Suppliers and packagers for generic pharmaceutical drug: LEVALBUTEROL TARTRATE
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LEVALBUTEROL TARTRATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Lupin | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730 | NDA AUTHORIZED GENERIC | Actavis Pharma, Inc. | 0591-2927-54 | 1 INHALER in 1 CARTON (0591-2927-54) / 200 AEROSOL, METERED in 1 INHALER | 2016-10-03 |
| Lupin | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730 | NDA | Lupin Pharmaceuticals, Inc. | 27437-056-01 | 1 INHALER in 1 CARTON (27437-056-01) / 200 AEROSOL, METERED in 1 INHALER | 2023-11-10 |
| Lupin | XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730 | NDA AUTHORIZED GENERIC | Praxis, LLC | 59368-410-01 | 1 INHALER in 1 CARTON (59368-410-01) / 200 AEROSOL, METERED in 1 INHALER | 2016-10-03 |
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Suppliers for the Pharmaceutical Drug: Levalbuterol Tartrate
Introduction
Levalbuterol tartrate, marketed primarily as a bronchodilator, is a pivotal medication in managing respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). Its active S-enantiomer, levalbuterol, offers rapid relief from bronchospasm with fewer side effects compared to its racemic mixture, racemic albuterol. Securing reliable suppliers for levalbuterol tartrate is critical for pharmaceutical companies, healthcare providers, and distributors. This comprehensive analysis profiles leading suppliers, examines market dynamics, and highlights considerations for sourcing this essential medication.
Overview of Levalbuterol Tartrate
Levalbuterol tartrate is the (R)-enantiomer of albuterol, recognized for its selectivity in β2-adrenergic receptors, facilitating smooth muscular relaxation in airway passages. Its patented formulations are available under numerous branded and generic variants globally. The raw material, levalbuterol tartrate, is synthesized via chiral resolution or asymmetric synthesis, necessitating specialized manufacturing processes. The demand surge correlates with respiratory illness prevalence and global health initiatives emphasizing fast-acting inhalation therapies.
Major Suppliers of Levalbuterol Tartrate
1. Novartis (Sandoz Division)
As a leading innovator and manufacturer, Novartis Sandoz supplies pharmaceutical-grade levalbuterol tartrate globally. Their manufacturing facilities are compliant with Good Manufacturing Practice (GMP) standards, ensuring high purity and consistency. Novartis's extensive distribution network allows for timely delivery across North America, Europe, and Asia.
2. Cipla Ltd.
An Indian multinational pharmaceutical company, Cipla is among the primary generic manufacturers offering levalbuterol tartrate. Known for its affordable pricing and robust supply chain, Cipla's products are widely used across emerging markets, particularly in Asia and Africa. Their facilities are approved by major regulatory bodies, including the USFDA and EMA.
3. Teva Pharmaceutical Industries Ltd.
Teva produces both active pharmaceutical ingredients (APIs) and finished drug formulations, including levalbuterol tartrate. Their established API manufacturing plants adhere to international standards, making them a reliable supplier for generic drug companies and contract manufacturing organizations (CMOs).
4. Sun Pharmaceutical Industries Ltd.
Sun Pharma offers pharmaceutical-grade levalbuterol tartrate, often in partnership with local distributors. Their focus on quality control and cost-effective manufacturing makes them a significant player, especially in Asian and Middle Eastern markets.
5. Chengdu Tiantaishan Pharmaceutical Co., Ltd.
Based in China, Chengdu Tiantaishan specializes in the synthesis of respiratory API compounds, including levalbuterol tartrate. They supply both domestic and international markets, emphasizing competitive pricing and rapid production capabilities.
6. Aurobindo Pharma
Aurobindo is a prominent Indian API manufacturer with a portfolio including levalbuterol tartrate. Their facility accreditation and strategic partnerships facilitate export to major regions such as North America and Europe.
