorous scrutiny to align with regulatory standards, confirm purity, and ensure consistent supply chains.

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Overview of Dopamine Hydrochloride and Dextrose 5%

Dopamine Hydrochloride

Dopamine Hydrochloride (C8H11NO2·HCl) is a sympathomimetic catecholamine used intravenously to treat shock and hypotension. Its pharmacological activity stems from stimulating dopaminergic and beta-adrenergic receptors, optimizing cardiac output and renal perfusion. The API's production demands precise control of stereochemistry, purity, and stability.

Dextrose 5% in Plastic Container

Dextrose 5% (D-glucose in water) solutions are isotonic, providing essential calories and serving as a diluent in injectable medications. Packaging in plastic (usually polyethylene or polypropylene) containers minimizes contamination and facilitates large-volume infusion, aligning with hospital sterile drug administration protocols.

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Global API Market for Dopamine Hydrochloride

Leading Suppliers

1. Fresenius Kabi (Germany): A premier provider of injectable APIs, including Dopamine Hydrochloride. They maintain strict cGMP compliance and have robust quality assurance protocols aligned with EMA and FDA standards. Their production facilities are certified under ICH Q7 guidelines, ensuring high purity APIs for global markets.

2. Mundipharma (Germany): Recognized for their high-quality small-molecule APIs, Mundipharma supplies Dopamine Hydrochloride with a focus on pharmaceutical-grade standards. Their manufacturing process emphasizes controlled synthesis and stringent testing.

3. F – Hoffmann-La Roche Ltd. (Switzerland): A historic leader in pharmaceutical manufacturing, Roche offers Dopamine API in bulk, leveraging advanced synthetic methods to ensure high potency and minimal impurities.

4. Viva Biotech (China): Emerging API manufacturer with certifications from CFDA and international regulatory bodies, Viva Biotech supplies Dopamine Hydrochloride for bulk use, emphasizing cost-effective production without compromising quality.

Regional and Specialty Suppliers

• Aenova Group (Germany): Known for integrating API sourcing with finished drug manufacturing, Aenova partners with licensed API producers to secure Dopamine suitable for injectable formulations.
• Hanmi Pharmaceutical (South Korea): Focuses on high purity APIs, including Dopamine Hydrochloride, with capacity to meet international standards.

Regulatory & Certification Standards

Top-tier suppliers adhere to:

• Current Good Manufacturing Practices (cGMP)
• International Conference on Harmonisation (ICH) Q7 guidelines
• EMA, FDA, and WHO approvals

Supply Chain Considerations

• Consistent batch-to-batch quality
• Traceability and documentation
• Supply reliability amid geopolitical and economic shifts

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Global API Market for Dextrose 5%

Major Suppliers

1. Cargill, Inc. (USA/Global): A leading global supplier of pharmaceutical-grade Dextrose Monohydrate, which is used for preparations like Dextrose 5%. They meet stringent pharmaceutical quality standards and have extensive logistics networks.

2. Fusong East Long Chemical Co., Ltd. (China): Specializes in food and pharmaceutical-grade glucose, including Dextrose 5%, with certifications aligning with USP, EP, and JP standards.

3. Roquette Frères (France): Offers high-purity Dextrose Monohydrate conforming to pharmacopeial standards, suitable for injection solutions in plastic containers.

4. Harima Chemicals Group (Japan): Known for high-quality carbohydrate APIs, supplying Dextrose to pharmaceutical manufacturers worldwide.

Regional Providers

• Tereos (France): Supplies surgical-grade Dextrose, with extensive quality controls.
• Shandong Jianyuan Food Co., Ltd. (China): Concentrates on pharmaceutical-grade Dextrose, with exports compliant with international standards.

Quality Compliance

• Certification of analysis (COA)
• Compliance with USP, EP, JP, and other pharmacopeial monographs
• Validation of endotoxin levels and microbial limits

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Key Factors for Sourcing Bulk APIs

1. Regulatory Certification and Compliance: Ensure suppliers have FDA, EMA, or other relevant certifications, with documentation demonstrating adherence to cGMP and ICH guidelines.

2. Purity and Impurity Profile: Confirm that APIs meet pharmacopoeial standards for assay, residual solvents, heavy metals, endotoxins, and microbial contamination.

3. Supply Chain Robustness: Evaluate supplier capacity for consistent supply volume, contingency protocols, and transparent traceability.

4. Pricing and Lead Times: Balance quality with cost efficiency, factoring in logistics, tariffs, and delivery timelines.

5. Quality Control and Batch Testing: Request detailed COA, including results of HPLC, IR, NMR, and other analytical methods to verify purity.

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Conclusion

Selecting reputable bulk API sources for Dopamine Hydrochloride and Dextrose 5% in plastic containers demands rigorous due diligence. Leading European and Asian manufacturers dominate the supply landscape—each adhering to international quality standards and possessing robust regulatory certifications. An emphasis on supply chain resilience, comprehensive quality assurance, and compliance with pharmacopoeial monographs ensures reliable procurement for pharmaceutical manufacturers and clinicians.

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Key Takeaways

• Regulatory compliance is paramount: Select suppliers compliant with USP, EP, JP, FDA, and EMA standards, with documented certifications.
• Quality assurance drives safety: Ensure high purity, low impurity profiles, and minimal endotoxins for APIs intended for injectable formulations.
• Global manufacturers are viable options: Leading companies from Europe, North America, and Asia provide high-quality Dopamine Hydrochloride and Dextrose 5% APIs.
• Supply chain stability matters: Engage suppliers with proven logistics, capacity, and contingency planning.
• Due diligence is essential: Confirm batch-specific COAs, quality control results, and regulatory recognition before procurement.

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FAQs

1. What are the globally recognized certifications for API suppliers?

Key certifications include cGMP compliance, FDA registration, EMA approval, ISO certifications, and pharmacopoeial compliance (USP, EP, JP). These affirm manufacturing quality and regulatory adherence.

2. How do I verify the purity of bulk Dopamine Hydrochloride or Dextrose 5% APIs?

Request comprehensive Certificates of Analysis (COA) detailing HPLC, microbial limits, endotoxin levels, residual solvents, heavy metals, and stereochemical purity, verified through standardized testing methods.

3. Which regions dominate the supply of pharmaceutical-grade Dopamine and Dextrose APIs?

Europe (Germany, Switzerland), North America (USA), and Asia (China, South Korea, Japan) are leading regions, with established manufacturing and quality assurance practices.

4. What are the critical quality attributes to consider when sourcing these APIs?

Purity (>99%), low levels of impurities, endotoxin levels compatible with injectable use, stability profiles, and compliance with pharmacopeial standards are essential quality attributes.

5. How does supply chain risk affect API procurement?

Supply chain disruptions can lead to shortages, quality inconsistencies, or regulatory compliance issues. Establishing relationships with multiple certified suppliers and maintaining inventory buffers mitigates these risks.

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References

1. [1]. European Pharmacopoeia (EP). "Dopamine Hydrochloride." European Directorate for the Quality of Medicines & HealthCare.
2. [2]. United States Pharmacopeia (USP). "Dextrose Monohydrate." USP-NF Monographs.
3. [3]. FDA's Guidance for Industry. "API Manufacturing," U.S. Food and Drug Administration, 2022.
4. [4]. ICH Q7. Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.
5. [5]. WHO Guidelines on Good Manufacturing Practices for Active Pharmaceutical Ingredients.

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This comprehensive analysis positions pharmaceutical manufacturers and procurement professionals to make informed, strategic sourcing decisions for Dopamine Hydrochloride and Dextrose 5% APIs, emphasizing quality, regulatory compliance, and supply security.