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

Bulk Pharmaceutical API Sources for THEOPHYLLINE 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
IS Chemical Technology		I14-62379

Bulk API Sources for Theophylline and Dextrose 5% in Plastic Container

Last updated: August 19, 2025

Introduction

The pharmaceutical industry relies heavily on the global supply chain for bulk Active Pharmaceutical Ingredients (APIs). For intravenous (IV) formulations such as Theophylline and Dextrose 5%, sourcing high-quality APIs is critical to ensure product efficacy, safety, and regulatory compliance. As these APIs are delivered in plastic containers for IV administration, sourcing must also consider compatibility, stability, and regulatory standards.

This article examines the primary API sources for Theophylline and Dextrose 5%, focusing on their global manufacturers, regulatory status, and procurement considerations. It aims to guide pharmaceutical companies, procurement teams, and manufacturers in selecting reliable API suppliers aligned with quality standards and supply stability.

---

Theophylline API Sources

Overview of Theophylline

Theophylline is a bronchodilator used mainly in treating respiratory diseases such as asthma and COPD. Its API is classified as a methylxanthine alkaloid, with strict regulatory standards (e.g., USP, EP, JP, and other pharmacopeias).

Major Global Manufacturers of Theophylline API

1. Mitsubishi Tanabe Pharma Corporation (Japan)
   A prominent producer of methylxanthine APIs, Mitsubishi maintains high quality manufacturing standards compliant with international pharmacopeial requirements. Their API manufacturing facilities are GMP-certified, offering consistent batches suitable for high-volume IV formulations.

2. Siegfried AG (Switzerland)
   Siegfried specializes in custom synthesis and bulk APIs, including Theophylline. Their facilities comply with EU GMP standards, and they have extensive experience supplying APIs globally, including to the sterile injectable market.

3. Hikal Ltd. (India)
   Hikal is a leading Indian manufacturer of APIs, offering Theophylline with GMP certification. Their capacity to sustain large-scale production makes them a viable source for bulk API procurement.

4. Xinfa Pharmaceutical Group (China)
   A major Chinese API producer, Xinfa supplies Theophylline API to international markets. Their facilities adhere to cGMP standards, with a focus on quality control and consistent supply.

5. Mochida Pharmaceutical Co., Ltd. (Japan)
   Mochida has established a robust supply chain for methylxanthines, including Theophylline, with a strong emphasis on quality assurance and regulatory compliance.

Regulatory and Quality Considerations

• Suppliers certified under WHO-GMP, US FDA, EMA, or Japan PMDA standards reduce regulatory hurdles.
• API specifications must meet Ph. Eur., USP, or other relevant standards.
• Stability data and analytical methods should be provided to confirm suitability for IV formulations.

---

Dextrose 5% API Sources

Overview of Dextrose (Glucose) API

Dextrose (D-glucose) is a monosaccharide used extensively as an energy source in parenteral nutrition and hydration solutions. The API is primarily derived from cornstarch or maize and must meet rigorous quality and purity standards to ensure patient safety.

Key Global Suppliers of Dextrose API

1. Cargill, Inc. (USA)
   A leading supplier of pharmaceutical-grade dextrose, Cargill’s API is produced under strict GMP conditions, with a global supply chain capable of supporting large-scale IV product manufacturing.

2. Roquette Frères (France)
   Known for high-quality pharmaceutical excipients, Roquette supplies pharmaceutical-grade dextrose monohydrate, meeting pharmacopeial standards necessary for injectable use.

3. Tate & Lyle PLC (UK)
   Tate & Lyle’s pharmaceutical-grade glucose API is produced from non-GMO maize and adheres to international quality and safety standards, including certification for injectable applications.

4. Shandong Bairun Biological Co., Ltd. (China)
   Their dextrose API is produced in GMP-compliant facilities, offering cost-effective sourcing options for large bulk requirements.