Emerging and Specialty Suppliers
Beyond these giants, several smaller or regional manufacturers have entered the market, often offering bulk APIs for custom formulations. Notable among these are:
- Hepalink Pharmaceutical Group: Based in China, offering cost-effective APIs.
- Minghuan Pharmaceutical: Focused on respiratory API manufacturing in Asia.
- Bachem AG: Specializes in chiral synthesis, including enantiomer-specific APIs, potentially providing custom levalbuterol tartrate synthesis.
Market Dynamics Influencing Supplier Selection
The global supply chain for levalbuterol tartrate is influenced by various factors:
- Regulatory Compliance: Suppliers must adhere to stringent standards such as USFDA, EMA, or WHO-GMP.
- Manufacturing Capacity and Lead Time: High-demand periods require robust production capabilities.
- Pricing and Cost Efficiency: Competitive pricing is critical, especially for generic manufacturers targeting emerging markets.
- Quality and Consistency: Purity levels, enantiomeric excess, and stability profiles dictate supplier preference.
- Geographical Considerations: Proximity to markets influences logistics, import/export regulations, and price competitiveness.
Regulatory and Quality Considerations
Stakeholders sourcing levalbuterol tartrate must validate suppliers through quality certifications, batch testing reports, and supplier audits. The active APIs are subjected to strict quality control to prevent impurities, enantiomeric contamination, and ensure bioequivalence.
Supply Chain Challenges and Mitigation Strategies
- Raw Material Availability: Chiral raw materials for synthesis can be constrained, affecting supply continuity.
- Regulatory Variations: Differing standards across regions necessitate thorough compliance checks.
- Price Fluctuations: Market volatility in raw material costs impacts API pricing.
- Counterfeit Risks: The high demand for respiratory drugs increases counterfeit risks; verified suppliers and authenticated documentation are essential.
Mitigation involves establishing cross-sourcing agreements, maintaining inventory buffers, and fostering close supplier relationships.
Conclusion
The supply landscape for levalbuterol tartrate comprises a blend of global pharmaceutical giants and regional manufacturers, each with distinct advantages. Successful sourcing hinges on stringent quality assessments, regulatory compliance, and logistical efficiency. As respiratory health demands intensify, ensuring an uninterrupted, high-quality supply of levalbuterol tartrate remains paramount for pharmaceutical entities and healthcare providers.
Key Takeaways
- Leading suppliers include Novartis Sandoz, Cipla, Teva, Sun Pharma, and Chengdu Tiantaishan, with others emerging regionally.
- Quality, regulatory compliance, and manufacturing capacity are critical selection criteria.
- Global supply chains are susceptible to raw material shortages, regulatory changes, and market volatility.
- Strategic diversification of suppliers can mitigate risks and enhance supply security.
- Rigorous due diligence, including validation and quality audits, safeguards against counterfeit and substandard products.
Frequently Asked Questions (FAQs)
1. What are the key factors to consider when selecting a supplier for levalbuterol tartrate?
Quality assurance, regulatory compliance (e.g., FDA, EMA), manufacturing capacity, pricing, and supply chain reliability are paramount.
2. Is levalbuterol tartrate available from generic manufacturers?
Yes, several generic producers, including Cipla and Aurobindo, supply levalbuterol tartrate, offering cost-effective options for global markets.
3. How does the manufacturing process impact the quality of levalbuterol tartrate?
Enantiomeric purity and synthesis method (chiral resolution vs. asymmetric synthesis) influence API efficacy, safety, and regulatory approval.
4. Are there regional differences in supplier quality standards?
Yes, suppliers from developed countries typically adhere to stricter GMP standards; however, well-regulated manufacturers in emerging markets also maintain high quality levels with proper validation.
5. How can healthcare companies ensure a reliable supply of levalbuterol tartrate?
Establish multiple sourcing agreements, conduct regular quality audits, maintain inventory buffers, and foster strong relationships with reputable suppliers.
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