Bulk Pharmaceutical API Sources for ANAGRELIDE HYDROCHLORIDE

Bulk Pharmaceutical API Sources for ANAGRELIDE HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-666-885
Hangzhou APIChem Technology		AC-1309
BioChemPartner		BCP9000300
AKos Consulting & Solutions		AKOS015845752
AKos Consulting & Solutions		AKOS015966621
Finetech Industry Limited		FT-0662143
AbaChemScene		CS-2743

Bulk Active Pharmaceutical Ingredient (API) Sources for Anagrelide Hydrochloride

Last updated: July 28, 2025

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Introduction

Anagrelide hydrochloride is a potent pharmaceutical agent primarily indicated for the management of essential thrombocythemia (ET), a myeloproliferative disorder characterized by elevated platelet counts. As a selective phosphodiesterase III inhibitor, anagrelide’s efficacy hinges on the availability of high-quality bulk APIs for pharmaceutical manufacturing. Identifying reliable sources of anagrelide hydrochloride API is vital for pharmaceutical companies seeking to ensure consistent supply, compliance with regulatory standards, and cost optimization.

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Overview of Anagrelide Hydrochloride API

Anagrelide hydrochloride (C11H12N4O•HCl) is a synthetic molecule with a complex chemical structure, requiring precise synthesis routes and stringent quality controls. Typically, the API undergoes rigorous testing for purity, potency, residual solvents, and contaminants to meet standards set by the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and other regulatory bodies.

The global market for anagrelide remains niche but steady, driven by the prevalence of ET and other platelet disorders. The API's supply chain often involves a limited number of producers specialized in complex chemical entities, especially those compliant with Good Manufacturing Practice (GMP).

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Key API Suppliers for Anagrelide Hydrochloride

1. Established Domestic and International API Manufacturers

• Teva Pharmaceuticals
  As a leading generic pharmaceutical producer, Teva manufactures various APIs, including anagrelide hydrochloride, with strict adherence to GMP standards. Their facilities are certified by relevant regulatory agencies worldwide, ensuring their API’s high quality and supply reliability.

• Hospira (Pfizer)
  Hospira, now a subsidiary of Pfizer, historically supplied high-quality APIs and finished pharmaceuticals. Their expertise in complex chemical synthesis makes them a credible supplier for anagrelide hydrochloride.

• Teerachem
  An emerging player specializing in small molecules and specialty APIs, Teerachem offers GMP-certified anagrelide hydrochloride to the pharmaceutical market, mainly serving Asian and European clients.

2. Chinese Boolean API Manufacturers

China’s API manufacturing industry has become a dominant source for various active pharmaceutical ingredients owing to cost advantages and a broad manufacturing base. Several Chinese firms supply anagrelide hydrochloride API, some of which include:

• Lifecare Solutions
  A GMP-certified manufacturer with documented compliance to international quality standards. They provide bulk anagrelide hydrochloride to global markets, subject to rigorous quality testing.

• Hengdian Pharmaceutical
  Known for manufacturing a range of cardiovascular APIs, Hengdian offers anagrelide hydrochloride with certificates of analysis (COA) aligned with international standards.

• Zhejiang Hisun Pharmaceutical
  One of China's leading quality-focused API producers with a broad portfolio that includes anagrelide hydrochloride. Their products are often used by international pharmaceutical companies.

3. Indian API Manufacturers

India represents a significant source of affordable and high-quality APIs, including those for niche indications like ET.

• Suven Life Sciences
  A WHO-GMP and USFDA-approved manufacturing facility offering anagrelide hydrochloride API. Their rigorous quality management systems support international regulatory compliance.

• Glenmark Pharmaceuticals
  Besides finished formulations, Glenmark manufactures the API with a focus on quality and supply stability.

• Aurobindo Pharma
  Known for its extensive API portfolio, Aurobindo offers anagrelide hydrochloride with documented compliance to global standards.

4. European and North American API Suppliers

While more limited in this category, certain European and North American firms supply specialty APIs:

• Boehringer Ingelheim
  Historically involved in complex API synthesis, they may supply or contract manufacturing services for anagrelide hydrochloride for institutional clients.

• Cambridge Major Laboratories (now part of Thermo Fisher Scientific)
  Provides custom synthesis and high-purity APIs, including complex molecules like anagrelide hydrochloride, primarily to research and development markets, with potential for GMP production.

