Bulk Pharmaceutical API Sources for CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
ABI Chem		AC1L9EKE
ChemMol		2101413
CAPOT		PubChem5913
AKos Consulting & Solutions		AKOS008901431
CAPOT		5913
Chembase.cn		73280
AK Scientific, Inc. (AKSCI)		70534

Bulk Active Pharmaceutical Ingredient (API) Sources for Clindamycin Phosphate in Dextrose 5% in Plastic Container

Last updated: August 2, 2025

Introduction

The procurement of high-quality bulk Active Pharmaceutical Ingredients (APIs) is pivotal for pharmaceutical manufacturing, ensuring efficacy, safety, and regulatory compliance. Clindamycin phosphate (CP), a broad-spectrum lincosamide antibiotic, is frequently supplied as a sterile, injectable formulation in dextrose 5% (D5W) within plastic containers. Identifying reliable sources for bulk CP APIs in this specific formulation is essential for manufacturers seeking to establish a consistent supply chain, optimize costs, and maintain product quality.

Understanding Clindamycin Phosphate in Dextrose 5%

Clindamycin phosphate is water-soluble, typically supplied as a sterile, ready-to-use solution. When formulated in dextrose 5%, it offers an isotonic solution suitable for intravenous administration. The API needs to meet rigorous pharmaceutical standards, including compendial purity, sterility, endotoxin limits, and stability in solution.

Global API Suppliers for Clindamycin Phosphate in Dextrose 5%

Several pharmaceutical and biopharmaceutical companies worldwide manufacture and supply bulk clindamycin phosphate suitable for formulations in D5W. The key criteria for selection include GMP compliance, production capacity, regulatory approvals, and quality consistency.

1. Major Global API Manufacturers

A. Zhejiang Huazhong Pharmaceutical Co., Ltd. (China)

• Overview: Recognized for producing a broad range of antibiotics, including lincomycin derivatives.
• API Focus: Offers GMP-certified manufacturing of clindamycin phosphate bulk API.
• Standout Features: High purity levels, consistent supply, and compliance with international standards.
• Certifications: CE, ISO, and applicable regulatory certificates.

B. AMC in the United States

• Overview: American manufacturer with a focus on sterile injectable APIs.
• API Focus: Supplies GMP-grade clindamycin phosphate for hospital and institutional use.
• Features: Emphasizes rigorous quality control, endotoxin testing, and sterile processing.
• Certifications: FDA approved, cGMP certified.

C. Zhejiang Yuxi Pharmaceutical Co., Ltd. (China)

• Overview: Noted for supplying sterile antibiotics, including clindamycin phosphate.
• API Focus: Produces high-purity chemical APIs for parenteral formulations.
• Quality Assurance: Extensive quality validation procedures, stability testing.

D. Zhejiang Hisun Pharmaceutical Co., Ltd. (China)

• Overview: A major producer of systemic antibiotics, including clindamycin derivatives.
• API Features: Offers GMP-compliant bulk API suitable for injectable solutions.
• Regulatory Status: Approved for exports to Europe, North America, and other markets.

2. Regional API Suppliers

E. Sandoz (Novartis Group, Switzerland)

• Reputation: Known for sterile APIs and injectable formulations.
• API Portfolio: Offers clindamycin phosphate suitable for D5W formulations.
• Compliance: Adheres to strict EU and US GMP requirements.

F. Huadong Medicine (China)

• Specialties: Produces and supplies APIs, including antibiotics with strict quality controls.
• Supply Focus: Emphasizes quality and regulatory adherence for global markets.

3. Considerations for Selecting API Suppliers

• Regulatory Compliance: Confirm API manufacturing adheres to cGMP, with necessary certifications (e.g., FDA, EMA, China GMP).
• Quality Certificates: Seek API batches with strict endotoxin, sterility, and impurity profile testing results.
• Supply Stability: Evaluate supplier capacity for consistent bulk supply aligned with production demands.
• Documentation: Ensure comprehensive documentation (COA, batch records, stability data).
• Traceability: Preference for suppliers offering clear traceability and validated manufacturing processes.

4. Regulatory and Quality Aspects

For formulations intended for global markets, such as the US and Europe, API suppliers must comply with respective regulatory standards [1][2]. It ensures the API's safety profile for parenteral use, sterility, and compatibility within the plastic container system. Moreover, suppliers need to provide stability data for the API in Dextrose 5% solutions, confirming the API’s stability and absence of degradation products over the product shelf life.

Conclusion

Choosing a reliable bulk API source for clindamycin phosphate in Dextrose 5% in plastic containers involves assessing regulatory compliance, product quality, manufacturing capacity, and supply security. The global landscape features multiple reputable manufacturers, predominantly based in China, the US, and Switzerland, with established track records in sterile pharmaceutical APIs. For ongoing supply, establishing formal agreements, conducting due diligence, and qualifying suppliers through audits or validation batches are recommended best practices.

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Key Takeaways

• Numerous recognized manufacturers supply high-quality, GMP-compliant bulk clindamycin phosphate suitable for Dextrose 5% formulations.
• Chinese suppliers, such as Zhejiang Huazhong and Zhejiang Yuxi, dominate the manufacturing landscape with competitive quality and pricing.
• US-based companies like AMC provide sterile, high-purity APIs compliant with stringent North American standards.
• Selection criteria include regulatory compliance, quality assurance, traceability, and supply reliability.
• Ensuring compatibility with plastic container systems requires APIs with validated stability data in D5W.

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FAQs

1. What are the primary considerations when sourcing bulk API for sterile injectable formulations?
Manufacturers must prioritize GMP compliance, sterility assurance, endotoxin limits, impurity profiles, consistent potency, and stability data specific to the formulation in question.

2. Why is regulatory certification critical for API suppliers?
Regulatory certifications such as FDA, EMA, or China GMP ensure the API meets safety, efficacy, and quality standards necessary for pharmaceutical use, facilitating approval in target markets.

3. Are Chinese API suppliers reliable for pharmaceutical formulations?
Yes. Many Chinese API manufacturers adhere to internationally recognized GMP standards and have gained approval from global regulatory agencies; audits and supplier qualification are recommended.

4. How does the API's stability in Dextrose 5% influence sourcing decisions?
Stability data confirming no significant degradation or adverse reactions in D5W are essential for maintaining product efficacy and safety over shelf life, impacting supplier selection.

5. What challenges might arise when importing APIs for sterile formulations?
Potential challenges include regulatory variations, shipping and storage conditions affecting sterility, endotoxin control, and ensuring rigorous documentation and traceability compliance.

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References

[1] U.S. Food and Drug Administration (FDA). Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Data Integrity and Data Audit Trail. 2018.

[2] European Medicines Agency (EMA). Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials. 2021.