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

Bulk Pharmaceutical API Sources for THEOPHYLLINE IN 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 in Dextrose 5% in Plastic Container

Last updated: July 31, 2025

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Introduction

Theophylline, a methylxanthine derivative, remains a vital pharmaceutical agent, primarily utilized as a bronchodilator for asthma and chronic obstructive pulmonary disease (COPD). When formulated as an intravenous solution, especially in dextrose 5% in plastic containers, the integrity and quality of the active pharmaceutical ingredient (API)—theophylline—are critical for therapeutic efficacy and patient safety. This comprehensive review delineates primary bulk API sources for theophylline, emphasizing suppliers capable of producing pharmaceutical-grade material suitable for injectable formulations in plastic containers.

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Regulatory and Quality Considerations for API Sourcing

Choosing a reliable API supplier for theophylline in intravenous formulations requires meticulous attention to regulatory compliance, manufacturing standards, and supply chain integrity. The API must conform to pharmacopeial standards—USP, EP, or JP—ensuring purity, consistency, and appropriate specifications. Oversight by regulatory agencies such as the FDA, EMA, or PMDA is vital, especially for APIs intended for injectable products. Suppliers should demonstrate compliance with cGMP (current Good Manufacturing Practices) and possess robust quality assurance protocols.

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Major Global API Manufacturers of Theophylline

1. Thermo Fisher Scientific (formerly FISHER Biosciences)

• Overview: A leader in pharmaceutical ingredients, Thermo Fisher offers high-quality, USP-grade theophylline APIs. Their manufacturing facilities adhere strictly to cGMP, ensuring batch-to-batch consistency.
• Capabilities: Extensive global distribution networks, flexible batch sizes, and comprehensive documentation facilitate their role as a reliable API source.
• Application: Suitable for sterile injectable formulations, including in dextrose 5% solutions in plastic containers.

2. Apotex Inc.

• Overview: A major Canadian generic pharmaceutical manufacturer with WHO-GMP certifications.
• API Portfolio: Manufactures high purity theophylline APIs compliant with international standards.
• Quality Assurance: Robust QA/QC systems, validated processes, and extensive regulatory dossiers support their qualification for injectable APIs.

3. Dr. Reddy’s Laboratories

• Overview: An Indian multinational with global footprints, Dr. Reddy’s supplies pharmaceutical-grade APIs, including theophylline.
• Manufacturing Standards: Complies with US FDA, EDQM, and other regulatory standards.
• Product Quality: Focus on high purity, low impurity profile, suitable for injectable drugs.

4. Jiangsu Hengrui Medicine Co., Ltd.

• Overview: A leading Chinese pharmaceutical manufacturer specializing in active ingredients, including theophylline.
• Regulatory Status: Noted for GMP certification and adherence to international quality standards.
• Supply Scope: Capable of large-scale production meet global demands.

5. Zhejiang Hisun Pharmaceutical Co., Ltd.

• Overview: Specializes in medicinal chemicals, including xanthines like theophylline.
• Quality Policy: Emphasizes purity, stability, and consistent supply, suitable for pharmaceutical manufacturing.

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Specialty and Niche API Suppliers

Beyond large pharmaceutical manufacturers, specialized API suppliers and trading firms provide high-purity theophylline for sterile formulations, often with extensive regulatory dossiers for international markets:

• Cambridge Isotope Laboratories: Supplier of isotopically labeled theophylline for research; also offers pharmaceutical-grade APIs.
• FIS Research and Development Pvt. Ltd.: Indian API manufacturer with a focus on high-quality theophylline suitable for injectables.

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Criteria for API Selection for Dextrose 5% IV Solutions

Choosing an API source requires validation on several fronts:

• Purity & Impurity Profile: Thetheophylline API must meet pharmacopeial standards with minimal residual solvents and heavy metals.
• Particle Size & Solubility: API granulation should be suitable for sterile filtration and compatibility with plastic containers.
• Certifications & Documentation: Certificates of Analysis (CoA), GMP compliance certificates, stability data.
• Supply Stability & Lead Time: Reliable supply chain to meet manufacturing demands, avoiding shortages.
• Regulatory Support: Ability to provide batch documentation suitable for regulatory submissions.

