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Suppliers and packagers for elixophyllin
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elixophyllin
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Solis Pharms | ELIXOPHYLLIN | theophylline | SOLUTION, ELIXIR;ORAL | 085186 | ANDA | Nostrum Laboratories, Inc. | 70408-644-34 | 473 mL in 1 BOTTLE (70408-644-34) | 2009-10-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ELIXOPHYLLIN
Introduction
Elixophyllin, commonly known by its generic name, theophylline, is a bronchodilator used to treat respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). Its efficacy in airway relaxation positions it as a key drug in respiratory therapy. The global demand for Elixophyllin—either in its branded form or as a generic—is driven by the rising prevalence of respiratory ailments, growth in pharmaceutical manufacturing, and ongoing research into respiratory medicines. This article examines the key suppliers and manufacturing sources of Elixophyllin, providing insights vital for stakeholders across the pharmaceutical supply chain.
Manufacturers and Suppliers of Elixophyllin
1. Origin and Global Production Landscape
Elixophyllin is primarily manufactured by pharmaceutical companies that possess the chemical synthesis capabilities for theophylline. While originally developed in the early 20th century, it remains available both as a branded product (Elixophyllin, produced by Iroko Pharmaceuticals) and in generic formulations produced worldwide (e.g., by Teva, Mylan, and Sun Pharma). The raw material for manufacturing the drug is theophylline, a methylxanthine compound, which is synthesized either via chemical processes or extracted from natural sources such as cocoa plants.
2. Major Pharmaceutical Companies Producing Elixophyllin
a. Iroko Pharmaceuticals
- Product: Elixophyllin (branded formulation)
- Market Focus: U.S. and select international markets
- Supply Chain: Iroko Pharmaceuticals manufactures Elixophyllin with a focus on high-quality standards, ensuring potency and stability. The company may also source raw theophylline from global chemical suppliers to meet production demands.
b. Mylan (now part of Viatris)
- Product: Generic theophylline products, including tablets and solutions
- Supply Chain Role: Mylan is a significant supplier of generic theophylline formulations, often distributed worldwide, including emerging markets.
c. Teva Pharmaceuticals
- Product: Generic theophylline formulations
- Distribution: As one of the world's largest generic manufacturers, Teva supplies Elixophyllin equivalents globally, often focusing on affordability and wide accessibility.
d. Sun Pharmaceutical Industries
- Product: Theophylline extended-release formulations
- Market Use: Predominantly in Asian, African, and Latin American markets.
e. Other Regional Suppliers
Many regional pharmaceutical companies also produce theophylline-based medications under various brand names. Examples include Lupin, Aurobindo Pharma, and Cipla, which manufacture both branded and generic formulations fulfilling local demands.
3. Raw Material Suppliers of Theophylline
The active pharmaceutical ingredient (API) for Elixophyllin is theophylline, whose procurement is critical for manufacturers. Leading API suppliers include:
- Catalent Pharma Solutions
- Xianju Pharmaceutical
- Hubei Jushunda Pharmaceutical
- Hainan Pharmaceutical
These companies offer bulk theophylline, complying with Good Manufacturing Practices (GMP) standards, and serve as the backbone of the supply chain for finished Elixophyllin products.
Supply Chain Dynamics and Market Factors
A. Supply Chain Complexity
The supply chain for Elixophyllin encompasses raw material sourcing, API manufacturing, formulation process, and distribution. Disruptions at any stage—such as API shortages, regulatory issues, or geopolitical factors—can impact availability.
B. Regulatory Environment
Regulatory authorities like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and local agencies enforce strict quality standards for API and finished products. Suppliers meeting these standards often possess certifications such as GMP compliance and ISO accreditation.
C. Impact of API Shortages
Recent years have experienced API supply constraints due to environmental regulations, manufacturing issues, and supply chain disruptions (notably during the COVID-19 pandemic). These shortages affect generic producers' ability to meet demand for Elixophyllin worldwide.
D. Geographical Market Distribution
While the U.S. and Europe primarily rely on branded formulations, emerging markets depend heavily on cost-effective generics from Asian manufacturers. The presence of multiple regional API and formulation manufacturers ensures broader access but amplifies supply chain complexity.
Key Considerations for Buyers and Stakeholders
- Quality Assurance: Confirm API suppliers' GMP compliance and regulatory approvals.
- Supply Chain Diversification: Engage with multiple suppliers to minimize risk associated with regional disruptions.
- Pricing Dynamics: Leverage the competitive landscape among generic manufacturers to optimize procurement costs.
- Regulatory Registration: Ensure finished products are registered with relevant authorities, maintaining continuous market access.
Conclusion
The supply of Elixophyllin hinges upon a global network of API producers, generic pharmaceutical companies, and regulating agencies. Major players like Mylan, Teva, and Sun Pharma dominate the manufacturing and distribution landscape, sourcing API from a combination of regional and international suppliers. As demand continues to grow amid evolving market dynamics, ensuring supply chain resilience, regulatory compliance, and quality assurance remains paramount for stakeholders seeking reliable access to Elixophyllin.
Key Takeaways
- Primary suppliers of Elixophyllin include major generic firms such as Mylan, Teva, and Sun Pharma; branding is handled mainly by Iroko Pharmaceuticals.
- Theophylline API sourcing is diversified globally, with prominent API manufacturers capable of meeting large-scale demand.
- Supply chain disruptions, especially API shortages, pose a risk but can be mitigated through strategic supplier diversification.
- Regulatory standards significantly influence supplier qualification and market access, emphasizing the importance of GMP compliance.
- The rising global prevalence of respiratory diseases ensures sustained demand for both branded and generic Elixophyllin formulations.
FAQs
1. Who are the leading manufacturers of Elixophyllin globally?
Major manufacturers include Iroko Pharmaceuticals (branded), alongside generic producers such as Mylan (Viatris), Teva Pharmaceuticals, and Sun Pharma. They source theophylline API from a diverse range of global suppliers.
2. Where does the theophylline raw material originate?
Theophylline is primarily synthesized chemically by API manufacturers, with some natural extraction methods from cocoa or tea plants used in niche applications, although chemical synthesis remains predominant.
3. Are there regional differences in Elixophyllin suppliers?
Yes. North America and Europe mainly rely on branded formulations from established pharmaceutical companies, whereas Asia, Africa, and Latin America depend heavily on generic producers sourced from regional API manufacturers.
4. How does API supply impact drug availability?
API shortages can lead to supply chain disruptions, affecting manufacturing capacity and leading to possible shortages of Elixophyllin in certain markets—especially when sourcing relies on limited API manufacturers.
5. What should buyers consider when sourcing Elixophyllin?
Buyers must prioritize GMP-certified suppliers, assess regulatory statuses, diversify procurement sources to mitigate risk, and stay informed about market and regulatory developments affecting API supply and drug approval.
References
[1] U.S. Food and Drug Administration. "Approved Drug Products with Therapeutic Equivalence Evaluations."
[2] European Medicines Agency. "Pharmaceutical Industry Data."
[3] IQVIA. "Global Pharmaceutical Market Analysis."
[4] Pharma Intelligence. "API Market Trends and Supply Chain Developments."
[5] Mylan, Teva, Sun Pharma official websites and product catalogs.
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