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Suppliers and packagers for SARAFEM
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SARAFEM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Eli Lilly And Co | SARAFEM | fluoxetine hydrochloride | CAPSULE;ORAL | 018936 | NDA | Dista Products Company | 0777-3104-02 | 100 CAPSULE in 1 BOTTLE (0777-3104-02) | 1993-01-13 |
| Eli Lilly And Co | SARAFEM | fluoxetine hydrochloride | CAPSULE;ORAL | 018936 | NDA | Dista Products Company | 0777-3105-02 | 100 CAPSULE in 1 BOTTLE (0777-3105-02) | 1988-02-01 |
| Eli Lilly And Co | SARAFEM | fluoxetine hydrochloride | CAPSULE;ORAL | 018936 | NDA | Dista Products Company | 0777-3105-30 | 30 CAPSULE in 1 BOTTLE (0777-3105-30) | 1988-02-01 |
| Eli Lilly And Co | SARAFEM | fluoxetine hydrochloride | CAPSULE;ORAL | 018936 | NDA | Dista Products Company | 0777-3107-30 | 30 CAPSULE in 1 BOTTLE (0777-3107-30) | 1999-06-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: SARAFEM
Introduction
SARAFEM, a branded pharmaceutical product with the generic name fluoxetine, is widely used in the treatment of depression, obsessive-compulsive disorder, bulimia nervosa, and panic disorder. As an SSRI (selective serotonin reuptake inhibitor), its demand spans globally, creating a diverse supply chain consisting of various manufacturers, distributors, and importers. This article examines the landscape of suppliers involved in the manufacturing and distribution of SARAFEM, analyzes their roles, and discusses factors influencing supply chain stability and reliability.
Overview of SARAFEM and Market Dynamics
SARAFEM (fluoxetine hydrochloride) has remained a staple in psychopharmacology since its approval, with its primary production concentrated among major pharmaceutical companies. The drug’s patent exclusivity ended years ago, allowing multiple generic manufacturers to produce equivalent formulations, which has expanded the supplier base considerably.
The competitive landscape is characterized by prominent multinational pharmaceutical giants and numerous regional and local manufacturers. The increasing availability of generic versions has driven prices downward, fueling demand and prompting a robust supply chain network. Regulatory frameworks, patent laws, manufacturing quality standards, and geopolitical factors shape the landscape of SARAFEM suppliers.
Major Pharmaceutical Manufacturers
1. Eli Lilly and Company
As the originator of fluoxetine, Eli Lilly holds the initial patent and controlled production during the exclusive patent period. Though patent exclusivity expired in many countries, Eli Lilly remains involved as a key supplier in some jurisdictions through licensing agreements. Their manufacturing facilities uphold high regulatory standards, ensuring product quality.
2. Teva Pharmaceutical Industries Ltd.
Teva is one of the world's largest generic pharmaceutical manufacturers, producing fluoxetine in various dosages. Their extensive global manufacturing network allows for widespread distribution and price competitiveness. Teva’s compliance with Good Manufacturing Practices (GMP) is a critical factor in their supplier reputation.
3. Torrent Pharmaceuticals
A major player in India and emerging markets, Torrent Pharmaceuticals manufactures generic fluoxetine formulations for domestic and export markets. Their focus on quality and affordability positions them as a significant regional supplier.
4. Mylan (Now part of Viatris)
Mylan’s wide portfolio includes fluoxetine generics supplied globally. Their manufacturing facilities are certified by major regulatory agencies such as the FDA and EMA, which adds confidence to their supply reliability.
5. Sun Pharmaceutical Industries Ltd.
Based in India, Sun Pharma produces fluoxetine for global markets, including the US and Europe. Their extensive R&D and manufacturing infrastructure enable consistent supply.
Regional and Local Suppliers
In addition to multinational corporations, country-specific manufacturers play critical roles, especially in developing markets or regions with high demand. Examples include:
- Alkem Laboratories (India): Supplies generic fluoxetine formulations.
- Lupin Pharmaceuticals (India): Provides affordable fluoxetine options for emerging markets.
- Prodessa (Brazil): Local manufacturer serving Latin American markets.
- Chongqing Galaxy Pharmaceutical (China): Produces fluoxetine for the domestic Chinese market.
The diversity of regional suppliers ensures broader geographic access, though variability in manufacturing quality and regulatory oversight can influence supply stability.
Distribution Channels and Supply Chain Considerations
The supply chain involves multiple layers, including raw material suppliers, formulation manufacturers, and distributors. The raw materials—primarily chemical intermediates used to synthesize fluoxetine—are sourced from specialized chemical manufacturers worldwide, predominantly in China and India.
