Suppliers and packagers for generic pharmaceutical drug: theophylline

theophylline

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Rhodes Pharms	THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	040086	ANDA	Rhodes Pharmaceuticals L.P.	42858-701-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42858-701-01)	2012-02-02
Mpp Pharma	THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	040560	ANDA	Nostrum Laboratories, Inc.	29033-001-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29033-001-01)	2020-01-23
Mpp Pharma	THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	040560	ANDA	Nostrum Laboratories, Inc.	29033-002-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (29033-002-01)	2020-01-23
Mpp Pharma	THEOPHYLLINE	theophylline	TABLET, EXTENDED RELEASE;ORAL	040560	ANDA	Golden State Medical Supply, Inc.	51407-318-01	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51407-318-01)	2006-04-21

Suppliers for the Pharmaceutical Drug: Theophylline

Last updated: July 29, 2025

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Introduction

Theophylline, a methylxanthine derivative, has long been a mainstay in the treatment of respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). Despite its age, it remains relevant owing to its bronchodilator properties, affordability, and established safety profile when monitored appropriately. The global landscape of theophylline suppliers is characterized by a diverse mix of generic manufacturers, contract manufacturing organizations (CMOs), and specialty pharmaceutical companies. This article provides an in-depth analysis of key suppliers, market dynamics, and strategic considerations for stakeholders in the pharmaceutical supply chain.

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Global Supply Landscape

Manufacturers of Theophylline API

Active pharmaceutical ingredient (API) suppliers are the backbone of the theophylline supply chain. They produce high-purity APIs that are utilized by finished dose form (FDF) manufacturers. Notably, China and India dominate the API production landscape, owing to their large-scale manufacturing capabilities, cost advantages, and regulatory frameworks conducive to bulk production.

1. Chinese API Manufacturers
   Chinese producers are among the largest global suppliers of theophylline API. Companies such as Zhejiang NHU Co., Ltd., and Zhejiang Huahai Pharmaceutical Co., Ltd. manufacture APIs with compliance certifications including Good Manufacturing Practices (GMP). China's API export volumes for methylxanthines are significant, supplying markets worldwide, particularly to India, Southeast Asia, and increasingly to non-regulated markets.

2. Indian API Manufacturers
   India boasts a robust API manufacturing sector with companies like Solara Active Pharma Sciences Ltd., and Jubilant Life Sciences (now Jubilant Pharma), which produce high-quality theophylline APIs compliant with international standards. Indian APIs are widely used by domestic formulations and exported globally, benefiting from established regulatory familiarity and cost efficiencies.

3. European and North American Producers
   While less prevalent, a niche exists for high-purity APIs from European and North American manufacturers. Companies such as Thermo Fisher Scientific and Lonza provide specialty APIs suitable for research or high-quality formulations, although their market share for bulk theophylline is limited by higher costs.

Finished Dosage Form Manufacturers

Once APIs are procured, finished products are assembled and marketed across various regions. Several key players dominate this space:

• Teva Pharmaceuticals
  One of the most prominent generic drug manufacturers globally, Teva supplies theophylline tablets and syrup to multiple markets. Their extensive distribution network ensures wide availability, particularly in the United States and Europe.

• Mylan (now part of Viatris)
  Viatris continues the legacy of Mylan with a broad portfolio, including sustained-release and immediate-release theophylline formulations. Their manufacturing facilities in India and Europe reinforce global supply stability.

• Sandoz (a Novartis division)
  Sandoz manufactures theophylline products mainly aimed at markets requiring lower-cost generics, with supply chains revolving around their European and Asian manufacturing sites.

• Other Notable Brands
  Local and regional pharmaceutical companies in Latin America, Asia, and Eastern Europe also produce theophylline formulations, often under private-label agreements or regional branding.

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Supply Chain Dynamics and Market Drivers

Factors Influencing Supply

• Regulatory Environment
  Compliance with GMP standards and regulatory approvals (FDA, EMA, etc.) are prerequisites for API and finished product manufacturing. Variations in regulatory standards influence supplier selection and market access.

• Raw Material Cost and Availability
  Raw material costs impact API pricing and supply continuity. The predominance of Chinese and Indian suppliers reflects their ability to scale and maintain low costs.

