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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 |
ppliers for the Pharmaceutical Drugs: Citric Acid, Magnesium Oxide, and Sodium Picosulfate
Introduction
The pharmaceutical industry relies heavily on high-quality raw materials to formulate safe, effective medications. Citric Acid, Magnesium Oxide, and Sodium Picosulfate are widely used active and excipient ingredients, each serving distinct roles within pharmaceutical formulations. Ensuring a reliable supply chain for these substances is critical for manufacturers to meet regulatory standards, maintain production continuity, and deliver therapeutic solutions to patients. This article provides an in-depth overview of leading suppliers globally recognized for their quality, compliance, and capacity to supply these compounds sustainably.
Citric Acid: Overview and Leading Suppliers
Role and Significance
Citric Acid, a natural organic acid, is used extensively in pharmaceuticals as an excipient, pH buffer, preservative, and flavoring agent. Pharmaceutical-grade citric acid must meet stringent purity specifications, including high anhydrous or monohydrate standards, consistency, and compliance with pharmacopeial requirements.
Key Suppliers
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Jungbunzlauer
Recognized as a global leader in biodegradable ingredients, Jungbunzlauer supplies high-purity pharmaceutical-grade citric acid. Their products adhere to USP and EP standards and are renowned for quality control and sustainable manufacturing processes.
Headquarters: Switzerland; global reach with manufacturing sites in Europe and Asia. -
Cargill
Cargill offers pharmaceutical-grade citric acid with a focus on safety, traceability, and regulatory compliance. Their extensive distribution network ensures global availability.
Headquarters: USA; manufacturing facilities worldwide. -
Weifang Ensign Industry
A leading Chinese producer, offering high-quality citric acid with competitive pricing and compliance with international pharmacopeias. Their certifications include ISO and GMP. -
HULIC Laxmi Chemicals
Based in India, this company supplies pharmaceutical-grade citric acid to domestic and international markets, emphasizing quality assurance and regulatory adherence.
Magnesium Oxide: Overview and Leading Suppliers
Role and Significance
Magnesium Oxide (MgO) is employed in pharmaceuticals primarily as an antacid, laxative, and magnesium supplement. For pharmaceutical applications, high-purity, food, or pharmaceutical-grade MgO must meet specifications set by USP, EP, or other relevant pharmacopeias, with low levels of impurities such as heavy metals.
Key Suppliers
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Mississippi Lime Company
A U.S.-based producer specializing in high-purity MgO for medicinal and pharmaceutical uses, offering products that meet USP and EP standards. Their facilities emphasize quality control, consistency, and regulatory compliance. -
Magnesia Recycling Company
Located in China, this supplier produces pharmaceutical-grade MgO with ISO certifications, serving international markets. Their MgO undergoes rigorous testing to ensure purity suitable for medicinal use. -
Martin Marietta Materials
Engaged in producing specialty magnesium compounds, including food and pharmaceutical-grade MgO, with stringent quality management systems. -
Tai’an Sheng Hua Magnesium Co., Ltd.
A Chinese manufacturer providing high-purity MgO with certifications aligning with pharmaceutical standards, focusing on supply stability and quality.
Sodium Picosulfate: Overview and Leading Suppliers
Role and Significance
Sodium Picosulfate functions primarily as a stimulant laxative used in bowel preparation. As an API (Active Pharmaceutical Ingredient), it requires high purity, stability, and compliance with pharmacopeial specifications to ensure safety and efficacy.
Key Suppliers
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Sun Pharmaceutical Industries
One of the largest generic drug manufacturers globally, Sun Pharma produces high-quality Sodium Picosulfate APIs documented to meet USP and other relevant pharmacopeial standards. -
Eastman Chemical Company
A significant supplier of pharmaceutical intermediates and APIs worldwide, Eastman supplies Sodium Picosulfate for use in laxative formulations, ensuring product purity and regulatory compliance. -
Jubilant Cadista Pharmaceuticals
Specializing in the manufacture of pharmaceutical grade APIs, including Sodium Picosulfate, with a focus on quality assurance and regulatory adherence aligned with international standards. -
Missions Pharmatech
A regional supplier based in India, offering Sodium Picosulfate with certifications covering pharmacopeial specifications, suitable for global distribution.
