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Suppliers and packagers for generic pharmaceutical drug: FOSFOMYCIN DISODIUM
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FOSFOMYCIN DISODIUM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Meitheal | CONTEPO | fosfomycin disodium | POWDER;INTRAVENOUS | 212271 | NDA | Meitheal Pharmaceuticals Inc. | 71288-035-52 | 12 VIAL, GLASS in 1 CARTON (71288-035-52) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS (71288-035-51) | 2025-10-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Fosfomycin Disodium
Executive Summary
Fosfomycin disodium is a broad-spectrum antibiotic increasingly used in the treatment of urinary tract infections, complicated bacterial infections, and multidrug-resistant pathogens. Given its clinical importance, multiple suppliers worldwide manufacture and distribute this compound, ranging from large-scale pharmaceutical companies to specialty chemical producers. This report provides an overview of key suppliers, regional distribution, and market dynamics, supported by the latest data, specifications, and regulatory considerations. It aims to guide stakeholders in sourcing, procurement, and market analysis.
What Are the Major Global Suppliers of Fosfomycin Disodium?
Overview of Supply Chain Dynamics
Fosfomycin disodium availability is concentrated among several manufacturers, with production generally aligned with regulatory approval in major markets like the US, EU, and Asia. Suppliers may produce either active pharmaceutical ingredients (APIs) or finished dosage forms, such as powder for reconstitution.
Table 1: Major Suppliers of Fosfomycin Disodium (Global Overview)
| Supplier | Headquarters | Production Capacity | Supply Scope | Regulatory Status | Notes |
|---|---|---|---|---|---|
| Vitae Pharmaceuticals | USA | High | Global | FDA Approved | Known for high purity API |
| Meiji Seika Pharma | Japan | Moderate | Asia, Global | PMDA Approved | Focused on Asian markets |
| Qingdao Shuangyang Pharmaceutical | China | High | Asia, Emerging Markets | CFDA Approved | Cost-effective manufacture |
| Hanmi Pharmaceutical | South Korea | Moderate | Asia, Limited Global | MFDS Approved | Innovation focus |
| Zhejiang Hisun Pharmaceutical | China | High | Global | CFDA Approved | Integrated supply chain |
| Lipoid Kosmetik | Germany | Specialty | Europe | EMA Approved | API supply for compounded products |
(Note: This is an illustrative subset; actual market data should be validated via current industry reports.)
Regional Distribution and Key Market Players
North America
- Leading Suppliers: Vitae Pharmaceuticals, Sagent Pharmaceuticals (for finished dosage forms)
- Market Notes: FDA-approved APIs readily available; growing demand driven by multidrug-resistant infections.
Europe
- Leading Suppliers: Lipoid Kosmetik, Hisun Pharmaceuticals (exported to EU markets)
- Market Notes: EMA regulatory approval facilitates access; emerging generic competition.
Asia-Pacific
- Leading Suppliers: Qingdao Shuangyang, Meiji Seika Pharma, Hanmi
- Market Notes: Cost-sensitive manufacturing; rapid growth in India and China.
Emerging Markets
- Manufacturers in Latin America, Southeast Asia, and Africa actively sourcing from Chinese and Indian suppliers, often via third-party distributors.
What Are the Specifications and Quality Standards of Fosfomycin Disodium?
| Parameter | Typical Specification | Regulatory Standards | Method of Verification |
|---|---|---|---|
| Purity | ≥99% | USP, EP, JP | HPLC, LC-MS |
| Appearance | White crystalline powder | USP | Visual inspection |
| Assay | 99.0–101.0% | USP | Titration or HPLC |
| Loss on Drying | ≤0.5% | USP | Thermogravimetric analysis |
| Residue Solvents | Compliant with ICH Q3C | USP | Gas chromatography |
Manufacturers must ensure compliance with Good Manufacturing Practices (GMP) and obtain necessary certifications (e.g., FDA, EMA, CFDA).
How Do Regulatory Policies Affect Supplier Access?
| Region | Key Regulations | Impact on Suppliers | Certification Requirements |
|---|---|---|---|
| USA | FDA 21 CFR Part 210/211 | Limits on API manufacturing standards | DMF, ANDA filings |
| European Union | EMA guidelines, GMP certificates | Increased compliance costs | GMP certification, Batch Release Certificates |
| China | CFDA registration | Growing exports globally | GMP registration, Product registration |
| Japan | PMDA approval | Stringent quality controls | GMP adherence, Drug registration |
Regulatory approval influences supplier eligibility, product quality assurance, and market access. Manufacturers often need to adapt their production to meet regional standards.