• Manufacturing Capacity and Lead Time
  API capacity constraints or disruptions, as seen during global events like the COVID-19 pandemic, can lead to supply shortages. Strategic stockpiling and diversified sourcing mitigate risks.

• Quality and Certification Standards
  Growing demand for high-quality APIs and formulations has driven suppliers to seek or upgrade to certification standards such as ISO, GMP, and pharmacopoeial compliance (USP, EP).

Market Demand and Therapeutic Use

Despite newer therapies for respiratory diseases, theophylline’s low cost and established efficacy keep it in demand, especially in developing markets and for patients with specific treatment needs. The global market for theophylline is expected to grow marginally, driven by emerging markets and ongoing use in resource-limited settings.

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Strategic Considerations for Stakeholders

• Sourcing Diversification
  Reliance on a limited number of API suppliers, especially from China and India, poses supply risks. Engaging multiple suppliers across regions reduces vulnerability.

• Quality Assurance
  Ensuring API compliance with pharmaceutical standards is crucial. Regular audits, supplier qualification, and rigorous quality checks safeguard product integrity.

• Regulatory Vigilance
  Monitoring evolving regulatory requirements aids in maintaining market access, particularly as authorities tighten standards around manufacturing practices and documentation.

• Cost Optimization
  Negotiating competitive procurement contracts and leveraging the scale efficiencies of large producers can optimize costs without compromising quality.

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Future Outlook and Trends

• Regulatory Harmonization and Certification
  Continued harmonization efforts aim to streamline approvals and facilitate cross-border trade of APIs. Suppliers investing in certification and quality management systems will likely gain competitive advantage.

• Sustainability and Green Manufacturing
  Environmental concerns and sustainable practices are gaining prominence. Suppliers adopting green chemistry and environmental management systems may better align with future market expectations.

• Technological Advancements
  Process improvements such as continuous manufacturing and biotechnological innovations could influence future API production, ensuring higher yields and lower costs.

• Emerging Suppliers
  New entrants from emerging economies may challenge traditional players, offering competitive prices and supply agility.

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Key Takeaways

• The global supply of theophylline hinges predominantly on Asian API producers, notably Chinese and Indian manufacturers, due to their capacity, cost efficiency, and regulatory compliance.

• Major finished formulation suppliers include Teva, Viatris, and Sandoz, with regional and local manufacturers supplementing supply in various markets.

• Supply chain resilience depends on diversification, quality assurance, and monitoring regulatory trends; disruptions remain a key risk.

• Market demand persists primarily in emerging markets and resource-limited settings, sustaining the relevance of theophylline despite newer therapies.

• Strategic procurement, sustainable practices, and technological innovation are essential for stakeholders seeking competitive advantage.

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FAQs

1. Who are the largest global suppliers of theophylline API?
Chinese companies like Zhejiang NHU and Indian firms such as Solara Active Pharma Sciences lead in API production, leveraging large manufacturing capacities and cost advantages.

2. Are there high-quality alternative suppliers outside Asia?
European and North American manufacturers provide specialty or high-purity APIs, but their bulk supply is limited and costlier compared to Asian producers.

3. How do regulatory standards impact theophylline supply?
Compliance with GMP and pharmacopeial standards influences supplier credibility and market access. Regulatory non-compliance can lead to supply disruptions or market bans.

4. What are the main risks in the theophylline supply chain?
Raw material shortages, regulatory shifts, geopolitical tensions, and manufacturing disruptions pose risks. Diversifying suppliers reduces vulnerability.

5. What trends could shape the future of theophylline supply?
Increased emphasis on sustainability, technological innovations in manufacturing, and emerging supplier markets are likely to influence the supply landscape.

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Sources

1. [1] European Medicines Agency, "Theophylline," https://www.ema.europa.eu/en/medicines/human/EPAR/theophylline (accessed February 2023).
2. [2] US Food and Drug Administration, "Approved Drug Products with Therapeutic Equivalence Evaluations," 2022.
3. [3] Zhejiang NHU Co., Ltd. Annual Report, 2022.
4. [4] Solara Active Pharma Sciences Ltd., Company Profile, 2022.
5. [5] MarketWatch, "Global Theophylline Market," 2022.