Bulk Pharmaceutical API Sources for dalteparin sodium

Bulk Pharmaceutical API Sources for dalteparin sodium

Vendor	Vendor Homepage	Vendor Sku	API Url
AbMole Bioscience		M5688

Bulk Active Pharmaceutical Ingredient (API) Sources for: Dalteparin Sodium

Last updated: August 4, 2025

Introduction

Dalteparin sodium, a low molecular weight heparin (LMWH), is a widely utilized anticoagulant primarily for the prevention and treatment of thromboembolic events. Its efficacy hinges on the purity, consistency, and supply stability of its active pharmaceutical ingredient (API). As demand for dalteparin sodium increases globally, particularly in treating deep vein thrombosis (DVT) and pulmonary embolism (PE), reliable supply chains from reputable API manufacturers become critical for pharmaceutical developers and healthcare providers.

This article explores the leading suppliers of bulk dalteparin sodium API, examining their manufacturing capabilities, regulatory compliance, and market positioning to assist industry stakeholders in sourcing high-quality products.

---

Market Overview and API Demand Dynamics

The global anticoagulant market has experienced a substantial uptick driven by the rising incidence of thrombotic disorders, aging populations, and expanding indications for LMWHs. Dalteparin sodium, under brands such as Fragmin (Pfizer), commands significant market share, necessitating a robust and compliant API supply chain.

The API's manufacturing complexity, involving sourcing of heparin raw material, fractional processing, depolymerization, and rigorous purification, constrains the number of API producers capable of producing pharmaceutical-grade dalteparin sodium at scale. Consequently, few manufacturers dominate in this niche.

---

Key API Suppliers for Dalteparin Sodium

1. Changshan Biochemical Pharmaceutical Co., Ltd. (China)

Overview
Changshan Biochemical is a leading Chinese manufacturer specializing in heparin-based APIs, including dalteparin sodium. The company has invested heavily in GMP-compliant manufacturing facilities and advanced depolymerization technology.

Capabilities & Regulatory Compliance

• GMP-certified plant compliant with Chinese and international standards.
• Proven track record supplying to global markets, including the US, Europe, and Asia.
• Strict quality control measures, including rigorous in-process testing and end-product assays aligned with pharmacopeias.

Market Position
Changshan's competitive pricing and large-scale production capacity make it a significant supplier for generic dalteparin sodium. Their extensive export network ensures active presence in various regions.

2. Changzhou Siyao Biotech Co., Ltd. (China)

Overview
Siyao Biotech is emerging as an important API supplier, targeting high purity heparin derivatives and related LMWHs, including dalteparin sodium.

Capabilities & Regulatory Compliance

• Approved by China Food and Drug Administration (CFDA).
• Focuses on regulatory compliance with international standards like EU GMP and US FDA.
• Emphasizes quality assurance through advanced analytics, including NMR and HPLC.

Market Position
Despite its relative newness, Siyao is expanding its global footprint, appealing to customers seeking reliable, high-quality API sources.

3. Sichuan Yuanda Shuyang Pharmaceutical Co., Ltd. (China)

Overview
Yuanda Shuyang specializes in biologics and heparin derivatives, with a rapidly growing portfolio of pharmaceutical APIs.

Capabilities & Regulatory Compliance

• GMP-certified facilities conforming to international standards.
• Adequate capacity for large-scale production of dalteparin sodium API, suitable for global supply.

Market Position
Its focus on process innovation and quality control positions it as a dependable supplier for pharmaceutical manufacturers.

4. Scientific Protein Laboratories LLC (SPL) (USA/Europe)

Overview
SPL is renowned globally for its heparin and LMWH APIs, leveraging proprietary manufacturing processes and extensive regulatory experience.

Capabilities & Regulatory Compliance

• Facilities compliant with cGMP standards recognized by the FDA and EMA.
• Supplies pharmaceutical-grade dalteparin sodium API globally.
• Focused on product consistency, traceability, and rigorous testing, including bioassays and chromatographic analysis.