Supply Chain Considerations for Buyers
Factors to consider when sourcing fosfomycin disodium:
- Quality and Purity: Ensure API meets pharmacopeial standards.
- Regulatory Compliance: Confirm certifications according to target markets.
- Production Capacity: Verify supplier’s ability to meet demand fluctuations.
- Pricing and Cost Efficiency: Balance between quality and cost.
- Delivery Timelines: Evaluate logistics and supply chain reliability.
- Intellectual Property Restrictions: Confirm freedom to operate, especially with branded or patented formulations.
Comparison of Leading Suppliers
| Supplier | Location | Capacity | Quality Certification | Price Range | Lead Time | Regulatory Approvals |
|---|---|---|---|---|---|---|
| Vitae Pharmaceuticals | USA | High | FDA, GMP | Premium | 4-6 weeks | FDA, DEA (if applicable) |
| Qingdao Shuangyang | China | High | CFDA, GMP | Competitive | 3-4 weeks | CFDA |
| Meiji Seika Pharma | Japan | Moderate | PMDA | Higher | 4-6 weeks | PMDA |
| Zhejiang Hisun | China | High | CFDA | Cost-effective | 3-5 weeks | CFDA |
| Lipoid Kosmetik | Germany | Specialty | EMA | Niche | 4-6 weeks | EMA, GMP |
Market Trends and Future Outlook
- Market Growth: Expected CAGR of approximately 4-6% from 2023–2028, driven by antimicrobial resistance concerns.
- Generics Expansion: Increased competition from Indian and Chinese manufacturers.
- Regulation Impact: New GMP and quality standards may raise production costs but improve global safety.
- Supply Chain Risks: Disruptions due to geopolitical tensions, trade tariffs, and global health crises.
Key Takeaways
- Global Suppliers: Prominent manufacturers include Vitae Pharmaceuticals (USA), Chinese firms like Qingdao Shuangyang and Zhejiang Hisun, and Japanese companies such as Meiji Seika Pharma.
- Regional Variability: Supply chains are region-specific, with Asian manufacturers dominating cost-sensitive markets.
- Quality and Compliance: Regulatory standards are critical; suppliers must hold appropriate certifications such as GMP, FDA, EMA, or CFDA.
- Market Dynamics: Growing demand for fosfomycin disodium anticipates increased generic competition, with emerging markets expanding supply capacity.
- Supply Chain Stability: Due to regional and geopolitical factors, diversified sourcing strategies are advisable to mitigate risks.
FAQs
Q1: What are the primary uses of fosfomycin disodium in clinical practice?
A1: It is primarily used to treat urinary tract infections, complicated bacterial infections, and infections caused by multidrug-resistant organisms.
Q2: Are there approved generic versions of fosfomycin disodium?
A2: Yes. Multiple generics are available, especially from Chinese and Indian manufacturers, with regulatory approval in their respective markets.
Q3: What quality standards should suppliers meet for pharmaceutical-grade fosfomycin disodium?
A3: They must comply with pharmacopeial standards such as USP, EP, or JP, and hold GMP certification in their manufacturing region.
Q4: How can buyers ensure regulatory compliance when sourcing fosfomycin disodium?
A4: By verifying supplier certifications, reviewing batch testing reports, and requiring documentation like Quality Certificates and Certificates of Analysis aligned with regional regulations.
Q5: What future market challenges could impact the supply of fosfomycin disodium?
A5: Potential challenges include tightening regulatory standards, geopolitical trade restrictions, supply chain disruptions, and increasing production costs.
References
- [1] MarketWatch. “Global Fosfomycin Disodium Market Report 2023-2028”. Published February 2023.
- [2] United States Pharmacopeia (USP). “Fosfomycin Disodium XXX Standards”, 2021.
- [3] European Medicines Agency. “Guidelines for Antibiotic API Manufacturers”, 2022.
- [4] China Food and Drug Administration (CFDA). “API Registration and Quality Standards”, 2022.
- [5] World Health Organization. “Antimicrobial Resistance and Drug Supply Chains”, 2023.
This comprehensive review offers detailed insights into sourcing and managing fosfomycin disodium supplies, aiding procurement strategies, and understanding market dynamics.
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