Bulk Pharmaceutical API Sources for THEOPHYLLINE-SR

Bulk Pharmaceutical API Sources for THEOPHYLLINE-SR

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		T1633_SIGMA
Vitas-M Laboratory		STK397040
TCI (Tokyo Chemical Industry)		T0179

Bulk Active Pharmaceutical Ingredient (API) Sources for Theophylline-SR

Last updated: August 7, 2025

Introduction

The development and manufacturing of sustained-release (SR) formulations of theophylline hinge critically on the reliable procurement of high-quality bulk APIs. Theophylline-SR, a widely used bronchodilator for conditions such as chronic obstructive pulmonary disease (COPD) and asthma, demands pharmaceutical-grade active ingredients that meet rigorous standards for purity, potency, and consistency. This article provides a comprehensive overview of the key sources of bulk theophylline-SR API, highlighting leading manufacturers, geographic considerations, quality assurance protocols, and strategic procurement pathways essential for pharmaceutical companies.

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Overview of Theophylline-SR API

Theophylline is a methylxanthine derivative with bronchodilatory effects. Its sustained-release formulations improve dosing convenience and therapeutic adherence. The manufacturing of the API involves complex chemical synthesis, requiring strict control over residual solvents, by-products, and enantiomeric purity. Given the API’s central role in respiratory therapeutics, sourcing from reputable suppliers ensures quality, regulatory compliance, and supply chain stability.

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Leading Global API Manufacturers for Theophylline-SR

1. China-Based Suppliers

China remains a dominant supplier of APIs, including theophylline-SR, owing to its extensive chemical manufacturing infrastructure and cost advantages. Major Chinese producers often supply both bulk APIs and finished formulations, with facilities accredited by GMP (Good Manufacturing Practice).

• North China Pharmaceutical Group Corporation (NCPC): A recognized supplier offering high-purity theophylline APIs compliant with international standards. NCPC invests in quality control and GMP certification, enabling export to global markets.
• Hubei Yinhua Pharmaceutical Co., Ltd.: Specializes in the synthesis of methylxanthines, delivering both anhydrous and sustained-release grades of theophylline API tailored for pharmaceutical applications.
• Wuhan Youji Pharmaceutical Co., Ltd.: Offers GMP-certified theophylline APIs with documented specifications suitable for SR formulations.

2. India-Based Suppliers

India's robust pharmaceutical sector provides cost-effective, high-quality APIs, adhering to stringent quality standards. Indian manufacturers often have extensive experience in large-scale chemical synthesis and export logistics.

• Shreeram Valoog Pharma: Supplies pharmaceutical-grade theophylline APIs that meet USP and EP standards. They maintain GMP compliance and are registered with major regulatory bodies.
• Aurobindo Pharma: Offers a range of methylxanthines, including theophylline, with a focus on purity and regulatory adherence.
• Hospira (Pfizer): Although primarily a formulary company, Hospira's legacy operations included API manufacturing with high-quality standards.

3. European and North American Suppliers

While less dominant in API production, some European and North American firms specialize in specialty chemicals or provide high-grade APIs for niche applications.

• Bachem AG (Switzerland): Provides custom synthesis services and high-purity APIs, including theophylline, with compliance to EU GMP standards.
• LKT Laboratories (USA): A preclinical and GMP API supplier noted for research-grade and pharmaceutical-grade methylxanthines.

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Strategic Considerations in API Sourcing

Regulatory Compliance and Certifications

Procurement of theophylline-SR APIs must prioritize suppliers with GMP certification, supporting compliance with the US FDA, EMA, and other regulatory authorities. Certificate of analysis (COA), stability data, and bioequivalence information are crucial for validation processes.

Quality Control and Purity Standards

Suppliers should provide detailed specifications verifying purity (>99%), residual solvent levels conforming to ICH Q3C guidelines, and stereoisomer content if applicable. Demonstrated consistent manufacturing processes reduce batch-to-batch variability, essential for SR formulations.

Supply Chain Stability and Lead Times

Given high demand, establishing multiple sourcing channels mitigates supply disruptions. Preferred suppliers maintain robust logistics networks, with contingency options for raw material shortages or geopolitical issues.

Cost Considerations

While cost-efficient sourcing is advantageous, low prices should not compromise quality. Long-term contracts often facilitate better pricing and supply security, especially with bulk orders.

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Emerging Trends and Future Directions

Advancements in green chemistry and process intensification are shaping the future of theophylline API manufacturing. Biocatalysis and solvent-free processes, currently in developmental stages, promise cleaner and more sustainable production routes. Additionally, increasing regulatory focus on trace contaminants prompts manufacturers to adopt upgraded analytical techniques, enhancing product safety for SR formulations.

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Conclusion

Reliable sourcing of theophylline-SR API is paramount for pharmaceutical companies aiming to develop effective and safe sustained-release inhalers or oral formulations. Leading suppliers across China, India, Europe, and North America offer high-quality APIs, with established certifications and quality standards. Strategic procurement, emphasizing regulatory compliance and supply chain resilience, ensures continuity and product integrity.

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Key Takeaways

• Reputable suppliers such as NCPC, Shreeram Valoog, and Bachem provide high-purity theophylline APIs suitable for SR formulations.
• Regulatory compliance, especially GMP certification and detailed documentation, is non-negotiable in API sourcing.
• Diversification of suppliers mitigates risks related to supply disruptions or geopolitical factors.
• Emerging manufacturing innovations contribute to cleaner, more sustainable API production, aligning with global regulatory trends.
• Cost versus quality balance remains critical; long-term partnerships can yield better reliability and value.

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FAQs

1. What are the critical quality attributes to verify in theophylline-SR APIs?
Key attributes include purity (>99%), residual solvent levels per ICH Q3C standards, enantiomeric purity if relevant, and consistent batch-to-batch quality verified via comprehensive analytical testing.

2. How do Chinese and Indian API manufacturers compare regarding quality and regulatory adherence?
Both countries host leading GMP-certified facilities adhering to international standards. Chinese and Indian suppliers frequently obtain certifications such as ISO and GMP, with Indian firms often preparing for US FDA and EU approval processes.

3. Can liposomal or alternative delivery systems influence API sourcing?
Yes. Variations in formulation strategies may require customized API grades or additional modifications. Suppliers capable of providing tailored APIs with specific particle size or excipient compatibility are advantageous.

4. What documentation should I request when sourcing theophylline-API?
Request comprehensive Certificates of Analysis (COA), GMP certificates, stability data, detailed specifications for purity and residual solvents, and regulatory documentation supporting compliance with regional standards.

5. What are the implications of geopolitical factors on API sourcing?
Trade restrictions, tariffs, or regional instability can disrupt supply chains. Diversifying suppliers across regions and establishing long-term relationships help mitigate these risks.

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References:

[1] U.S. Pharmacopeia, 43rd Edition, Theophylline Monograph.
[2] European Pharmacopoeia, 10th Edition.
[3] ICH Q3C(R6) Guidelines for Residual Solvents.
[4] Grand View Research, API Market Report, 2022.
[5] Pharmaceutical Technology, "Global API Manufacturing Trends," 2023.