Market Position
SPL’s established reputation in the heparin market ensures a reliable supply and extensive regulatory support, making it a preferred partner for multinational pharmaceutical companies.

5. Techdow (formerly Jiangsu Hengrui Medicine) (China)

Overview
Techdow has expanded into LMWH manufacturing, offering bulk dalteparin sodium API backed by robust R&D and manufacturing infrastructure.

Capabilities & Regulatory Compliance

• GMP-compliant manufacturing facilities with ongoing validation for international markets.
• Emphasizes process transparency and quality management.

Market Position
While newer to the LMWH segment, Techdow's large production capacity and competitive pricing make it a notable emerging supplier.

---

Regulatory Considerations in API Procurement

When sourcing dalteparin sodium API, compliance with international quality standards is paramount. Suppliers should have certifications such as:

• USP, EP, or JP monograph adherence for heparin products.
• GMP certification from relevant authorities (FDA, EMA, CFDA).
• Evidence of bioassay validation, impurity profiling, and consistent lot-to-lot uniformity.

Moreover, due diligence around traceability, purity, and residual details like endotoxin levels enhances drug safety and regulatory approval chances.

---

Supply Chain and Logistics Challenges

The complex synthesis of dalteparin sodium necessitates intricate logistics channels, often involving multiple countries for raw material sourcing and finished API shipment. Raw heparin sourced mainly from pig intestines must adhere to strict animal health and hygiene standards, adding layers of complexity.

Strategic planning around regulatory transitions and geopolitical factors, especially those impacting Chinese and US suppliers, is critical for uninterrupted supply.

---

Emerging Trends in API Sourcing for Dalteparin Sodium

• Vertical Integration: Companies like SPL and Chinese manufacturers increasingly vertically integrate raw material sourcing and manufacturing to ensure quality and supply stability.
• Enhanced Analytical Techniques: Adoption of advanced analytics (e.g., mass spectrometry, NMR) to improve quality control and meet regulatory expectations.
• Regional Diversification: Diversification of supply sources across Asia, North America, and Europe reduces dependency risks.
• Sustainable Practices: Growing emphasis on sustainable and ethically sourced raw materials, aligning with global standards and customer expectations.

---

Key Takeaways

• The majority of bulk dalteparin sodium API is supplied by Chinese manufacturers with extensive capacity and competitive pricing.
• Reputable players like SPL (USA/Europe), Changshan Biochemical, and Techdow offer high-quality API compliant with global regulatory standards.
• Due diligence on GMP certification, analytical validation, and traceability is essential for procurement.
• Supply chain resilience depends on diversification, strategic sourcing, and proactive regulatory compliance.
• Advances in API manufacturing technology and quality control bolster supply reliability amidst increasing global demand.

---

FAQs

1. What are the primary regions manufacturing dalteparin sodium API?
China dominates as the leading producer, with facilities also in the USA, Europe, and emerging players in India and Southeast Asia.

2. How do regulatory standards impact API quality for dalteparin sodium?
Adherence to GMP, EMA, and FDA standards ensures consistency, purity, and safety, influencing regulatory approval and market access.

3. Can I source dalteparin sodium API directly from Chinese manufacturers?
Yes, several Chinese firms operate GMP-certified facilities and export globally, provided proper due diligence and certification verification are conducted.

4. What quality attributes should I verify when selecting an API supplier?
Key attributes include purity levels, endotoxin content, molecular weight distribution, bioactivity assays, and certification compliance.

5. How sustainable are current supply chains for dalteparin sodium?
While the supply chain is robust, geopolitical tensions, raw material sourcing challenges, and increasing demand highlight the importance of diversification and contingency planning.

---

References:

[1] U.S. Pharmacopeia. Heparin and Low Molecular Weight Heparins. USP Monographs.
[2] European Pharmacopoeia. Heparin Sodium and LMWH. Pharmacopoeia Standards.
[3] Scientific Protein Laboratories. Product Information and Quality Data.
[4] Changshan Biochemical Pharmaceutical Co., Ltd. Website and Regulatory Documentation.
[5] Techdow. Company Profile and GMP Certification Details.