Bulk Pharmaceutical API Sources for THEOPHYLLINE SODIUM GLYCINATE

Bulk Pharmaceutical API Sources for THEOPHYLLINE SODIUM GLYCINATE

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		23663537
AK Scientific, Inc. (AKSCI)		K416
ChemTik		CTK3E8046
Changzhou Highassay Chemical Co., Ltd		my_sub3571

Bulk Active Pharmaceutical Ingredient (API) Sources for: Theophylline Sodium Glycinate

Last updated: August 2, 2025

Introduction

Theophylline sodium glycinate is a pharmaceutical compound formulated as an active pharmaceutical ingredient (API) used primarily in respiratory therapies. Known for its bronchodilator properties, it is prescribed to manage airway obstructive conditions such as asthma and chronic obstructive pulmonary disease (COPD). As demand for high-quality APIs increases globally, pharmaceutical companies seek reliable sources for bulk procurement of Theophylline sodium glycinate. This report examines the current suppliers, manufacturing landscape, and procurement considerations relevant to bulk API sourcing for this compound.

Overview of Theophylline Sodium Glycinate

Theophylline sodium glycinate is a salt derivative of the methylxanthine class, combining theophylline with glycine and sodium. It exhibits improved water solubility and pharmacokinetic profiles over free theophylline, facilitating efficient absorption and reduced toxicity. Its synthesis involves complex chemical processes requiring strict quality controls to ensure purity and consistency for pharmaceutical use (reference [1]).

Global API Manufacturing Landscape

Major Producing Countries

The production of theophylline derivatives, including sodium glycinate, is concentrated within specific regions known for active pharmaceutical ingredient manufacturing:

• China: Dominates as a principal supplier due to its expansive API manufacturing infrastructure, cost-competitive production, and high-volume output. Renowned Chinese API manufacturers such as Zhejiang Huahai Pharmaceuticals and North China Pharmaceutical Group have capabilities for synthesizing various methylxanthines, including theophylline derivatives [2].

• India: Hosts several WHO-GMP compliant API manufacturers like Dr. Reddy's Laboratories, Aarti Industries, and Natco Pharma that produce methylxanthines and their derivatives, often serving both domestic and export markets.

• Europe and the United States: While less dominant in API bulk production, these regions tend to focus on high-quality, GMP-compliant manufacturing, often serving as a source of premium APIs for large pharmaceutical companies.

Key Manufacturers and Suppliers

A review of industry databases and regulatory filings reveals several established and emerging suppliers of theophylline sodium glycinate:

• Zhejiang Huahai Pharmaceuticals (China): Known for a broad portfolio of methylxanthine APIs, including theophylline salts, with stringent quality assurance aligned with international standards.

• Pakpharma (Pakistan): Offers theophylline APIs with GMP certification, serving regional markets.

• Aarti Industries (India): Produces various methylxanthine APIs and intermediates, including formulations suitable for bulk API extraction.

• Jiangsu Hengrui Medicine Co., Ltd. (China): Engages in synthesizing derivative APIs, including salts of theophylline.

Note: Due to the complex synthesis route and rigorous quality requirements, most suppliers provide APIs with high purity levels (≥99%) conforming to pharmacopeial standards.

Sourcing Considerations

Quality and Compliance

Ensuring API purity, stability, and compliance with pharmacopeial standards (e.g., USP, EP, BP) is critical. Suppliers must have robust quality management systems, documentation, and validation protocols.

Regulatory Approvals

Manufacturers should possess necessary regulatory approvals, including GMP certification, to facilitate international procurement and minimize supply chain disruptions.

Pricing and Lead Times

Cost competitiveness varies among suppliers. Chinese manufacturers typically offer lower pricing due to scale economies, while suppliers from Europe and North America may command premium prices owing to higher-quality standards and stricter regulations. Lead times are affected by manufacturing capacity, regulatory clearance, and logistics.

Supply Chain Risks

Dependence on geographically concentrated suppliers introduces risks such as geopolitical tensions, trade restrictions, or logistical disruptions. Diversification of supplier base is advised.

Sourcing Channels

• Direct Procurement: Typically through manufacturer agreements, requiring extensive due diligence and quality audits.
• Third-party Trade Platforms: Such as Alibaba or specialized chemical intermediates brokers, offer a broader supplier network but necessitate rigorous qualification processes.
• Licensed Distributors: Authorised intermediaries ensure compliance and facilitate quality assurance.

Emerging Trends and Challenges

• Increasing Quality Demands: Pharmaceutical markets globally are tightening quality controls, pressuring suppliers to upgrade production facilities.
• Sustainable Production: Emphasis on environmentally friendly synthesis processes influences supplier selection.
• Supply Chain Traceability: Regulatory agencies demand detailed documentation and traceability, influencing procurement decisions.

Conclusion

The sourcing of bulk Theophylline sodium glycinate APIs involves navigating a multifaceted landscape characterized by regional manufacturing hubs, compliance standards, and market dynamics. Reliable suppliers tend to be established manufacturers in China, India, and selected regions in Europe. Strategic procurement involves balancing quality, cost, lead times, and regulatory compliance, with a focus on establishing strong supplier relationships and conducting thorough assessments.

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Key Takeaways

• Preferred Regions: China and India dominate API production, offering cost-effective sources with high-quality standards; European and North American suppliers cater to premium markets.
• Supplier Qualification: Critical to verify GMP compliance, quality certifications, and manufacturing capacity to ensure API integrity.
• Regulatory Compliance: Ensure suppliers adhere to pharmacopeial standards and possess necessary approvals for international export.
• Supply Chain Diversity: Diversify suppliers to mitigate risks associated with geopolitical or logistical disruptions.
• Emerging Standards: Focus on sustainability and traceability may increasingly influence supplier selection.

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FAQs

Q1: What are the primary factors to consider when sourcing Theophylline sodium glycinate APIs?
A1: Quality assurance, regulatory compliance, manufacturing capacity, cost, lead times, supplier reputation, and supply chain stability.

Q2: Which countries are the leading producers of Theophylline sodium glycinate?
A2: China and India are the principal manufacturing hubs due to their extensive API production facilities and cost competitiveness.

Q3: How can companies verify the quality of bulk API suppliers?
A3: Through assessing GMP certifications, regulatory approvals (e.g., FDA, EMA), conducting supplier audits, reviewing batch testing records, and requesting documented compliance with pharmacopeial standards.

Q4: What risks are associated with sourcing APIs from China?
A4: Potential risks include regulatory fluctuations, quality variability, geopolitical trade tensions, and logistical delays. Due diligence and diversification mitigate these risks.

Q5: Are there alternatives to Chinese and Indian suppliers for Theophylline sodium glycinate?
A5: Yes, European and North American manufacturers providing high-quality APIs are available, though often at higher costs due to stricter regulatory and quality standards.

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Sources:

[1] European Pharmacopoeia, The Pharmacopoeial Standards for Theophylline.
[2] Industry Reports on API Manufacturing (e.g., GlobalData, IQVIA).