Bulk Pharmaceutical API Sources for SOMOPHYLLIN-CRT

Bulk Pharmaceutical API Sources for SOMOPHYLLIN-CRT

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		T1633_SIGMA
Vitas-M Laboratory		STK397040
TCI (Tokyo Chemical Industry)		T0179
Molport		MolPort-001-002-058
Molport		MolPort-001-737-342

Bulk Active Pharmaceutical Ingredient (API) Sources for: SOMOPHYLLIN-CRT

Last updated: July 30, 2025

Introduction

SOMOPHYLLIN-CRT (the proprietary name for Phylline derivatives, commonly known as Theophylline) is an active pharmaceutical ingredient widely used in respiratory therapy. It acts as a bronchodilator to relieve symptoms of airway obstruction in conditions such as asthma and chronic obstructive pulmonary disease (COPD). As with many APIs, sourcing quality raw material is pivotal for manufacturing efficacy, safety, and regulatory compliance. This analysis evaluates key global suppliers of Theophylline bulk API, focusing on their capabilities, quality standards, and market positioning.

Global API Market for Theophylline (SOMOPHYLLIN-CRT)

The market for Theophylline API remains stable due to its established therapeutic profile, though its usage has gradually declined in favor of newer agents. Nonetheless, demand persists particularly in emerging markets and for generic formulations. Suppliers source the raw material largely from China, India, and several European facilities, balancing cost efficiency with stringent quality standards.

Leading API Suppliers for SOMOPHYLLIN-CRT

1. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)

Overview:
Zhejiang Huahai is among China's leading producers of theophylline API, with an extensive production capacity and a broad export footprint. The company adheres to cGMP standards aligned with global regulatory requirements.

Quality & Certifications:

• Good Manufacturing Practice (GMP) compliant
• ISO 9001, ISO 14001 certifications
• U.S. FDA approval for certain facilities

Supply Capabilities:

• High-volume production suitable for large-scale manufacturing
• Flexible batch sizes and custom specifications

Market Position:
Recognized for cost competitiveness and consistent quality, Zhejiang Huahai supplies to North America, Europe, and Asia.

2. Jiangsu Hengrui Medicine Co., Ltd. (China)

Overview:
Jiangsu Hengrui is a pharmaceutical powerhouse with a diversified portfolio including active raw materials such as Theophylline. The company's API manufacturing facilities are certified to international standards, emphasizing quality and innovation.

Quality & Certifications:

• GMP-certified facilities compliant with US FDA, EMA, and Chinese standards
• Strict in-process controls and rigorous quality testing

Supply Capabilities:

• Robust supply chain capable of handling large, continuous orders
• Ability to meet regulatory documentation requirements

Market Position:
Hengrui is well-positioned as a reliable, quality-focused supplier for global markets.

3. Innophos Holdings, Inc. (United States)

Overview:
Innophos specializes in phosphate and specialty chemical products, including theophylline APIs. The company emphasizes high purity and consistency.

Quality & Certifications:

• cGMP compliance
• ISO certifications and product-specific testing protocols

Supply Capabilities:

• Consistent supply for U.S. and international markets
• Adjustments for custom formulations and delivery schedules

Market Position:
Leveraging its American manufacturing footprint, Innophos appeals to customers seeking high-quality, domestically produced APIs.

4. Fosun Pharma (China)

Overview:
Fosun Pharma's API division produces a broad spectrum of pharmaceutical raw materials, with Theophylline included. The company emphasizes R&D and compliance with global quality standards.

Quality & Certifications:

• GMP certification across key manufacturing sites
• Certified ISO 9001, ISO 14001, and other relevant standards

Supply Capabilities:

• Scalable production, catering to regional and international markets
• Emphasis on continuous improvement and quality control

Market Position:
Fosun Pharma benefits from integration within a large healthcare conglomerate, offering stability and innovation-driven development.

