Bulk Pharmaceutical API Sources for AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%

Bulk Pharmaceutical API Sources for AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		jg TP@DXUkp^cW\@kUrJJJJXhEQQQSE@iLehvVcfuUMTuUMUTj`@@
Sigma-Aldrich		A1755_SIGMA
MP Biomedicals		213149
Ambinter		Bio-0793
MolPort		MolPort-004-959-540
Hangzhou APIChem Technology		AC-11138
ABI Chem		AC1L1T14

Bulk Active Pharmaceutical Ingredient (API) Sources for: Aminophylline in Sodium Chloride 0.45%

Last updated: August 7, 2025

Introduction

Aminophylline, a vasoactive methylxanthine derivative, is primarily employed in respiratory therapeutics, particularly for managing asthma and COPD exacerbations. The formulation of aminophylline in sodium chloride 0.45% solution facilitates intravenous administration, ensuring rapid onset of action. Securing reliable bulk API sources for aminophylline is critical for pharmaceutical manufacturers aiming to produce consistent, high-quality formulations. This report delineates the current landscape of suppliers offering aminophylline APIs suitable for compounded or commercial injectable products.

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Overview of Aminophylline API Market

Aminophylline is synthesized by complexing theophylline with ethylenediamine, producing a hemihydrate form. Its manufacturing necessitates strict controls over purity, residual solvents, and stability parameters. The global API market for aminophylline is relatively mature, with several established suppliers capable of providing pharmaceutical-grade API adhering to pharmacopeial standards (USP, BP, EP).

The procurement process involves assessing supplier certifications, batch-to-batch consistency, quality assurance programs, and compliance with regulatory standards, especially for injectable formulations. The following sections categorize key API manufacturers aligned with these criteria.

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Major API Suppliers for Aminophylline

1. Jiangxi Huayu Pharmaceutical Co., Ltd. (China)

• Overview: A prominent Chinese manufacturer specializing in methylxanthines, including aminophylline, with GMP certification.
• Quality: Supplies API conforming to USP and EP standards with documented stability data.
• Market Focus: Serving global markets with robust distribution channels for hospital and injectable raw materials.
• Strengths: Competitive pricing, reliable supply chain, and active R&D for process improvements.

2. Parchem Fine & Specialty Chemicals (USA)

• Overview: An established international supplier providing high-quality aminophylline APIs suitable for pharmaceutical manufacturing.
• Quality: Offers APIs that meet pharmacopeial specifications, with extensive quality documentation.
• Compliance: FDA-registered and compliant with ISO standards, providing assurance for injectable-grade APIs.
• Additional Features: Custom packaging and formulation support.

3. Shanghai Haohong Pharmaceutical Co., Ltd. (China)

• Overview: Focused on methylxanthines with a broad portfolio of APIs for respiratory drugs.
• Regulatory Status: GMP-certified manufacturing facilities with a track record of exporting to regulated markets.
• Product Offering: Numerous batches of USP/EP-grade aminophylline API.

4. Aarti Drugs Ltd. (India)

• Overview: Recognized Indian manufacturer of methylxanthine APIs with extensive export experience.
• Quality Measures: ISO and GMP certifications, with APIs meeting international pharmacopeial standards.
• Distribution: Supplies globally, including to North America, Europe, and Asia.

5. Yung Sheng Pharmaceutical Co., Ltd. (Taiwan)

• Overview: Specializes in pharmaceutical intermediates and APIs, including aminophylline.
• Certifications: GMP, ISO, and other compliance standards aligned with international requirements.
• Market Niche: Focus on high-purity APIs for injectable and pharmaceutical preparations.

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Emerging and Niche API Suppliers

Several smaller or boutique API manufacturers focus on high-value, specialized APIs, including aminophylline:

• Tianjin Sinuo Pharmaceutical Co., Ltd. (China): Known for stringent quality control, suitable for GMP-compliant products.
• Glenmark Pharmaceuticals (India): Has proprietary manufacturing processes with high purity standards.
• Merck KGaA (Germany): Less common, but supplies pharmaceutical intermediates, including methylxanthines, under strict quality controls.

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Considerations When Selecting an API Supplier

Regulatory Compliance: Suppliers must demonstrate adherence to GMP, GMP-compliance certifications, and provide comprehensive analytical data. Proper documentation, such as COA (Certificate of Analysis), batch records, and stability data, is essential.

Purity & Specification: API specifications should align with pharmacopeial standards, including assay (purity), residual solvents, heavy metals, and microbial limits, to ensure suitability for injectable formulations.

Supply Chain Reliability: A dependable supply chain minimizes risks of shortages. Long-term partnerships favor consistency, especially for injectable APIs requiring batch-to-batch uniformity.

Pricing & Lead Time: Market dynamics influence API pricing; establishing multiple supplier relationships mitigates supply risks.

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Regulatory and Quality Standards

Global pharmaceutical manufacturing mandates rigorous quality assurance routines. Suppliers must comply with:

• GMP (Good Manufacturing Practices): For assurance of consistent quality.
• Regulatory Certification: US FDA, EMA, PMDA, or WHO prequalification where applicable.
• Pharmacopeial Compliance: USP, EP, or BP standards, verified through certified testing.

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Conclusion

The API sourcing landscape for aminophylline in sodium chloride 0.45% encompasses mature manufacturers predominantly based in China, India, and Taiwan, with several supplies meeting stringent international standards. Pharmaceutically qualified suppliers such as Jiangxi Huayu Pharmaceutical, Parchem, Shanghai Haohong, Aarti Drugs, and Yung Sheng represent the primary options for global procurement. Securing APIs from these suppliers requires proactive qualification processes to ensure regulatory compliance, quality, and consistent supply.

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Key Takeaways

• Reliable suppliers are critical for maintaining supply integrity, especially for injectable APIs like aminophylline.
• GMP compliance and pharmacopeial standards are non-negotiable in selecting API sources for pharmaceutical use.
• Chinese, Indian, and Taiwanese manufacturers dominate the aminophylline API supply market, offering competitive pricing combined with FDA or EMA registration.
• Due diligence, including testing and certification review, minimizes compliance risks.
• Long-term supplier relationships can streamline procurement and improve quality assurance for this high-demand API.

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FAQs

1. What factors determine the choice of an aminophylline API supplier for pharmaceutical manufacturing?
Primarily, supplier compliance with GMP and pharmacopeial standards, consistency in quality, regulatory certifications, supply reliability, and competitive pricing influence selection.

2. Are there any regulatory restrictions on sourcing aminophylline APIs internationally?
Yes, sourcing APIs from non-GMP-certified or uncertified suppliers can pose regulatory risks. Regulatory agencies scrutinize the quality and safety of APIs, especially for injectable formulations.

3. How does the purity of aminophylline API impact its application in injectable formulations?
Higher purity reduces the risk of adverse reactions and ensures therapeutic efficacy; impurities may affect safety and stability, making compliance with pharmacopeial specifications essential.

4. Can custom formulations or specifications for aminophylline APIs be developed?
Yes, reputable suppliers offer custom synthesis and specifications, provided regulatory and quality standards are met.

5. What is the typical lead time for sourcing aminophylline API from established suppliers?
Lead times generally range from 4 to 12 weeks, depending on production capacity, order size, and shipping logistics.

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Sources
[1] Pharmacopoeial standards and industry reports, 2022.
[2] Suppliers’ official websites and product datasheets.
[3] Market analysis papers on methylxanthine API production and distribution.