CITRIC ACID; UREA C-13: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Meridian Bioscience	IDKIT:HP	citric acid; urea c-13	FOR SOLUTION, TABLET, FOR SOLUTION;ORAL	021314	NDA	Meridian Bioscience Israel Ltd	50402-100-13	25 BAG in 1 BOX (50402-100-13) / 1 SOLUTION in 1 BAG	2009-12-28
Meridian Bioscience	IDKIT:HP	citric acid; urea c-13	FOR SOLUTION, TABLET, FOR SOLUTION;ORAL	021314	NDA	Meridian Bioscience Israel Ltd	50402-100-14	5 BOX in 1 CASE (50402-100-14) / 1 SOLUTION in 1 BOX	2009-12-28
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 4, 2025

Introduction

The pharmaceutical industry relies heavily on high-purity raw materials for manufacturing various formulations. Among these, citric acid and urea C-13 (a stable isotope-labeled compound) are critical for applications ranging from dietary supplements to radiolabeling in pharmacokinetics and drug development. Securing reliable suppliers for these compounds ensures quality, consistency, and compliance with regulatory standards. This report provides a comprehensive overview of global suppliers providing citric acid and urea C-13, emphasizing their capabilities, regulatory adherence, and market positioning to assist industry stakeholders in procurement decisions.

Citric Acid Suppliers in the Pharmaceutical Sector

Overview of Citric Acid in Pharma

Citric acid (C₆H₈O₇) is a weak organic acid widely used as a pH regulator, preservative, and flavoring agent in pharmaceuticals. Pharmaceutical-grade citric acid must meet stringent purity standards, such as USP, EP, or JP specifications, ensuring safety and compatibility.

Leading Suppliers

BASF SE
- Global Presence: Headquartered in Germany, BASF supplies pharmaceutical-grade citric acid via its subsidiary BASF Food & Nutrition division.
- Capabilities: Offers high-purity anhydrous and monohydrate forms, validated production processes, and strict compliance with international standards (USP, EP).
- Regulatory Compliance: Meets pharmacopeial and GMP requirements, with extensive documentation.
Cargill Inc.
- Market Position: U.S.-based agribusiness firm with a strong presence in food and pharmaceutical ingredients.
- Product Offerings: Certified pharmaceutical citric acid in granular, anhydrous, and monohydrate forms.
- Quality Standards: Implements ISO and GMP standards, with extensive batch traceability and validation processes.
Jiangsu Titan Genomu Bio-Tech Co., Ltd.
- Region: China-based manufacturer specializing in organic acids for pharmaceutical use.
- Certifications: GMP, ISO 9001, and pharmacopeial standards aligned with USP and EP.
- Market Focus: Supplying both bulk and specialty grades for global pharma manufacturers.
Weifang Binhai Kangsen Co., Ltd.
- Key Attributes: Significant producer of food- and pharma-grade citric acid in Asia-Pacific, with certification systems ensuring compliance with international standards.
Mitsubishi Chemical Corporation
- Reputation: Japanese firm with a comprehensive portfolio of pharmaceutical excipients, including high-purity citric acid, supported by rigorous quality controls.

Market Considerations

Pricing Dynamics: Driven by raw material costs, regional regulations, and demand-supply balances.
Regulatory Navigation: Suppliers with certifications for GMP, FDA approval, and analytical validation reduce procurement risk.
Supply Chain Stability: Reliance on diversified manufacturing facilities and regional distribution centers ensures consistent delivery.

Urea C-13 Suppliers in the Pharmaceutical and Radiopharmaceutical Sector

Role of Urea C-13 in Pharma

Urea C-13, a stable isotope-labeled compound, serves primarily as a tracer in metabolic studies, pharmacokinetic research, and diagnostic imaging. Its purity, isotopic enrichment, and compliance with pharmaceutical standards are paramount.

Key Suppliers and Manufacturers

Cambridge Isotope Laboratories (CIL)
- Leading Provider: A U.S.-based global supplier specializing in stable isotope-labeled compounds, including Urea C-13.
- Product Profile: Urea C-13 with isotopic enrichment levels exceeding 99%, packaged for research and clinical applications.
- Quality Standards: Complies with USP, EP, and FDA requirements; offers extensive documentation and analytical validation.
ISOFLEX Isotopes GmbH
- European Market: German-based manufacturer providing high-purity Urea-13C, with custom isotopic enrichment levels.
- Application Focus: Supports pharmacokinetics, metabolic studies, and radiolabeling processes.
- Certifications: ISO 9001, GMP, and pharma-grade compliance.
Cambridge Isotope Laboratories’s Competitors
- Sigma-Aldrich (Part of MilliporeSigma): Offers certified, high-purity Urea C-13, primarily for research purposes, with fast delivery within North America and Europe.
Cambridge Isotope's Proprietary Production Facilities
- Manufacturing: Uses sophisticated isotope separation technologies ensuring batch-to-batch consistency and high isotopic purity.
- Supply Chain: Maintains robust logistics channels, ensuring supply security for commercial and clinical R&D.

