Bulk Pharmaceutical API Sources for SOMOPHYLLIN

Bulk Pharmaceutical API Sources for SOMOPHYLLIN

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		A1755_SIGMA
Molport		MolPort-004-959-540
Hangzhou APIChem Technology		AC-11138
BioChemPartner		BCP0726000247
TimTec		ST50298827
BioChemPartner		BCP9000293
AKos Consulting & Solutions		AKOS015951253

Bulk Active Pharmaceutical Ingredient (API) Sources for: SOMOPHYLLIN

Last updated: July 28, 2025

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Introduction

SOMOPHYLLIN, known chemically as aminophylline, is a bronchodilator used primarily in the management of airway diseases such as asthma and chronic obstructive pulmonary disease (COPD). As a methylxanthine derivative, it functions by inhibiting phosphodiesterase enzymes and antagonizing adenosine receptors, leading to relaxation of airway smooth muscles. Securing reliable and high-quality API sources for SOMOPHYLLIN is critical for pharmaceutical manufacturers aiming to develop safe and efficacious products.

This analysis provides an in-depth overview of global suppliers, manufacturing locations, quality standards, and procurement strategies relevant to sourcing bulk API for SOMOPHYLLIN. It aims to assist stakeholders—manufacturers, traders, and regulatory bodies—in making informed procurement decisions.

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Global API Supply Landscape for SOMOPHYLLIN

1. Leading API Manufacturers

The API market for aminophylline/SOMOPHYLLIN remains relatively consolidated, with several reputable producers spanning Asia, Europe, and North America. The key players are characterized by their manufacturing expertise, compliance with international quality standards, and established export channels.

a. Chinese Manufacturers

China continues to dominate global API supply due to its expansive pharmaceutical manufacturing infrastructure. Several Chinese API producers offer aminophylline, often at competitive pricing, making the country a primary sourcing destination.

• Hubei Best Chemical Co., Ltd.: Recognized for ethylenediamine derivatives, including aminophylline, with GMP certification and adherence to USP and EP standards available upon request.
• Shandong Dayangchem Co., Ltd.: Supplies bulk aminophylline complying with international pharmacopeias, with extensive export experience.
• Jiangsu Hesheng Pharmaceutical Co., Ltd.: Certified for GMP, offering custom synthesis and bulk API equivalents of somophyllin.

b. Indian Manufacturers

India offers a broad spectrum of pharmaceutical intermediates and APIs, with notable companies providing high-quality aminophylline suitable for international markets.

• Exscience Lifesciences Pvt. Ltd.: Known for API manufacturing under rigorous quality control, with adherence to USFDA, EU-GMP, and other standards.
• CIPLA Limited: An established pharmaceutical player with API manufacturing facilities producing aminophylline for bulk consumption globally.
• Micro Labs Limited: Offers GMP-certified aminophylline APIs with proven track records in supply chain reliability.

c. European and North American Suppliers

While less dominant in volume than Asian counterparts, European and North American firms supply premium APIs, often targeting regulated markets.

• BASF Pharma Solutions: Provides pharmaceutical intermediates and APIs, including aminophylline, with stringent quality standards and comprehensive documentation.
• Alfa Aesar (a Thermo Fisher Scientific division): Supplies research-grade and GMP-certified aminophylline with detailed analytical certificates.

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2. Quality Standards and Certifications

For regulatory compliance, API suppliers must adhere to recognized quality standards:

• GMP (Good Manufacturing Practice): Ensures consistent product quality. Most Asian manufacturers certify GMP compliance, especially when exporting to regulated markets.
• Pharmacopoeia Standards: Suppliers often align with US Pharmacopeia (USP), European Pharmacopoeia (EP), and Chinese Pharmacopoeia (ChP). Suppliers typically provide quality certificates matching these standards.
• ISO Certifications: ISO 9001 quality management certifications are common among reputable API producers, indicating reliability in production processes.

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3. Procurement Considerations

a. Pricing and Volume

Asian API suppliers generally offer competitive pricing, suitable for large-volume procurement. However, buyers should consider additional costs related to shipping, customs, and testing.
b. Regulatory Compatibility

Manufacturers compliant with FDA, EMA, or other stringent authorities facilitate smoother registration processes in target markets. Buyers should request detailed documentation, including batch records, analytical data, and stability reports.
c. Lead Times and Supply Reliability

Established suppliers with extensive export experience tend to provide shorter lead times and reliable supply chains, essential for manufacturing continuity. Establishing long-term partnerships with multiple sources mitigates risks.
d. Supplier Verification

Third-party audits, supplier certifications, and prior regulatory inspections are essential for assessing supplier credibility and product quality.

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4. Recent Trends and Developments

• Focus on Certifying Suppliers for Export to Regulated Markets: Many Asian API manufacturers are enhancing GMP certifications and quality controls to meet international standards.
• API Synthesis Innovations: Advancements in synthetic routes aim to improve yield, reduce impurities, and lower production costs.
• Sustainability and Green Chemistry: Some manufacturers are adopting environmentally friendly processes to meet global sustainability expectations.

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Conclusion

Securing high-quality bulk API sources for SOMOPHYLLIN encompasses evaluating reputable manufacturers across geographies, verifying compliance with strict quality standards, and aligning procurement strategies with regulatory requirements. Asian suppliers, particularly Chinese and Indian manufacturers, dominate the market in terms of pricing and capacity, with numerous GMP-certified plants capable of supplying large volumes conforming to international standards.

Regulatory due diligence and establishing reliable supply chains remain essential for pharmacovigilance and market integrity. Fostering strategic, long-term supplier relationships can optimize procurement costs, ensure quality continuity, and streamline regulatory approvals.

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Key Takeaways

• Predominant sources for SOMOPHYLLIN API are Chinese and Indian manufacturers with GMP certification, offering competitive pricing and reliable supply.
• Ensuring supplier compliance with USP, EP, or local regulatory standards is critical for market access.
• Establishing robust verification processes, including audits and certificate review, mitigates supply risks.
• Strategic sourcing should include consideration of lead times, quality consistency, and regulatory support.
• Ongoing market trends favor suppliers investing in sustainable practices and advanced synthetic methodologies, enhancing product quality and supply resilience.

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FAQs

1. What are the primary factors to consider when sourcing SOMOPHYLLIN API?
Regulatory compliance, quality certification (GMP, pharmacopeia standards), supply reliability, pricing, and supplier reputation are critical factors.

2. Are Chinese API manufacturers compliant with international quality standards?
Many Chinese API suppliers hold GMP certifications and align with USP, EP, or other standards, making them suitable for regulated markets. Due diligence remains necessary to verify certification validity.

3. How can I verify the quality of a bulk API supplier?
Request detailed Certificates of Analysis, batch records, GMP certification copies, and third-party audit reports. Visiting manufacturing facilities or conducting independent testing services can further validate quality.

4. What are the typical lead times for API shipments from Asian suppliers?
Lead times vary but generally range from 4 to 12 weeks depending on order size, supplier location, and regulatory clearance requirements.

5. Is it advantageous to diversify API sources for SOMOPHYLLIN?
Yes. Diversification minimizes supply chain disruptions, ensures competitive pricing, and enhances regulatory flexibility.

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Sources

1. [1] European Directorate for the Quality of Medicines & HealthCare (EDQM). "Pharmacopoeia Standards."
2. [2] Chinese Pharmacopoeia Commission. "Chinese Pharmacopoeia."
3. [3] U.S. Pharmacopeia. "USP Standards."
4. [4] Global API Market Reports, 2022.
5. [5] WHO Quality Assurance of Pharmaceuticals, 2021.