Suppliers and packagers for generic pharmaceutical drug: AMINOPHYLLINE

AMINOPHYLLINE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hospira	AMINOPHYLLINE	aminophylline	INJECTABLE;INJECTION	087242	ANDA	Henry Schein, Inc.	0404-9813-10	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9813-10) / 10 mL in 1 VIAL, SINGLE-DOSE	2022-01-08
Hospira	AMINOPHYLLINE	aminophylline	INJECTABLE;INJECTION	087242	ANDA	Henry Schein, Inc.	0404-9814-20	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9814-20) / 20 mL in 1 VIAL, SINGLE-DOSE	2022-01-08
Hospira	AMINOPHYLLINE	aminophylline	INJECTABLE;INJECTION	087242	ANDA	Hospira, Inc.	0409-5921-01	25 VIAL, SINGLE-DOSE in 1 TRAY (0409-5921-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-5921-16)	2005-05-10

Suppliers for the Pharmaceutical Drug: Aminophylline

Last updated: July 27, 2025

Introduction

Aminophylline, a compound used primarily in respiratory conditions such as asthma, chronic obstructive pulmonary disease (COPD), and bronchospasm, remains a critical medication in clinical settings. This methylxanthine derivative combines theophylline with ethylenediamine, enhancing its solubility and bioavailability. As demand persists globally, understanding the landscape of suppliers for aminophylline is essential for pharmaceutical companies, healthcare providers, and regulatory agencies aiming for supply chain resilience, cost efficiency, and regulatory compliance.

Market Overview of Aminophylline Suppliers

The aminophylline supply chain encompasses a diverse array of manufacturers, primarily concentrated in India, China, and Europe. These suppliers manufacture aminophylline in bulk, supplying finished dosage forms or active pharmaceutical ingredients (APIs) to downstream pharmaceutical companies.

Approximately 60-70% of the global aminophylline demand is supplied by Indian pharmaceutical manufacturers, owing to cost competitiveness, established manufacturing infrastructure, and capacity expansion initiatives. Chinese suppliers also play an integral role, especially in raw material provision and intermediates. European and North American firms target niche markets and provide high-purity APIs for regulated markets.

Key Suppliers of Aminophylline API

Indian Manufacturers

India dominates global aminophylline API production, with key players including:

• Aspen Pharmacare: Although primarily South African, Aspen operates manufacturing units in India producing aminophylline APIs and formulations. Its offerings meet stringent regulatory standards, catering to multiple markets globally.

• Sun Pharmaceutical Industries Ltd.: Recognized for extensive APIs portfolio, Sun Pharma manufactures aminophylline APIs meeting WHO-GMP standards, serving both domestic and international markets.

• Aurobindo Pharma: Active in generic APIs, Aurobindo supplies aminophylline with high manufacturing standards, including ISO and cGMP compliance.

• Hetero Labs: Known for bulk APIs, Hetero supplies aminophylline derivatives and intermediates, emphasizing quality assurance.

• Lupin Limited: Its manufacturing units produce aminophylline APIs designed for both hospital and OTC formulations across regulated sectors.

Chinese Suppliers

China’s API producers provide cost-competitive aminophylline APIs, mainly for less regulated markets or bulk export:

• North China Pharmaceutical Group Corporation (NCPC): A major API producer with a focus on methylxanthines, including aminophylline.

• Shandong Xinhua Pharmaceutical Co.: Offers aminophylline APIs compliant with international standards, with a focus on export markets.

• Jiangsu Kanabo Pharmaceutical Co. Ltd.: Supplies aminophylline APIs with stability and high purity profiles.

European and North American Suppliers

While smaller compared to Asian counterparts, these suppliers cater to markets with stringent regulatory requirements:

• Siegfried AG (Switzerland): Offers high-quality aminophylline APIs for injectable and oral formulations, meeting EU-GMP standards.

• CordenPharma (Germany): Provides customized API synthesis including aminophylline for specialized applications.

• Westminster Pharmaceuticals (USA): Produces aminophylline APIs primarily for the North American and global markets, emphasizing cGMP compliance and high purity.

