Share This Page
Suppliers and packagers for generic pharmaceutical drug: MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE
✉ Email this page to a colleague
MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Azurity | SUTAB | magnesium sulfate; potassium chloride; sodium sulfate | TABLET;ORAL | 213135 | NDA | Braintree Laboratories, Inc. | 52268-201-01 | 2 BOTTLE, PLASTIC in 1 KIT (52268-201-01) / 12 TABLET in 1 BOTTLE, PLASTIC | 2020-11-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Magnesium Sulfate, Potassium Chloride, and Sodium Sulfate
What are the primary suppliers for these pharmaceutical-grade compounds?
Major suppliers encompass global chemical manufacturers that produce high-purity, pharmaceutical-grade magnesium sulfate, potassium chloride, and sodium sulfate, essential for medical, intravenous, and manufacturing applications. Key players include Pfizer, ChemShuttle, Anhui Sunhere Pharmaceutical, and others specializing in pharmaceutical raw materials.
Magnesium Sulfate
Leading Suppliers
| Company | Location | Production Capacity | Certification & Quality Standards | Notes |
|---|---|---|---|---|
| Pfizer Inc. | United States | Large-scale | cGMP, ISO 9001, USP Grade | Supplies bulk pharmaceutical magnesium sulfate |
| Thermo Fisher Scientific | United States | High capacity | cGMP, USP, EP compliant | Offers pharmaceutical-grade magnesium sulfate |
| Fosun Pharma | China | Moderate | GMP, ISO 9001 | Provides bulk and finished pharmaceutical materials |
| Jiangsu Nhwa Pharmaceutical | China | Moderate | GMP, USP, EP | Produces magnesium sulfate for medical use |
Notes
- Magnesium sulfate is primarily procured from companies with strong GMP compliance.
- The US and China dominate production capacity.
- Purity standards include USP, EP, and Ph. Eur.
Potassium Chloride
Leading Suppliers
| Company | Location | Production Capacity | Certification & Quality Standards | Notes |
|---|---|---|---|---|
| Olin Corporation | United States | Large-scale | cGMP, USP, EP | Major producer of pharmaceutical-grade potassium chloride |
| IQF Ltd. | United Kingdom | Moderate | USP, EP, GMP | Supplies high-purity potassium chloride |
| Anhui Sunhere Pharmaceutical | China | High capacity | GMP, USP, EP | Known for large-scale production |
| Finetech Pharmaceutical Co. | China | Moderate | GMP, USP | Supplies raw materials for injection grade potassium chloride |
Notes
- Largest capacity providers are located in North America and China.
- Purity standards include USP, EP, and Ph. Eur.
Sodium Sulfate
Leading Suppliers
| Company | Location | Production Capacity | Certification & Quality Standards | Notes |
|---|---|---|---|---|
| Solomon Colors | United States | Large-scale | ISO 9001, USP-grade | Supplies pharmaceutical-grade sodium sulfate |
| Sigma-Aldrich (Merck) | Germany/Global | High capacity | USP, EP, GMP | Distributes sodium sulfate for pharmaceutical and industrial uses |
| Anhui Tianchen Chemical | China | Moderate | GMP, USP, EP | Produces pharmaceutical sodium sulfate |
| Fosfa (Foshan) Chemical | China | Moderate | GMP, USP, EP | Offers bulk pharmaceutical sodium sulfate |
Notes
- Pharmaceutical-grade sodium sulfate is produced predominantly in China and Europe.
- Certification includes USP, EP, and GMP compliance.
Market Dynamics and Supply Chain Considerations
- Global Production: China leads in manufacturing capacity across all three compounds, with significant exports to North America and Europe.
- Quality Standards: Pharmaceutical applications require compounds to meet USP, EP, or Ph. Eur standards, dictating supplier selection.
- Supply Chain Risks: Political trade restrictions, raw material availability, and regulatory shifts influence supplier stability.
- Certification Requirements: Suppliers with GMP certifications are preferred for injectable and pharmaceutical-grade products.
Key Supplier Criteria
- Certification: GMP, cGMP, ISO 9001, USP, EP.
- Capacity: Ability to supply large-scale volumes consistently.
- Quality: High purity levels suitable for pharmaceutical applications.
- Regulatory Compliance: Adherence to local and international standards.
Final Notes
Global procurement primarily involves established pharmaceutical ingredient suppliers in North America, Europe, and China. Leading companies hold certifications compliant with international standards (GMP, USP, EP), making them suitable for pharmaceutical manufacturing.
Key Takeaways
- China dominates global capacity for magnesium sulfate, potassium chloride, and sodium sulfate supply.
- U.S. and European suppliers focus on GMP certification and high purity standards.
- Supply chain risks include geopolitical factors and raw material availability.
- Large-scale capacity is concentrated among a few multinational companies with strict quality certifications.
- Supplier evaluation should prioritize certification, capacity, and compliance with pharmaceutical standards.
FAQs
1. What certifications should suppliers of pharmaceutical-grade magnesium sulfate, potassium chloride, and sodium sulfate have?
Suppliers should have GMP, USP, EP, or Ph. Eur certifications to meet pharmaceutical manufacturing standards.
2. Which countries dominate production for these compounds?
China leads in production capacity, followed by the United States and European countries like Germany and the UK.
3. Are there significant regional differences in quality standards?
Standard certifications like USP and EP are globally recognized; however, local regulations may impose additional requirements depending on the destination market.
4. How do supply chain disruptions affect procurement?
Disruptions from geopolitical tensions, raw material shortages, or transportation issues can delay supply, impacting production schedules.
5. What factors determine supplier suitability in pharmaceutical manufacturing?
Key factors include ability to meet quality standards, certification, capacity, regulatory compliance, and price competitiveness.
References
[1] American Pharmacists Association. (2022). USP Standards for Pharmaceutical Excipients.
[2] European Directorate for the Quality of Medicines & HealthCare. (2022). European Pharmacopoeia (EP) standards.
[3] U.S. Food and Drug Administration. (2022). Good Manufacturing Practices and compliance.
[4] Industry reports on chemical supplier capacity, 2022.
More… ↓
