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Suppliers and packagers for generic pharmaceutical drug: FLUNISOLIDE
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FLUNISOLIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bausch | FLUNISOLIDE | flunisolide | SPRAY, METERED;NASAL | 074805 | ANDA | Bausch & Lomb Incorporated | 24208-344-25 | 1 BOTTLE, PUMP in 1 CARTON (24208-344-25) / 25 mL in 1 BOTTLE, PUMP | 2002-02-20 |
| Bausch | FLUNISOLIDE | flunisolide | SPRAY, METERED;NASAL | 074805 | ANDA | Oceanside Pharmaceuticals | 68682-344-25 | 1 BOTTLE, PUMP in 1 CARTON (68682-344-25) / 25 mL in 1 BOTTLE, PUMP | 2025-06-01 |
| Riconpharma Llc | FLUNISOLIDE | flunisolide | SPRAY, METERED;NASAL | 207802 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-317-25 | 1 BOTTLE, PUMP in 1 CARTON (50742-317-25) / 25 mL in 1 BOTTLE, PUMP | 2022-06-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Flunisolide
Introduction
Flunisolide is a potent corticosteroid primarily used in the management of asthma and allergic rhinitis through inhalation and nasal spray formulations. As a synthetic glucocorticoid, it exerts anti-inflammatory effects by inhibiting multiple types of inflammatory cells and mediators. The manufacture and supply chain of flunisolide are crucial for pharmaceutical companies, healthcare providers, and regulatory bodies. This article provides a comprehensive overview of key suppliers involved in the production and distribution of flunisolide, emphasizing their roles, manufacturing capacity, regulatory compliance, and market presence.
Overview of Flunisolide Manufacturing
The production of flunisolide involves complex chemical synthesis processes requiring specialized expertise and equipment. Major pharmaceutical companies and chemical manufacturers globally supply raw materials, intermediates, and finished formulations. Reliable suppliers ensure the drug's quality, safety, and compliance with regulatory standards, such as those set by the FDA, EMA, and other global authorities.
Major Pharmaceutical Suppliers
1. CIPLA Limited
Overview:
An Indian multinational pharmaceutical company, Cipla ranks among the world's prominent suppliers of respiratory and corticosteroid drugs. Cipla offers flunisolide in various formulations, including inhalers and nasal sprays.
Manufacturing & Supply Capabilities:
Cipla’s manufacturing facilities adhere to cGMP standards, ensuring high-quality production. The company supplies both domestic Indian markets and export regions, including the USA, Europe, Africa, and Southeast Asia.
Regulatory Compliance:
Cipla maintains stringent quality controls aligned with international standards, including FDA approval for specific product lines.
2. Teva Pharmaceutical Industries Ltd.
Overview:
An Israeli multinational, Teva is a global leader in generic pharmaceuticals and biosynthetic drugs. Teva produces inhaled corticosteroids, including flunisolide, through strategic partnerships and in-house manufacturing.
Supply Chain & Distribution:
Teva’s extensive global network ensures broad distribution channels, serving hospitals, clinics, and wholesalers worldwide.
Regulatory & Quality Assurance:
Teva’s manufacturing facilities conform to cGMP standards, with certifications from major regulatory bodies, ensuring product consistency and safety.
3. Mylan (Now part of Viatris)
Overview:
Mylan, recently merged with Pfizer's Upjohn to form Viatris, has a significant presence in the inhaled corticosteroid market. They produce flunisolide nasal sprays, targeting allergic rhinitis.
Manufacturing & Distribution:
Viatris leverages global manufacturing assets for consistent supply, particularly to North American and European markets.
Regulatory Profile:
Viatris complies with strict regulatory frameworks, including FDA and EMA approvals, ensuring product quality.
Specialized Chemical Manufacturers & Raw Material Suppliers
4. Sanofi Winthrop Industries
Role:
Supplies key intermediates and active pharmaceutical ingredients (APIs) for corticosteroid synthesis.
Quality & Compliance:
Sanofi’s suppliers meet cGMP standards, ensuring raw material purity necessary for pharmaceutical-grade flunisolide.
5. Hikal Ltd.
Role:
An Indian chemical manufacturer specializing in fine chemical synthesis for pharmaceuticals, supplying intermediates used in flunisolide production.
Regulatory Standards:
Hikal operates under strict quality controls, supplying APIs and intermediates to global markets.
Emerging and Contract Manufacturing Organizations (CMOs)
6. Biocon Limited
Overview:
An Indian biopharmaceutical CMOs interface for inhaled corticosteroids, including flunisolide formulations, expanding global supply capacity.
Capabilities:
Biocon’s manufacturing facilities are certified under various global regulatory agencies, enabling export and local market penetration.
7. Dr. Reddy’s Laboratories
Role:
Provides manufacturing services and formulations of corticosteroid-based drugs, including flunisolide, to increase global supply flexibility.
Global Market Dynamics & Supplier Considerations
The supply chain for flunisolide faces challenges such as raw material purity, geopolitical factors, regulatory changes, and manufacturing capacity constraints. Key considerations for buyers include:
- Regulatory Compliance: Ensuring suppliers adhere to cGMP, FDA, EMA, and other certifications to prevent supply disruptions.
- Quality Assurance: Verifying batch-to-batch consistency and raw material integrity.
- Capacity & Scalability: Confirming suppliers can meet current and future demand, especially during pandemic-related supply shocks or patent expirations.
- Cost & Logistics: Balancing procurement costs with reliable delivery timelines.
Conclusion
The supply landscape for flunisolide comprises established pharmaceutical giants like Cipla, Teva, and Viatris, complemented by specialized chemical manufacturers such as Sanofi and Hikal. Contract manufacturing organizations further bolster global production capabilities, enabling consistent supply to meet market demands. Companies seeking to procure flunisolide should prioritize regulatory compliance, quality standards, and supply chain resilience to mitigate risks and ensure uninterrupted access to this essential respiratory medication.
Key Takeaways
- Major Suppliers: Cipla, Teva, and Viatris dominate the global flunisolide market, offering various formulations with extensive distribution networks.
- Regulatory Standards: Ensuring suppliers comply with cGMP and have necessary certifications (FDA, EMA) is crucial for quality assurance.
- Supply Chain Risks: Raw material availability, geopolitical issues, and regulatory changes may impact supply; diversification is advisable.
- Emerging Players: Indian CMOs like Biocon and Dr. Reddy’s enhance global manufacturing capacity, supporting increased demand.
- Procurement Strategy: Emphasize supplier reliability, quality control, and regulatory compliance for sustained supply security.
FAQs
Q1: Which companies are the leading global suppliers of flunisolide?
A: Cipla, Teva, and Viatris are among the top global suppliers, offering various inhalation and nasal spray formulations.
Q2: What regulatory standards should suppliers of flunisolide meet?
A: Suppliers should adhere to current Good Manufacturing Practices (cGMP), with certifications like FDA approval, EMA compliance, and WHO prequalification.
Q3: Are there regional differences in flunisolide suppliers?
A: Yes. While global companies supply worldwide, regional manufacturers like Cipla (India) predominantly serve local markets, though they often export.
Q4: What are the primary challenges in the supply of flunisolide?
A: Challenges include raw material shortages, geopolitical disruptions, manufacturing capacity constraints, and regulatory compliance complexities.
Q5: How can pharmaceutical companies mitigate supply risks for flunisolide?
A: Diversify supplier base, establish long-term contracts, maintain quality audits, and monitor regulatory updates to ensure continuous supply.
References
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