Bulk Pharmaceutical API Sources for THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER

Bulk Pharmaceutical API Sources for THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER

Vendor	Vendor Homepage	Vendor Sku	API Url
Hangzhou APIChem Technology		AC-12160
ABI Chem		AC1L3LQJ
Ambinter		T1505
ChemMol		30101964
TimTec		ST50411853

Bulk Active Pharmaceutical Ingredient (API) Sources for Theophylline 0.2% and Dextrose 5% in Plastic Container

Last updated: August 8, 2025

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Introduction

In pharmaceutical manufacturing, sourcing high-quality APIs is fundamental to ensuring the safety, efficacy, and regulatory compliance of parenteral formulations like Theophylline 0.2% and Dextrose 5% solutions in plastic containers. These compounded solutions are essential for various clinical indications, including management of chronic obstructive pulmonary disease (COPD), asthma, and as nutritional supplements. This article evaluates the primary sources for bulk APIs—Theophylline and Dextrose—focusing on global suppliers, validation standards, and quality assurance measures to guide industry professionals in procurement strategies.

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Overview of API Requirements

Theophylline (0.2%): A bronchodilator methylxanthine derivative used in respiratory therapy. It requires strict control over purity levels, residual solvent content, and sterility for injectable formulations.

Dextrose (5%): A sterile glucose solution, widely used as a volume expander and nutritional supplement, demanding rigorous sterility assurance and endotoxin control.

Both APIs must meet pharmacopeial standards (USP, Ph Eur, JP) and adhere to Good Manufacturing Practice (GMP) regulations for injectable and infusion-grade materials.

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Global API Manufacturers and Suppliers

1. Established API Manufacturers

a. Pfizer Inc.

• Profile: Globally recognized for producing high-purity APIs, including Theophylline.
• Capabilities: Offers bulk Theophylline APIs meeting USP and other pharmacopeial standards.
• Quality Assurance: Strict adherence to cGMP, extensive quality control, and validated international supply chains.

b. Jiangsu Hengrui Medicine Co., Ltd.

• Profile: Leading Chinese pharmaceutical manufacturer with significant API production capacity.
• Specialty: Produces Theophylline with documentation compliant to international standards.
• Validation: Possesses multiple GMP certifications and has supplied APIs for export and large-scale parenteral formulations.

c. Sanofi

• Profile: Diversified global pharmaceutical firm with a robust API manufacturing segment.
• API Portfolio: Includes Theophylline, with supply agreements for sterile, high-quality APIs suitable for injection.

d. Roquette Frères

• Profile: French company specializing in carbohydrate APIs.
• Dextrose Production: Offers pharmaceutical-grade Dextrose Monohydrate and solutions suitable for infusion.

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2. Contract Manufacturing and Exporters

a. Zhejiang Hisun Pharmaceutical Co., Ltd.

• Profile: Chinese manufacturer with proven capacity for bulk APIs, including Theophylline.
• Standards: Supplies APIs compliant with international pharmacopeias.

b. Synthesis and API Exporters in India

• Soma Pharmaceuticals, Biological E Limited, and Strides Pharma Science are notable for bulk API manufacturing and global API exports, including glucose derivatives.

c. Phot Pharma and Others

• Source APIs from trusted APIs suppliers with validated manufacturing facilities, aligned with global safety standards.

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Quality and Regulatory Considerations

• Compliance: Suppliers must provide Certificates of Analysis (CoA), Reference Standards, and Stability Data confirming compliance with USP, EP, or JP standards.

• GMP Certification: Verify certifications from respective regulatory agencies (FDA, EMA, NMPA, etc.).

• Sterility & Endotoxin Testing: Especially critical for Theophylline injections and Dextrose solutions.

• Supply Chain Security: Choose suppliers with validated logistics networks ensuring traceability and minimal contamination risks.

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Emerging Trends and Sources

Biopharmaceutical & Custom API Producers:

• Emergence of API manufacturers specializing in custom synthesis and biosynthetic APIs offers tailored solutions for niche formulations, including controlled-release Theophylline variants.

API Marketplaces:

• Platforms such as PharmSource and Alibaba facilitate supplier vetting, though due diligence and prior validation are paramount.

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Procurement Strategies

• Due Diligence: Conduct comprehensive audits, review GMP certificates, and procurement history.
• Supplier Qualification: Establish long-term relationships with verified, high-quality API suppliers.
• Risk Assessment: Evaluate geopolitical, regulatory, and logistical risks, especially for import-dependent APIs.

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Conclusion

Reliable sourcing of Theophylline 0.2% and Dextrose 5% APIs necessitates engagement with validated, GMP-certified manufacturers globally. Leading companies like Pfizer, Jiangsu Hengrui, and Sanofi provide high-quality bulk APIs suited for infusion formulations. Supplementing with reputable contract manufacturers ensures supply stability. Rigorous quality assurance and compliance with international pharmacopeial standards underpin successful procurement, ensuring safety and efficacy in parenteral applications.

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Key Takeaways

• Prioritize GMP-certified suppliers with proven documentation for Theophylline and Dextrose APIs.
• Cross-verify Certificates of Analysis, stability data, and regulatory compliance before sourcing.
• Leverage global manufacturers with extensive export capabilities, especially in China, India, and Europe.
• Maintain supplier qualification programs to mitigate risks associated with supply chain disruptions.
• Stay abreast of emerging API producers specializing in niche or customized pharmaceutical APIs.

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FAQs

1. What are the primary considerations when sourcing Theophylline API for injectable use?
Ensuring API purity, sterility, endotoxin levels, compliance with pharmacopeial standards, and GMP certification are critical for injectable Theophylline. Validated manufacturing processes and comprehensive documentation underpin procurement decisions.

2. How do I verify the quality of Dextrose 5% API sources?
Request detailed Certificates of Analysis, verify sterility and endotoxin testing reports, confirm compliance with pharmacopeial standards, and review manufacturer GMP certifications.

3. Which regions are leading producers of pharmaceutical-grade APIs?
China, India, and Europe are primary regions with established API manufacturing facilities. China and India account for a significant share of global API exports due to cost efficiencies and manufacturing scale.

4. What are potential risks associated with API sourcing?
Risks include supply chain disruptions, regulatory non-compliance, contamination issues, and counterfeit products. Implementing rigorous supplier qualification and audits mitigates these risks.

5. Are there specialty API suppliers for customized Theophylline formulations?
Yes, several contract API manufacturers offer custom synthesis tailored to specific formulation needs, including controlled-release or modified APIs, often within regulatory compliance frameworks.

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References

[1] U.S. Pharmacopeia, "Theophylline Monograph," USP-NF.
[2] European Pharmacopoeia, "Dextrose Monographs," Ph. Eur.
[3] Global API Manufacturers Directory, Pharmaceutical Technology.
[4] Sourcing Guidelines for APIs, WHO, "Good Manufacturing Practices," 2020.
[5] Market analysis reports, "Global API Market Size & Trends," IQVIA, 2022.