Distributors and wholesalers facilitate the movement from manufacturing units to retail pharmacies, hospitals, and clinics. Regulatory approvals, import-export licensing, and quality certifications significantly influence the efficiency of these channels.
Supply chain disruptions—such as manufacturing delays, raw material shortages, geopolitical conflicts, or regulatory non-compliance—can impact the availability of SARAFEM in different markets. Manufacturers maintaining diversified supply sources and adhering to strict quality standards mitigate these risks.
Regulatory and Patent Landscape
Post-patent expiration, multiple manufacturers qualify for producing generic fluoxetine. Regulatory agencies like the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency) enforce rigorous standards, supplying approvals that influence market entry and supplier credibility.
However, the regulatory environment can also serve as a barrier to new entrants, with countries having varying standards affecting global supply consistency. Patent litigation, licensing agreements, and regional exclusivity rights further shape the supplier matrix.
Future Trends in SARAFEM Supply
Emerging trends impacting the supplier landscape include:
- Increasing manufacturing capacity in Asia: Investment in production facilities in India and China boosts regional supply resilience.
- Quality assurance initiatives: Standards like EMA and FDA certifications are increasingly prioritized.
- Supply chain digitalization: Real-time monitoring and traceability are enhancing supply chain transparency.
- Sustainable sourcing: Growing emphasis on environmentally friendly manufacturing practices can influence supplier selection.
Key Factors Influencing Supplier Selection
- Regulatory Compliance: Suppliers must meet GMP and other regulatory standards.
- Manufacturing Capacity and Scalability: Ability to meet global demand fluctuations.
- Quality Assurance and Certification: Consistent quality outputs mitigate supply risks.
- Price Competitiveness: Market forces favor cost-effective suppliers.
- Supply Chain Reliability: Historical delivery performance, diversified sourcing.
- Geopolitical Stability: Political conditions influence manufacturing and distribution ease.
Conclusion
The supply of SARAFEM is sustained by a dynamic network of global and regional manufacturers, with major multinational corporations dominating the landscape. The expiration of patent protections has democratized production, enabling a broad array of suppliers to serve diverse markets. Ensuring supply chain robustness requires careful scrutiny of regulatory compliance, manufacturing capacity, and geopolitical factors.
Business professionals involved in procurement, distribution, or market analysis should prioritize partnerships with suppliers demonstrating consistent quality, regulatory adherence, and resilient logistics. As the pharmaceutical landscape continues to evolve, ongoing monitoring of global manufacturing trends and regulatory developments remains essential.
Key Takeaways
- Diverse Supplier Base: The SARAFEM market comprises major global generic manufacturers and regional producers, ensuring broad supply but requiring vigilant quality assessment.
- Regulatory Standards: Compliance with GMP and regulatory approvals critically influence supplier credibility and supply stability.
- Regional Manufacturing Hubs: India and China are dominant in chemical synthesis and formulation, boosting regional availability.
- Supply Chain Risks: Disruptions from geopolitical tensions, raw material shortages, or regulatory delays can impact supply stability.
- Emerging Trends: Manufacturing capacity expansion, digital supply chain management, and sustainability initiatives are shaping future supplier dynamics.
FAQs
1. Who are the primary global suppliers of SARAFEM?
Major players include Eli Lilly (original patent holder), Teva, Mylan (Viatris), Torrent Pharmaceuticals, and Sun Pharmaceutical Industries, all of which produce generic fluoxetine formulations for international markets.
2. Are there regional differences in SARAFEM suppliers?
Yes. Indian and Chinese manufacturers dominate regional markets due to lower production costs and extensive manufacturing facilities, while Western markets tend to rely more on established multinational firms with stringent quality standards.
3. How does patent expiration impact SARAFEM supply?
Patent expiration has allowed multiple generics to enter the market, increasing the number of suppliers and enhancing supply stability, although it also intensifies competition and price pressures.
4. What factors should health organizations consider when selecting SARAFEM suppliers?
Regulatory compliance, manufacturing capacity, quality certifications, supply chain reliability, pricing, and geopolitical stability are key considerations.
5. What future developments could influence SARAFEM supplier landscape?
Expansion of manufacturing capacity in Asia, advancements in supply chain traceability, regulatory changes, and sustainability initiatives are expected to influence future supplier strategies.
Sources:
[1] FDA Drug Approvals and Market Data.
[2] Eli Lilly & Co. Corporate Reports.
[3] Teva Pharmaceutical Annual Reports.
[4] World Health Organization, Essential Medicines List.
[5] Industry Analysis Reports on Pharmaceutical Manufacturing.
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