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Suppliers and packagers for generic pharmaceutical drug: CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE
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CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| United Guardian | RENACIDIN | citric acid; gluconolactone; magnesium carbonate | SOLUTION;IRRIGATION | 019481 | NDA | United-Guardian, Inc. | 0327-0012-30 | 30 BOTTLE in 1 CARTON (0327-0012-30) / 30 mL in 1 BOTTLE | 2016-02-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ppliers for the Pharmaceutical Ingredients: Citric Acid, Gluconolactone, and Magnesium Carbonate
Introduction
The global pharmaceutical industry relies heavily on high-quality active ingredients and excipients to ensure product efficacy, safety, and compliance with regulations. Among these, citric acid, gluconolactone, and magnesium carbonate are commonly used in various formulations. Their suppliers are pivotal in maintaining supply chain integrity. This analysis identifies key suppliers for these ingredients, evaluates their market positioning, and explores implications for pharmaceutical manufacturers.
Citric Acid Suppliers
Overview
Citric acid (C6H8O7) is a weak organic acid extensively used as a buffering agent, preservative, and flavor enhancer in pharmaceuticals. The demand stems from its application in oral rehydration solutions, effervescent formulations, and stabilizers.
Major Suppliers
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Jungbunzlauer
- Overview: Swiss-based company, prominent global supplier of food and pharma-grade citric acid.
- Capabilities: Offers high-purity, food & pharmaceutical grade citric acid with certifications (FSSC 22000, EHEDG) suitable for injectable and oral formulations.
- Market Position: Recognized for consistent quality and sustainable production practices.
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Cargill (Tate & Lyle)
- Overview: A major global player with extensive manufacturing facilities.
- Capabilities: Provides pharmaceutical-grade citric acid conforming to USP, EP, and JP standards.
- Market Position: Competitive pricing and broad distribution network.
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Matsutani
- Overview: Japan-based manufacturer with a reputation for high-quality specialty acids.
- Capabilities: Supplies pharmaceutical-grade citric acid tailored for various formulations.
- Market Position: Niche focus with high-quality standards.
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FMC Corporation
- Overview: A diversified chemical company with production capacities for food and pharma ingredients.
- Capabilities: Offers USP and EP grade citric acid with a focus on food and pharmaceutical compliance.
Regional Suppliers
- Shandong Huatong Chemical Co., Ltd. (China) – Offers competitive pricing, primarily for regional markets.
- Tate & Lyle (UK/Global) – Long-standing supplier with global reach.
Gluconolactone Suppliers
Overview
Gluconolactone (D-glucono-δ-lactone, GDL) is used as an acidity regulator, cross-linking agent, and in controlled-release formulations. Its pharmaceutical application necessitates the highest purity standards (generally USP, EP).
Major Suppliers
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Harima Chemicals Group
- Overview: Japan-based, leading producer of GDL.
- Capabilities: Supplies pharmaceutical-grade gluconolactone with strict quality controls.
- Market Position: Known for advanced manufacturing and high purity standards.
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Yuki Gosei Kogyo Co., Ltd.
- Overview: Japanese company specializing in organic acids and related compounds.
- Capabilities: Provides pharmaceutical-grade GDL with comprehensive certifications.
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Musashino Chemical Laboratory
- Overview: Japanese firm with a focus on specialty chemicals for pharmaceutical applications.
- Capabilities: Supplies GMP-compliant gluconolactone for injectable and oral formulations.
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Shandong Freda Biotechnology Co., Ltd. (China)
- Overview: Growing presence in chemical manufacturing, including GDL.
- Capabilities: Offers competitively priced GDL meeting pharmaceutical standards.
Emerging and Regional Suppliers
- Sino-Xylitol Pharmaceutical (China) – Focused on regional markets with quality standards aligned to GMP.
Magnesium Carbonate Suppliers
Overview
Magnesium carbonate (MgCO3) serves as an antacid, excipient, and absorbent. Pharmaceutical-grade magnesium carbonate must conform to USP, EP, or JP standards, emphasizing purity and minimal contaminant levels.
Major Suppliers
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Süd-Chemie (Cabot Corporation)
- Overview: Transformed into Clariant, now part of SK Geotechnical.
- Capabilities: Supplies high-purity magnesium carbonate for pharmaceutical applications.
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VWR Chemicals (Avantor)
- Overview: Global distributor sourcing from multiple manufacturers.
- Capabilities: Offers pharmaceutical-grade magnesium carbonate with certification documentation.