Manufacturing and Supply Chain Dynamics

The supply chain for aminophylline faces several dynamics:

• Regulatory Scrutiny: Suppliers must comply with cGMP guidelines for APIs especially for markets like the US FDA, EMA, and PMDA. This compliance ensures product quality, influencing the selection of suppliers.

• Capacity Constraints: Recent global supply chain disruptions, notably during the COVID-19 pandemic, have highlighted vulnerabilities in sourcing APIs from certain regions. Indian and Chinese manufacturers temporarily faced capacity limitations, prompting pharma companies to diversify sources.

• Price Sensitivity: Cost considerations are a significant driver, especially in emerging markets. Suppliers offering competitively priced APIs with consistent quality gain preference.

• Innovation and Quality Improvements: Suppliers investing in advanced purification technologies and process improvements bolster market confidence.

Regulatory Landscape

API suppliers must align with regulatory frameworks to export aminophylline APIs. India’s regulatory authority (DCGI), China's CFDA (now NMPA), the European EMA, and the US FDA vet manufacturing sites through rigorous inspections. Suppliers compliant with international standards, such as WHO-GMP, US FDA cGMP, and EDQM standards, are favored in global supply chains.

Emerging Trends and Future Outlook

• Increasing Localization: Some pharmaceutical companies are investing in onshore manufacturing to mitigate geopolitical and supply chain vulnerabilities.

• Sustainability Initiatives: Suppliers adopting environmentally friendly manufacturing processes, adhering to green chemistry principles, are gaining a competitive edge.

• Technological Innovation: Use of continuous manufacturing, high-throughput purification, and spectroscopic monitoring enhances API quality and process efficiency.

• Consolidation Trends: Industry consolidation among API manufacturers may streamline supply chains but could pose risks of monopolization.

Conclusion

The global aminophylline supply landscape reflects a robust network of suppliers, chiefly in India and China, supported by quality-focused European providers. As demand persists and regulatory standards tighten, pharmaceutical companies need to strategically select suppliers based on quality, compliance, capacity, and cost. Ensuring a diversified supplier base mitigates risks associated with geopolitical tensions, raw material shortages, and regulatory hurdles.

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Key Takeaways

• Indian and Chinese API manufacturers dominate aminophylline supply, focusing on cost-effective, high-volume production aligned with international standards.

• Regulatory compliance (WHO-GMP, cGMP, EU-GMP, FDA standards) is critical when selecting suppliers to ensure market access and product quality.

• Supply chain resilience requires diversification, especially amid geopolitical and pandemic-related disruptions.

• Technological advances and sustainability initiatives are shaping the future of aminophylline manufacturing.

• Major European firms provide high-quality APIs for regulated markets but at higher price points, emphasizing quality over cost.

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FAQs

1. Who are the leading global suppliers of aminophylline API?
Major suppliers include Indian companies like Sun Pharma, Aurobindo Pharma, and Lupin; Chinese manufacturers such as NCPC and Xinhua; and European firms like Siegfried and CordenPharma, known for high-quality APIs.

2. What factors influence the choice of aminophylline suppliers?
Key factors include regulatory compliance, manufacturing capacity, quality assurance, cost competitiveness, supply reliability, and adherence to environmental standards.

3. How does regulation impact aminophylline API suppliers?
Regulatory frameworks dictate manufacturing practices, quality standards, and inspection requirements. Suppliers compliant with cGMP, WHO-GMP, or EU-GMP are prioritized for regulated markets to ensure product safety and efficacy.

4. What are the current supply chain risks associated with aminophylline?
Risks involve capacity constraints, geopolitical tensions, raw material shortages, transportation disruptions, and regulatory changes, which can impact product availability and pricing.

5. What future trends could affect aminophylline supply?
Emerging trends include increased localization of manufacturing, adoption of green chemistry practices, technological innovations in synthesis, and industry consolidation, all shaping the global supply landscape.

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References

1. "Global API Market Analysis," pharmaceuticalreview.com, 2022.
2. World Health Organization (WHO). "Good Manufacturing Practices (GMP): Pharmaceutical APIs," 2021.
3. US Food and Drug Administration (FDA). "Guidance for Industry on API Quality," 2020.
4. "Indian API Industry Overview," Indian Pharmaceutical Alliance, 2021.
5. "China Pharmaceutical Industry Report," China National Pharmaceutical Administration, 2022.