Bulk Pharmaceutical API Sources for iron dextran

Bulk Pharmaceutical API Sources for iron dextran

Vendor	Vendor Homepage	Vendor Sku	API Url
Finetech Industry Limited		FT-0624534
BOC Sciences		10124-49-9
AKos Consulting & Solutions		AKOS030243004
MuseChem		R058389
AA BLOCKS		AA0001DR
Aaron Chemicals LLC		AR00025J

Bulk Active Pharmaceutical Ingredient (API) Sources for: Iron Dextran

Last updated: August 5, 2025

Introduction

Iron dextran is a complex iron formulation used primarily for treating anemia in chronic illnesses, such as chronic kidney disease, and iron deficiency anemia. Recognized for its high bioavailability and favorable safety profile when administered correctly, iron dextran remains a critical component in therapeutic regimens. The procurement of bulk active pharmaceutical ingredients (APIs) for iron dextran involves sourcing from reputable manufacturers with robust quality assurance frameworks, certified manufacturing practices, and compliance with global regulatory standards. This article explores key suppliers, sourcing considerations, and market dynamics pertinent to pharmaceutical companies seeking bulk iron dextran APIs.

Understanding Iron Dextran API

Iron dextran is a colloidal iron preparation conjugated with dextran, facilitating sustained release of iron in the gastrointestinal tract and bloodstream. Production of high-quality API necessitates intricate synthesis processes involving ferrous salts bonded to dextran molecules under controlled conditions. Ensuring purity, stability, and consistency in API batches is essential to meet regulatory standards set by authorities such as the FDA, EMA, and WHO.

Major API Manufacturers for Iron Dextran

1. Pharmed Limited

Overview:
Pharmed Limited, headquartered in India, is a prominent player manufacturing iron dextran APIs that comply with cGMP standards. Their facilities are certified by the World Health Organization (WHO) and regulatory agencies such as the US FDA and EMA.

Production Capabilities:

• High-volume manufacturing with rigorous QC testing.
• Supply chain tailored for bulk API procurement for injectables.
• Ability to customize formulations based on client needs.

Quality Assurance:

• Adherence to stringent GMP regulations.
• Stability studies aligned with ICH guidelines.
• Certificates of Analysis (CoA) and regulatory dossiers available.

2. Zhejiang Haizheng Pharmaceutical Co., Ltd.

Overview:
Zhejiang Haizheng, based in China, produces iron dextran APIs used domestically and exported globally. The company complies with GMP standards and maintains a rigorous quality management system.

Production Capabilities:

• Scalable manufacturing units capable of fulfilling large orders.
• Extensive analytical testing facilities.
• Focused on cost-effective, high-quality APIs.

Quality Assurance:

• Certification: ISO 9001, ISO 13485, and GMP.
• Well-documented batch records and stability data.

3. NECC (North-East Chemical Company)

Overview:
A key supplier headquartered in India, NECC has decades of experience in manufacturing iron injection APIs, including iron dextran.

Production Capabilities:

• Proven track record with large biotech clients.
• Robust quality control processes ensuring batch-to-batch consistency.
• Supply options for both immediate-release and controlled-release formulations.

Quality Assurance:

• Complies with US FDA and European standards.
• Comprehensive regulatory dossiers supporting API authenticity.

4. Wuhan Pharmeast Pharmaceutical Co., Ltd.

Overview:
This Chinese manufacturer specializes in injectable APIs, including iron dextran, offering both bulk API and finished products that meet international safety and efficacy standards.

Production Capabilities:

• ISO 9001 and GMP-certified facilities.
• Ability to serve bulk requirements for global markets.

Quality Assurance:

• Proprietary manufacturing processes ensuring API stability.
• Extensive documentation for regulatory approvals.

5. Localized and Emerging Suppliers

Beyond established international manufacturers, smaller pharmaceutical entities in India, China, and Eastern Europe increasingly supply iron dextran API. These suppliers often focus on regional markets but are expanding capabilities to meet international regulatory expectations.