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GCC Chemical Co., Ltd. (Japan)
- Overview: Specialty chemical manufacturer for pharmaceutical excipients.
- Capabilities: Provides GMP-grade magnesium carbonate.
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Fengrun High-Tech (China)
- Overview: Major producer supplying regional and global markets.
- Capabilities: Source of USP and EP grade magnesium carbonate at competitive prices.
Regional and Niche Suppliers
- Sri Ram Minerals (India) – Focuses on domestic markets meeting international standards.
Supply Chain Considerations
Quality Assurance & Certification
Suppliers must provide certificates of analysis conforming to pharmacopoeial standards (USP, EP, JP). Validated manufacturing processes ensure consistent supply and regulatory compliance.
Regulatory & Quality Certifications
- GMP certification
- ISO 9001/14001
- Specific pharmacopoeial certifications (USP, EP, JP)
Sustainability and Ethical Standards
Increasing demand for suppliers with sustainable sourcing practices aligns with regulatory trends and corporate responsibility initiatives.
Market Trends & Implications for Pharmaceutical Companies
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Consolidation and Reliability: Dominance of established players like Jungbunzlauer, Cargill, and Harima underscores the importance of supplier reliability in formulation stability and regulatory compliance.
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Regional Sourcing: Growing regional manufacturers in China and India offer cost advantages but require rigorous quality verification to meet international standards.
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Supply Chain Disruptions: The COVID-19 pandemic emphasized vulnerabilities; global suppliers with diversified manufacturing bases are favored to mitigate risks.
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Sustainability Concerns: Suppliers adopting environmentally friendly production processes and sustainable sourcing are becoming preferred partners.
Key Takeaways
- Global leaders dominate: Jungbunzlauer, Cargill, and Harima Chemicals are primary suppliers for citric acid, gluconolactone, and magnesium carbonate, respectively, providing high-quality, certified ingredients for pharmaceutical use.
- Quality certifications are non-negotiable: Ensuring products meet USP, EP, or JP standards is critical for regulatory approval and product safety.
- Regional suppliers are gaining prominence but necessitate rigorous quality assessments. Companies should balance cost with compliance.
- Supply chain resilience hinges on diversification and establishing relationships with multiple proven suppliers.
- Sustainability and transparency from suppliers influence procurement decisions, aligning with global regulatory and corporate sustainability goals.
Frequently Asked Questions
Q1: What are the key quality standards for pharmaceutical-grade citric acid, gluconolactone, and magnesium carbonate?
A1: They must meet pharmacopoeial standards—USP, EP, or JP—which specify purity levels, absence of contaminants, and excipient-specific criteria. Certificates of analysis and GMP compliance are essential.
Q2: How can pharmaceutical companies verify supplier certifications?
A2: Through detailed audits, review of certification documents, and third-party verification agencies. Maintaining approved supplier lists and regular audits ensures ongoing compliance.
Q3: Are there regional suppliers that offer comparable quality to global leaders?
A3: Yes. Chinese suppliers such as Shandong Freda Biotechnology and Fengrun High-Tech have advanced manufacturing processes and offer competitively priced ingredients meeting international standards but require due diligence.
Q4: What trends are influencing supplier selection in the pharmaceutical excipients market?
A4: Trends include increased emphasis on supply chain resilience, regulatory compliance, sustainability, and cost efficiency. Manufacturers increasingly prefer suppliers with proven track records and robust quality controls.
Q5: How does supply chain diversification mitigate risks associated with ingredient shortages?
A5: Diversifying suppliers across geographical regions and establishing relationships with multiple reputable providers reduce dependency on single sources, minimizing production disruptions due to geopolitical, logistical, or environmental issues.
References
- Jungbunzlauer. (2023). Pharmaceutical-grade citric acid. [Online] Available at: https://www.jungbunzlauer.com/ingredients/pharmaceuticals/
- Cargill. (2023). Food and pharma-grade citric acid products. [Online] Available at: https://www.cargill.com/food-bev/food-additives/citric-acid
- Harima Chemicals Group. (2023). GDL for pharmaceutical applications. [Online] Available at: https://www.harima.co.jp/english/chemical/
- VWR. (2023). Pharmaceutical excipients and chemicals. [Online] Available at: https://us.vwr.com/
- SPS Commerce. (2023). Global Supply Chain Trends for Pharmaceutical Ingredients.
Note: This article provides a snapshot based on current industry data. Suppliers’ offerings and market positions are subject to change with ongoing industry developments.
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