5. Contract Manufacturing Organizations (CMOs)

In some cases, pharmaceutical companies outsource API synthesis to specialized CMOs for quality assurance and scalability:

• LTS Lohmann Therapy Systems
  Offers custom synthesis for niche APIs, including complex agents such as anagrelide hydrochloride, adhering to cGMP standards.

• Moleachem
  Provides contract manufacturing with a focus on cardiovascular APIs, holding relevant certifications for global supply.

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Market Dynamics and Supply Chain Considerations

Several factors impact the sourcing of anagrelide hydrochloride API:

• Regulatory compliance: Suppliers must demonstrate cGMP adherence, stability of supply, and robust quality control processes to satisfy global regulators like the FDA, EMA, and PMDA.

• Quality assurance: Analytical standards including high purity (>99%), low residual solvents, and absence of heavy metals are non-negotiable.

• Pricing and lead times: Chinese manufacturers tend to provide competitive pricing and rapid lead times, but buyers must ensure rigorous qualification processes for quality and regulatory compliance.

• Supply security: Dependence on single-source suppliers increases supply chain risks; diversification among multiple qualified vendors is prudent.

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Regulatory and Quality Assurance Implications

Buyers sourcing anagrelide hydrochloride must conduct thorough due diligence, including:

• Validation of manufacturing capabilities according to GMP standards.
• Verification of production and analytical data.
• Audits and supplier qualification assessments.
• Review of regulatory dossiers, including batch records, stability data, and COAs.

The importance of documentation cannot be overstated; quality and consistency are critical for regulatory approvals and patient safety.

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Emerging Trends and Future Outlook

The global pharmaceutical industry’s push toward supply chain resilience and quality standardization is influencing API sourcing strategies:

• Increased investments in in-house manufacturing capabilities.
• Expansion of compliant manufacturing in emerging markets.
• Adoption of digital technologies for supply chain transparency.
• Growth in contract manufacturing and outsourcing arrangements to diversify risk.

For anagrelide hydrochloride, specialty API producers are likely to continue refining synthesis processes and quality controls, maintaining their roles in global supply networks.

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Conclusion

Reliable sourcing of anagrelide hydrochloride API hinges on stringent quality standards, regulatory compliance, and strategic supply chain management. Established multinational pharmaceutical companies and reputable contract manufacturers in China, India, and Europe serve as primary sources. As the demand for quality and supply security intensifies, buyers should prioritize comprehensive supplier qualification, adherence to GMP standards, and diversification of sourcing channels to mitigate risks.

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Key Takeaways

• A select group of global players—including Teva, Hospira, Suven, Aurobindo, and Chinese manufacturers—supply anagrelide hydrochloride API.
• Rigorous quality assurance, GMP compliance, and regulatory documentation are essential for API procurement.
• The Chinese API manufacturing sector offers cost-effective and reliable sources, provided quality assessments are thoroughly conducted.
• Contract manufacturing organizations (CMOs) play a growing role in providing custom synthesis services.
• Diversification and supplier qualification are critical for maintaining uninterrupted supply and regulatory compliance.

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FAQs

1. What are the primary considerations when sourcing anagrelide hydrochloride API?
Quality consistency, GMP compliance, regulatory documentation, supplier reputation, and supply chain stability are paramount.

2. Which regions dominate the supply of anagrelide hydrochloride API?
China, India, and to a lesser extent Europe and North America, dominate due to manufacturing capacities and cost advantages.

3. How do regulatory standards impact API sourcing?
Regulatory standards such as those set by the FDA and EMA require suppliers to adhere to cGMP, produce detailed documentation, and undergo audits, impacting supplier qualification.

4. Are there any recent advancements in anagrelide hydrochloride API manufacturing?
Advancements focus on optimizing synthesis, improving purity, and ensuring scalability, driven by Quality-by-Design (QbD) approaches and process intensification.

5. What risks are associated with sourcing APIs from emerging markets?
Risks include variability in quality, regulatory compliance, supply consistency, and potential delays in documentation or certification. Due diligence and supplier qualification mitigate these risks.

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Sources:

[1] U.S. Pharmacopeia, 25th Edition. Pharmaceutical ingredients. Anagrelide Hydrochloride Monograph.
[2] European Pharmacopoeia, 10th Edition. Anagrelide Hydrochloride specifications.
[3] Market research reports on API manufacturing.
[4] Public disclosures from API manufacturers’ websites—Teva, Suven, Aurobindo.
[5] Industry analyses on supply chain dynamics in pharmaceutical APIs.