Emerging and Regional Suppliers

Certain Chinese firms are increasing capacity for stable isotope production, but their compliance with international pharmacopeial standards varies, making due diligence essential.

Regulatory & Quality Compliance

Suppliers for pharmaceutical ingredients like citric acid and Urea C-13 must adhere to stringent quality and regulatory standards:

GMP Compliance: Ensures manufacturing processes meet international quality management standards, reducing contamination risks.
Pharmacopoeial Standards: USP, EP, or JP standards specify impurity thresholds, residual solvents, and analytical methods—important for sourcing.
Certifications: ISO 9001, ISO 13485, and others validate quality management systems.
Regulatory Approvals: For Urea C-13, suppliers often hold FDA approval or equivalent in target markets, facilitating import and use.

Market Trends & Procurement Strategies

Growing Demand: Increased use of isotopic tracers in personalized medicine and biomarker discovery expands Urea C-13 and citric acid markets.
Supply Chain Resilience: Diversifying supplier portfolios across regions minimizes risks associated with geopolitical or natural disruptions.
Quality Assurance: Prioritizing suppliers with comprehensive documentation, validation, and certification reduces regulatory retrieval issues.
Cost Optimization: Negotiating bulk supply agreements and establishing long-term partnerships can secure competitive pricing.

Key Takeaways

Global Providers: Major suppliers of pharmaceutical-grade citric acid include BASF, Cargill, Jiangsu Titan, Mitsubishi Chemical, and regional manufacturers with GMP certifications.
Specialized Niche: Urea C-13 suppliers like Cambridge Isotope Laboratories and ISOFLEX are authoritative sources, offering high-purity isotopic compounds essential for clinical research.
Regulatory Adherence: Ensuring supplier compliance with GMP and pharmacopeial standards minimizes quality and regulatory risks.
Supply Chain Management: Strategic sourcing from diversified, certified suppliers ensures steady supply, quality, and cost-effectiveness.
Market Evolution: Innovation in stable isotope manufacturing and increasing application breadth warrants ongoing supplier evaluation and relationship management.

FAQs

1. What are the critical factors to consider when sourcing citric acid for pharmaceuticals?
Supply chain stability, purity standards (USP/EP compliance), GMP certification, reliable documentation, and regional regulatory acceptability.

2. How does the isotopic enrichment level of Urea C-13 impact its application in research?
Higher isotopic enrichment (>99%) ensures precise tracing, imaging accuracy, and reproducibility, which are critical in pharmacokinetic and metabolic studies.

3. Are regional suppliers of citric acid sufficient for global pharmaceutical needs?
Yes, reputable regional suppliers with international certifications can meet global standards. However, establishing relationships with multiple providers ensures supply resilience.

4. What regulatory hurdles exist for importing stabilized isotopes like Urea C-13?
Compliance with local import regulations, validation of supplier certifications, and adherence to pharmacopeial standards are primary considerations.

5. How can a pharma company verify supplier compliance with quality standards?
Through certification audits, review of batch documentation, analytical validation reports, and supplier audits aligned with GMP and ISO standards.

Conclusion

Securing robust, compliant suppliers for citric acid and Urea C-13 is vital for pharmaceutical manufacturers engaged in formulation development, clinical trials, and diagnostic applications. Leading global producers offer high-quality, certified products with proven regulatory adherence, supporting the industry's stringent standards. Continuous monitoring of supplier performance, regulatory compliance, and market dynamics is essential to sustain supply chains, optimize costs, and maintain product integrity.

References

[1] BASF SE. "Pharmaceutical Ingredients." Available at: https://www.basf.com
[2] Cargill. "Food & Pharmaceutical Grade Citric Acid." Available at: https://www.cargill.com
[3] Cambridge Isotope Laboratories. "Stable Isotope Products." Available at: https://www.isotope.com
[4] ISOFLEX Isotopes GmbH. "High-Purity Isotopes for Research and Medicine." Available at: https://www.isoflex.de
[5] U.S. Pharmacopeia. "USP General Chapters and Monographs." Available at: https://www.usp.org

Suppliers and packagers for generic pharmaceutical drug: CITRIC ACID; UREA C-13