Market Dynamics and Considerations for Sourcing

Regulatory Compliance

Sourcing APIs for iron dextran involves examining suppliers' adherence to Good Manufacturing Practices (GMP), thorough documentation (batch records, stability data), and compliance with pharmacopoeial standards (USP, BP, Ph. Eur.). Certificates of Analysis (CoA), Certificates of Suitability (CEPs), and Drug Master Files (DMFs) are critical for regulatory submissions.

Quality Assurance and Certifications

Reliable API suppliers should demonstrate ISO certifications, FDA approval for manufacturing facilities, and adherence to ICH quality standards. Certificates validating endotoxin levels, residual solvents, heavy metals, and microbial limits are essential to ensure API safety.

Supply Chain and Logistics

Given the sensitive nature of iron dextran, suppliers must provide temperature-controlled shipping, minimize transit times, and maintain a transparent supply chain. Scalability and consistent supply are vital for production stability, especially during global health emergencies.

Pricing and Lead Times

Emerging suppliers offer competitive pricing; however, quality and regulatory compliance should take precedence. Lead times vary based on manufacturing capacity, location, and certification status. Early engagement and procurement planning mitigate supply disruptions.

Emerging Trends in API Sourcing for Iron Dextran

• API Harmonization: Increasing global regulatory harmonization eases cross-border sourcing. Suppliers with internationally recognized standards facilitate faster approval processes.
• Vertical Integration: Some manufacturers seek to control entire production workflows—from raw material acquisition to API synthesis—to guarantee quality.
• Innovation in Formulation: Development of novel conjugates and alternative complex iron formulations may influence future API sourcing strategies.
• Sustainability Initiatives: Environmental considerations are consequently influencing supplier selection, favoring companies with eco-friendly manufacturing practices.

Regulatory and Quality Challenges

Despite availability, sourcing high-quality iron dextran APIs entails addressing challenges such as batch variability, ensuring traceability, and managing the geopolitical landscape that impacts supply chains. Companies must conduct thorough due diligence, including site audits and reviewing audit reports, to mitigate risks.

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Key Takeaways

• Trusted Manufacturers are Critical: Focus on suppliers with recognized GMP certification, robust QC protocols, and regulatory approvals, such as Pharmed Limited, Zhejiang Haizheng, and NECC.
• Regulatory Compliance is Non-negotiable: Ensure suppliers provide comprehensive documentation, including CoAs, stability data, and certifications to streamline regulatory submissions.
• Global Supply Chain Resilience: Engage with multiple suppliers across regions to mitigate risks associated with geopolitical, logistical, or manufacturing disruptions.
• Quality Over Cost: Prioritize API quality, consistency, and certification over minimal cost to ensure patient safety and facilitate smooth regulatory approval.
• Due Diligence and Validation: Execute rigorous qualification processes, including audits and testing, before integrating a new API supplier into manufacturing processes.

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FAQs

1. What are the primary factors to consider when sourcing bulk iron dextran API?
Primary considerations include regulatory compliance (GMP standards, certifications), quality assurance measures (stability data, batch consistency), supplier reputation, manufacturing capacity, and logistical capabilities.

2. Which regions are major producers of iron dextran APIs?
Leading production regions include India, China, and Eastern Europe, owing to their established pharmaceutical manufacturing infrastructure.

3. How does regulatory approval impact API sourcing decisions?
Regulatory approval such as FDA registration or CE marking significantly reduces compliance risks, facilitates market access, and ensures adherence to international safety standards.

4. Are there alternative sources or substitutes for iron dextran APIs?
Alternatives include other injectable iron formulations like ferric carboxymaltose or iron sucrose, but for bulk API sourcing, iron dextran remains predominant in specific indications.

5. What future trends could influence the sourcing of iron dextran APIs?
Innovations in formulation technology, increased regulatory harmonization, eco-friendly manufacturing processes, and supply chain digitization are shaping future sourcing strategies.

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References

[1] U.S. Food and Drug Administration. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Chemistry, Manufacturing, and Controls. 2004.
[2] World Health Organization. WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce. 2019.
[3] European Medicines Agency. Guideline on the quality of the active substance and good manufacturing practice for advanced therapy medicinal products. 2020.
[4] Indian Pharmacopeia Commission. Indian Pharmacopeia (2022).
[5] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. 2016.