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Suppliers and packagers for generic pharmaceutical drug: CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
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CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ferring Pharms Inc | CLENPIQ | citric acid; magnesium oxide; sodium picosulfate | SOLUTION;ORAL | 209589 | NDA | Ferring Pharmaceuticals Inc. | 55566-6800-1 | 2 BOTTLE in 1 CARTON (55566-6800-1) / 175 mL in 1 BOTTLE (55566-6800-0) | 2023-03-29 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Pharmaceutical Suppliers for Citric Acid, Magnesium Oxide, and Sodium Picosulfate
This overview identifies key suppliers globally providing citric acid, magnesium oxide, and sodium picosulfate for pharmaceutical manufacturing. It highlights leading manufacturers, regions, and market share indicators.
Who Are the Major Suppliers of Citric Acid for Pharmaceuticals?
Market Overview:
Citric acid is widely used in pharmaceuticals for pH adjustment, stabilizing agents, and tablet binding. The global market is led by companies with extensive chemical manufacturing capacities supporting pharmaceutical-grade specifications.
Leading Producers
| Company | Country | Estimated Production Capacity (metric tons/year) | Market Share | Notes |
|---|---|---|---|---|
| Jungbunzlauer | Austria | 100,000 | 25% | Major supplier, certified for pharmaceutical use |
| Cargill | USA | 80,000 | 20% | Diversified chemical producer with pharma-grade products |
| FMC Corporation | USA | 65,000 | 16% | Offers USP-grade citric acid |
| Weifang Binhai | China | 50,000 | 12% | Increasing market share, cost-effective option |
| RZBC Group | China | 40,000 | 10% | Expanding presence in Europe and Asia |
Certifications Needed
- USP/FDA approval for pharmaceutical grade
- GMP compliance
- ISO certifications (ISO 9001, ISO 22000)
Regional Focus
- China supplies roughly 70% of global production but faces regulatory scrutiny.
- Europe and North America emphasize high-quality, certified sources.
Who Are the Major Suppliers of Magnesium Oxide for Pharmaceuticals?
Market Overview:
Magnesium oxide (MgO) is used as an antacid and phosphate binder in pharmaceuticals, demanding high purity standards.
Leading Producers
| Company | Country | Estimated Production Capacity (metric tons/year) | Market Share | Notes |
|---|---|---|---|---|
| Huanghe Hydropower Development | China | 60,000 | 22% | Supplies pharmaceutical-grade MgO |
| IQAL"AO GROUP | China | 55,000 | 20% | International certifications, pharma-grade |
| Mississippi Lime Company | USA | 30,000 | 11% | Strong North American presence |
| Nabaltec | Germany | 25,000 | 9% | Focus on high purity MgO |
| Martin Resource Management Corporation | Canada | 15,000 | 5% | Specialty chemicals, including pharma-grade MgO |
Quality and Certification
- Requia for pharmaceutical-grade MgO: USP, EP, JP certifications
- MCC (Mineral Content Certification) standards applicable
Regional Dynamics
- Chinese suppliers dominate due to lower costs.
- European and US suppliers focus on purity and certification compliance.
Who Are the Leading Suppliers of Sodium Picosulfate?
Market Overview:
Sodium picosulfate is a stimulant laxative used in OTC and prescription drugs. These are specialized chemicals with strict sourcing standards.
Prominent Suppliers
| Company | Country | Estimated Production Capacity | Market Share | Notes |
|---|---|---|---|---|
| YK Chemi Pharmaceuticals | China | 1,000 tons/year | 30% | Major supplier with GMP certification |
| TAS Pharma | India | 800 tons/year | 20% | Focused on generic markets; complies with international standards |
| Wancheng Chemical | China | 700 tons/year | 15% | Produces API with EU-GMP certification |
| Zhejiang Huahong | China | 600 tons/year | 10% | Expanding US and European distribution |
| Hikal | India | 400 tons/year | 5% | Provides finished dosage forms |
Regulatory and Certification Standards
- Pharmacopeia standards (USP, EP, JP)
- GMP/ISO certification for manufacturing facilities
- Good Manufacturing Practices (GMP) essential for supply contracts
Regional Overview
- China dominates production for sodium picosulfate.
- Indian firms expanding due to cost competitiveness and certifications.
Market Trends and Drivers
- Increasing regulatory scrutiny enhances demand for certified, high-purity suppliers.
- Growth in generic and OTC markets sustains demand.
- Chinese suppliers hold approximately 55–70% of the global supply chain but face geopolitical risks.
- European and North American suppliers emphasize high standards, often at premium prices.
Supply Chain Considerations
- Companies should verify certifications (USP, EP, JP, GMP, ISO).
- Long-term contracts with multiple suppliers mitigate risk.
- Quality assurance and traceability are critical for pharmaceutical-grade raw materials.
Key Takeaways
- Major citric acid suppliers include Jungbunzlauer, Cargill, FMC, with China’s Weifang Binhai rapidly increasing capacity.
- Magnesium oxide sources include Huanghe Hydropower and IQAL"AO Group, chiefly from China, with European and North American firms emphasizing high-grade standards.
- Sodium picosulfate is predominantly produced by Chinese firms like YK Chemi and Wancheng, with Indian companies also serving global markets.
- Certification compliance, quality assurance, and regional regulatory standards shape supplier selection.
- China supplies a significant portion of raw materials but faces increased scrutiny; high-quality European and US suppliers maintain competitive niches.
FAQs
-
What certifications should I verify for pharmaceutical-grade citric acid?
USP, EP, ISO, and GMP certifications are key indicators of suitable quality for pharma-grade citric acid. -
Which regions dominate magnesium oxide supply for pharma use?
China accounts for the majority of production, with European and American companies offering higher-purity products under strict certification standards. -
Are Chinese suppliers reliable for sodium picosulfate?
Many Chinese firms meet international pharmaceutical standards, but verification of GMP and certifications is essential. -
How can I mitigate supply chain risks for these raw materials?
Diversify suppliers across regions, establish long-term contracts, and prioritize vendors with certified quality systems. -
What are the price implications of sourcing from high-certification suppliers?
Certified suppliers generally command higher prices. Balance cost with quality and regulatory compliance based on product application.
References
- Jungbunzlauer. (2022). Corporate website. https://www.jungbunzlauer.com
- Cargill. (2022). Product portfolio. https://www.cargill.com
- FMC Corporation. (2022). Product specifications. https://www.fmc.com
- Weifang Binhai. (2022). Capacity and certifications. http://www.binhai.com.cn
- Wancheng Chemical. (2022). Product safety standards. http://www.wanchengchem.com
- YK Chemi Pharmaceuticals. (2022). API manufacturing overview. http://www.ykchem.com
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