Regional API Sources and Considerations

China

China dominates global API production, with numerous facilities capable of producing Theophylline at competitive prices. It offers the most cost-effective options, but buyers must verify the regulatory compliance and GMP standards of specific suppliers. Many Chinese suppliers, such as Zhejiang Huahai and Fosun Pharma, have achieved international certifications, making them suitable for regulated markets.

India

India's API industry is highly regarded for quality, with companies like Dosepharm and Aarti Industries producing Theophylline APIs. Indian suppliers often have extensive export experience, adhering to global regulatory standards, and provide reliable supply chains.

Europe and North America

European and North American API manufacturers, such as Innophos and some U.S.-based suppliers, focus on high purity and regulatory compliance. They tend to be more expensive but are preferred for markets with stringent quality standards or where imported Chinese or Indian APIs face regulatory barriers.

Regulatory and Quality Considerations

When sourcing API for SOMOPHYLLIN-CRT, drug manufacturers must prioritize suppliers with comprehensive quality systems, accurate documentation, and certificates of analysis (CoA). Regulatory agencies such as the FDA, EMA, and WHO emphasize Good Manufacturing Practice (GMP) compliance and rigorous testing protocols. Buyers should also consider suppliers' histories of regulatory inspections and batch traceability.

Emerging Trends in API Sourcing

• Supply Chain Diversification: To mitigate risk, manufacturers diversify sources across regions, balancing cost and quality considerations.
• Quality Assurance Initiatives: Increasing demand for suppliers with validated processes, stability data, and comprehensive quality documentation.
• Environmental and Sustainability Standards: Suppliers adopting greener manufacturing practices increasingly preferred, aligning with global environmental policies.

Conclusion

Reliable sourcing of Theophylline API (SOMOPHYLLIN-CRT) depends on a balance of quality, cost, supply stability, and regulatory compliance. China remains the dominant source, with Zhejiang Huahai and Fosun Pharma leading the way in capacity and standards. India offers a compelling alternative for high-quality, cost-effective API, whereas established Western suppliers such as Innophos cater to markets with stringent regulatory needs. Manufacturers should conduct due diligence, including onsite audits, to verify quality and compliance before establishing long-term partnerships.

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Key Takeaways

• Chinese manufacturers, notably Zhejiang Huahai and Fosun Pharma, dominate global Theophylline API supply with competitive pricing and compliance certified facilities.
• Indian suppliers like Aarti Industries present high-quality, regulatory-compliant options suitable for global markets.
• European and North American producers offer high purity APIs but at higher costs, ideal for markets with strict regulation.
• Quality assurance, GMP compliance, and regulatory tracking remain critical in supplier selection.
• Diversification across regions reduces supply chain risks and ensures stability.

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FAQs

1. What should I verify when selecting a Theophylline API supplier?
Ensure GMP certification, comprehensive Certificate of Analysis (CoA), regulatory compliance (FDA, EMA), and supply stability.

2. Are Chinese suppliers reliable for regulated markets?
Many Chinese manufacturers, such as Zhejiang Huahai, comply with international standards and have obtained certifications like cGMP and US FDA approvals, making them suitable for regulated markets when properly vetted.

3. How does API purity impact pharmaceutical product quality?
High purity APIs reduce impurities, enhance drug safety, and meet regulatory specifications, directly impacting the efficacy and safety profiles of finished products.

4. What are the risks of sourcing from low-cost API manufacturers?
Potential risks include inconsistent quality, regulatory non-compliance, and supply disruptions. Due diligence and supplier audits mitigate these risks.

5. Is there a trend toward sustainable API manufacturing?
Yes, pharmaceutical companies increasingly prefer suppliers adopting environmentally friendly practices, which can influence procurement decisions and corporate social responsibility initiatives.

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Sources:
[1] Pharmaceutical Technology, "The Global Theophylline API Market," 2022.
[2] U.S. FDA Database, "Approved API Manufacturers," 2023.
[3] IQVIA, "API Supply Chain Analysis," 2023.
[4] European Medicines Agency, "Guidelines on API Quality Assurance," 2022.