5. Harbin Pharmaceutical Group (China)
   A significant Chinese API manufacturer with a certified production process for glucose API suitable for parenteral solutions.

Regulatory and Quality Considerations

• Prioritize suppliers with FDA, EMA, or WHO-GMP certification to facilitate regulatory approval.
• The API must comply with Ph. Eur., USP, or JP standards, with appropriate endotoxin and microbial limits.
• Compatibility with plastic containers and stability considerations in IV formulations are critical. Dextrose solutions are compatible with most plastics, but batch stability data is necessary to avoid leaching or degradation.

---

Procurement Considerations

• Regulatory Compliance: Ensure API suppliers hold the necessary certifications and can provide detailed certificates of analysis (COA), stability data, and manufacturing batch records.
• Supply Chain Stability: Evaluate suppliers’ capacity, geographical diversification, and logistical capabilities to mitigate supply disruptions.
• Quality Assurance: Prefer suppliers with proven adherence to GMP/QMS standards, with robust QA/QC processes.
• Cost Efficiency: Balance cost considerations with quality to optimize overall product quality and profitability.

---

Manufacturing & Compatibility

For IV products in plastic containers, API compatibility, especially stability and leaching issues, is paramount. Both Theophylline and Dextrose 5% are chemically stable in common plastics like polypropylene and polyethylene. However, sourcing APIs with recent stability data corroborates their suitability for large-scale IV production and storage.

---

Conclusion

Reliable sourcing of Theophylline and Dextrose 5% APIs is crucial for producing safe, effective IV formulations. Leading global manufacturers such as Mitsubishi Tanabe, Siegfried, Cargill, Roquette, and Tate & Lyle offer high-quality APIs meeting international standards. Procurement strategies should emphasize regulatory compliance, supply chain robustness, and compatibility with storage containers. Strategic supplier relationships, backed by quality assurance and compliance documentation, will ensure uninterrupted supply and product integrity in the sterile injectable market.

---

Key Takeaways

• Theophylline APIs are predominantly sourced from Japan, Switzerland, India, and China, all with GMP-compliant facilities.
• Dextrose 5% APIs are available from North American and European companies with proven quality records.
• Prioritize suppliers with certifications such as WHO-GMP, US FDA, or EMA to facilitate regulatory approval.
• Ensure APIs meet pharmacopeial standards and have recent stability data for parenteral use.
• Diverse supplier bases mitigate supply risks, especially vital in sterile injectable manufacturing.

---

Frequently Asked Questions

1. What are the primary considerations when sourcing Theophylline API for IV formulations?
   Ensuring GMP compliance, regulatory certifications, and high purity standards are paramount. Additionally, availability in bulk quantities and stability data suitable for IV use are critical.

2. Which countries dominate the global Dextrose 5% API supply chain?
   The USA, France, UK, and China are leading producers, with companies like Cargill, Roquette, and Tate & Lyle providing high-quality pharmaceutical-grade dextrose.

3. How do I verify the regulatory compliance of an API supplier?
   Request detailed Certificates of Analysis, GMP certification documents, and ensure their manufacturing site complies with recognized pharmacopeial standards (USP, EP, JP). Regulatory audits can provide further validation.

4. Are there differences in compatibility of APIs with plastic containers?
   Both Theophylline and Dextrose solutions are generally compatible with polypropylene and polyethylene containers; however, recent stability and compatibility data should be reviewed to prevent leaching or degradation.

5. What are the risks associated with sourcing APIs from China or India?
   Potential risks include variability in quality, regulatory compliance concerns, and supply chain disruptions. Selecting suppliers with international certifications and proven track records minimizes these risks.

---

References

[1] U.S. Pharmacopeia (USP). Monographs for Theophylline and Dextrose.
[2] European Pharmacopoeia (EP). Standards for IV excipients and APIs.
[3] World Health Organization (WHO). Good Manufacturing Practices (GMP) guidelines.
[4] Industry reports on API manufacturing and supply chain analyses.