Regulatory Standards and Quality Considerations
Suppliers for pharmaceutical-grade Citric Acid, Magnesium Oxide, and Sodium Picosulfate must comply with stringent regulatory standards such as USP, EP, JP (Japanese Pharmacopoeia), and ISO certifications. Quality control processes—including raw material sourcing, testing, and documentation—are vital for ensuring product consistency, safety, and legal compliance.
Supply Chain Reliability and Sourcing Strategies
- Diverse Supplier Portfolios: Industry leaders diversify sourcing to mitigate supply chain risks.
- Geographical Distribution: Suppliers across North America, Europe, and Asia enhance resilience and provide logistical flexibility.
- Long-term Partnerships: Establishing relationships with reputable suppliers ensures priority access, regulatory support, and quality assurance.
- Regulatory Vigilance: Continuous monitoring of supplier compliance with evolving standards (e.g., GMP, ICH guidelines) is crucial.
Conclusion
Securing reliable suppliers for Citric Acid, Magnesium Oxide, and Sodium Picosulfate is essential for pharmaceutical manufacturers aiming to ensure product quality and supply continuity. Leading global suppliers like Jungbunzlauer, Cargill, Mississippi Lime, and Sun Pharmaceutical provide high-quality, compliant products supported by robust quality systems. Strategic sourcing, regulatory alignment, and proactive supplier management underpin the resilience of pharmaceutical supply chains for these critical ingredients.
Key Takeaways
- Global suppliers for pharmaceutical-grade Citric Acid, including Jungbunzlauer and Cargill, emphasize purity, compliance, and sustainability.
- High-purity Magnesium Oxide suppliers, such as Mississippi Lime, serve the pharmaceutical industry with products meeting USP and EP standards.
- Leading Sodium Picosulfate providers like Sun Pharma and Eastman focus on meeting international pharmacopeial requirements for safety and efficacy.
- Regulatory compliance is non-negotiable; suppliers must adhere to strict standards like GMP, USP, and EP to ensure product acceptability worldwide.
- Supply chain diversification and continuous quality assurance are vital to maintaining uninterrupted production and regulatory compliance.
FAQs
1. How do I verify the quality compliance of suppliers for these ingredients?
Verify certifications such as GMP, USP, EP, ISO, and inspect test reports, certificates of analysis (CoA), and audit reports. Establish direct communication with suppliers for detailed documentation and conduct on-site audits if necessary.
2. What are the key considerations when sourcing Magnesium Oxide for pharmaceutical use?
Ensure high purity levels with low heavy metal content, confirm compliance with pharmacopeial standards (USP, EP), and verify supply chain stability to avoid shortages.
3. Are Chinese suppliers for Citric Acid and Magnesium Oxide reliable?
Many Chinese suppliers have achieved international certifications such as ISO and GMP, demonstrating compliance and quality. Due diligence and third-party audits improve confidence in their reliability.
4. How does supply chain disruption impact pharmaceutical ingredients?
Disruptions can delay production, increase costs, and pose regulatory risks. Diversification of suppliers and maintaining strategic inventory mitigate these risks.
5. What trends are shaping the procurement of these pharmaceuticals ingredients?
Growing emphasis on sustainability, stricter regulatory standards, and supply chain globalization influence sourcing strategies — pushing towards verified, compliant, and diversified supplier networks.
Sources
[1] Jungbunzlauer Official Website. "Citric Acid."
[2] Cargill Food & Pharma Ingredients. "Pharmaceutical-Grade Citric Acid."
[3] Mississippi Lime Company. "High Purity Magnesium Oxide."
[4] Eastman Chemical. "Pharmaceutical Intermediates."
[5] Sun Pharmaceutical Industries Ltd. Official Site. "Sodium Picosulfate API."
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