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Challenges in API Sourcing for Injectable Theophylline

• Impurity Management: The injectable formulations require APIs with minimal impurities—particularly related to methylxanthines and residual solvents.
• Regulatory Approvals: Variability in API quality standards across regions complicates global sourcing.
• Supply Chain Disruptions: Political, logistical, and raw material shortages affect API availability.
• Sterility & Packaging: Although API is typically supplied in bulk powder, compatibility with sterile manufacturing processes, proper packaging in plastic containers, and stability are crucial considerations.

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Emerging Trends and Innovative Suppliers

• API Contract Manufacturing: Outsourcing to CDMOs specializing in sterile APIs ensures adherence to quality, sterility, and packaging standards aligned with pharmaceutical requirements.
• Single-Source Partnerships: Establishing long-term relationships with approved suppliers minimizes risks and ensures compliance throughout the product lifecycle.
• Use of Synthetic & Crystalline Forms: High-purity crystalline theophylline APIs improve solubility and uniformity in injectable solutions.

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Conclusion

Theophylline suppliers capable of providing high-quality, pharmacopeial-grade bulk APIs are available globally, including firms from North America, Europe, India, and China. When sourcing for formulations in dextrose 5% in plastic containers, procurement should prioritize manufacturers with cGMP compliance, extensive regulatory documentation, and proven track records in sterile API supply. Critical evaluation of API purity, impurity profile, particle size, and supply chain reliability is essential to maintain pharmaceutical standards and patient safety.

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Key Takeaways

• Regulatory compliance is paramount: Select suppliers with validated manufacturing processes and clear documentation aligning with pharmacopeial standards.
• Focus on purity and impurity profile: Especially for injectable APIs, the impurity profile directly affects safety and efficacy.
• Ensure supply chain stability: Long-term partnerships with established manufacturers mitigate risks associated with shortages.
• Evaluate API compatibility: Particle size, solubility, and packaging options influence formulation success.
• Consider regional compliance: Suppliers with U.S., European, or WHO certifications streamline regulatory approval processes.

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FAQs

1. What are the most reputable suppliers for theophylline API suitable for injectable formulations?
Leading suppliers include Thermo Fisher Scientific, Apotex, Dr. Reddy’s Laboratories, Jiangsu Hengrui Medicine, and Zhejiang Hisun Pharmaceutical, all of which adhere to international manufacturing and quality standards suitable for sterile injectable APIs.

2. What regulatory standards should API suppliers meet for injectable theophylline?
Suppliers should comply with cGMP, possess relevant certifications such as USP or EP, and provide comprehensive documentation—including Certificates of Analysis, stability data, and impurity profiles—to facilitate regulatory approvals.

3. How does impurity profile impact the use of theophylline API in dextrose solutions?
Impurities can cause toxicity or reduce efficacy, especially in sensitive injectable formulations. Therefore, APIs must have minimal residual solvents, heavy metals, and process-related impurities, with strict acceptance criteria.

4. Are there regional differences in API sourcing for theophylline?
Yes, sourcing options vary by region due to differing regulatory requirements, manufacturing capabilities, and quality standards. For example, North American and European suppliers often face stringent qualification processes, whereas Indian and Chinese suppliers may offer cost-effective alternatives with validated quality.

5. How does API particle size influence formulation stability in plastic containers?
Optimal particle size facilitates solubility and filtration, reduces aggregation risk, and ensures uniform dosing. APIs with inappropriate particle size may cause filtration difficulties or stability issues in dextrose IV solutions.

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References

1. U.S. Pharmacopeia. USP–USP-NF General Chapter. Pharmaceutical ingredients and standards. (2022).
2. European Pharmacopoeia. Monograph on Theophylline. European Directorate for the Quality of Medicines & HealthCare. (2021).
3. Regulatory agencies’ API sourcing guidelines (FDA, EMA).
4. Industry reports on API manufacturers and supply chain analysis (Q3 2022).
5. WHO Guidelines on the Quality of Manufactured Medicinal Products (2019).