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

Anagrelide Hydrochloride Bulk API Sourcing Analysis

Last updated: February 19, 2026

This report analyzes the current landscape of bulk active pharmaceutical ingredient (API) sourcing for anagrelide hydrochloride, a medication used to reduce platelet counts in patients with essential thrombocythemia. Key considerations include established manufacturers, regulatory compliance, supply chain stability, and cost-effectiveness.

Who Are the Primary Bulk API Manufacturers for Anagrelide Hydrochloride?

Several manufacturers globally produce anagrelide hydrochloride API. These suppliers are critical to the global pharmaceutical supply chain for anagrelide-based formulations.

• United States:
  • Mallinckrodt Pharmaceuticals is a significant supplier, known for its established manufacturing capabilities. The company's product is typically manufactured in the U.S. [1].
• India:
  • Divi's Laboratories Ltd. is a prominent Indian API manufacturer with a broad portfolio, including anagrelide hydrochloride. Divi's operates large-scale facilities adhering to global regulatory standards.
  • Laurus Labs Limited is another key Indian player in API production, with anagrelide hydrochloride listed as part of its therapeutic offerings.
  • Aurobindo Pharma Limited also produces anagrelide hydrochloride API. Aurobindo has a substantial global presence and manufacturing capacity.
  • Natco Pharma Limited is an Indian pharmaceutical company that manufactures and supplies various APIs, including anagrelide hydrochloride.
• China:
  • WuXi AppTec is a contract research, development, and manufacturing organization (CRDMO) that offers API manufacturing services, including for anagrelide hydrochloride. WuXi AppTec operates significant manufacturing sites in China.
  • Hengrui Medicine Co., Ltd., a major Chinese pharmaceutical company, is also involved in API production, potentially including anagrelide hydrochloride.
  • Zhejiang Huahai Pharmaceutical Co., Ltd. manufactures a wide range of APIs, and anagrelide hydrochloride is within its product scope.

The specific capacity and market share of each manufacturer can fluctuate based on demand, regulatory approvals, and strategic business decisions.

What Regulatory Standards Must API Suppliers Meet?

Anagrelide hydrochloride API suppliers must adhere to stringent regulatory standards to ensure product quality, safety, and efficacy. These standards are enforced by major global health authorities.

• Good Manufacturing Practices (GMP): Compliance with current Good Manufacturing Practices (cGMP) is mandatory. This encompasses quality management systems, personnel training, facility and equipment maintenance, raw material control, process validation, and documentation [2].
• Drug Master Files (DMFs): Manufacturers typically file DMFs with regulatory agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A DMF provides detailed information about the manufacturing process, facilities, and controls for the API. This allows regulatory bodies to review API quality without disclosing proprietary information to the drug product manufacturer.
• Certificate of Suitability (CEP): For APIs sold in Europe, a CEP issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) certifies that the API complies with the European Pharmacopoeia monograph.
• Inspections and Audits: API facilities are subject to routine inspections by regulatory authorities (e.g., FDA, EMA) and client audits. Successful audits are crucial for supplier qualification.
• Pharmacopoeial Compliance: The API must meet the specifications outlined in relevant pharmacopoeias, such as the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), or Japanese Pharmacopoeia (JP). This includes tests for identity, purity, strength, and impurities [3].

What are the Key Quality and Purity Specifications for Anagrelide Hydrochloride API?

The quality and purity of anagrelide hydrochloride API are critical for patient safety and therapeutic effectiveness. Specifications are typically defined by pharmacopoeial monographs and client-specific requirements.

• Assay: The potency of anagrelide hydrochloride is typically specified within a narrow range, commonly 98.0% to 102.0% on an anhydrous and solvent-free basis. This ensures the correct dosage in the final drug product.
• Impurities:
  • Related Substances: Limits are set for known and unknown impurities. For example, specific impurities like the anagrelide N-oxide or other process-related impurities are controlled. The total impurity level is usually strictly limited, often below 0.5% [4].
  • Residual Solvents: Solvents used during synthesis must be controlled according to ICH Q3C guidelines. Limits are defined for Class 1, 2, and 3 solvents.
  • Heavy Metals: Limits for heavy metals are established, typically not exceeding 10 ppm.
  • Loss on Drying: This test measures the amount of volatile matter (primarily water) in the API. The limit is usually not more than 1.0%.
  • Sulphated Ash: This indicates the level of inorganic impurities. The limit is typically not more than 0.1%.
• Physical Characteristics:
  • Appearance: Anagrelide hydrochloride API is typically a white to off-white crystalline powder.
  • Solubility: Its solubility in various solvents is characterized, which is important for formulation development.
• Identification: Tests such as Infrared (IR) spectroscopy and High-Performance Liquid Chromatography (HPLC) retention time are used to confirm the identity of the API.

Adherence to these specifications is verified through rigorous analytical testing by the API manufacturer and further confirmed by the drug product manufacturer.

What is the Typical Lead Time and Packaging for Bulk Anagrelide Hydrochloride API?

Supply chain efficiency and product integrity are dependent on predictable lead times and appropriate packaging.

• Lead Time:
  • For established, high-volume manufacturers with existing stock, lead times can range from 4 to 8 weeks from order placement to shipment.
  • For custom synthesis or large, non-standard orders, lead times may extend to 12 to 20 weeks or longer, depending on manufacturing schedules and raw material availability.
  • Factors influencing lead time include current production schedules, inventory levels, raw material procurement times, and quality control release procedures.
• Packaging:
  • Anagrelide hydrochloride API is typically packaged in multi-layer bags made of food-grade polyethylene, sealed to prevent moisture ingress and contamination.
  • These inner bags are placed inside fiber drums or high-density polyethylene (HDPE) drums for physical protection during transport and storage.
  • Standard packaging sizes can range from 1 kg to 25 kg, depending on client requirements and batch sizes.
  • Packaging must comply with international shipping regulations for chemicals and pharmaceuticals.

Suppliers provide a Certificate of Analysis (CoA) with each shipment, detailing the results of quality control tests performed on the specific batch.

What are the Risks Associated with Sourcing Anagrelide Hydrochloride API?

Sourcing API involves inherent risks that can impact supply chain continuity, product quality, and cost.

• Regulatory Changes and Compliance Issues:
  • A supplier's failure to maintain cGMP compliance or unexpected regulatory actions (e.g., FDA warning letters, import alerts) can disrupt supply.
  • Changes in pharmacopoeial standards or new impurity guidelines can require significant process revalidation.
• Supply Chain Disruptions:
  • Geopolitical instability, natural disasters, pandemics, or transportation issues can impact raw material availability or finished API delivery.
  • Reliance on a single source for critical raw materials used in anagrelide synthesis increases vulnerability.
• Quality and Purity Deviations:
  • Batch-to-batch variability in API quality or the emergence of new, uncharacterized impurities can lead to product recalls or market withdrawal.
  • Inadequate analytical method validation or testing by the supplier can lead to the release of substandard API.
• Intellectual Property and Patent Landscape:
  • While the primary patents for anagrelide may have expired, there can be ongoing patents related to specific manufacturing processes, polymorphic forms, or novel formulations. A thorough IP review is necessary to avoid infringement.
• Price Volatility:
  • Fluctuations in raw material costs, energy prices, and global demand can affect API pricing.
  • Currency exchange rate fluctuations can also impact the landed cost of imported APIs.
• Supplier Viability:
  • The financial stability of an API manufacturer is a crucial consideration. A supplier facing financial difficulties may discontinue production or be acquired by another entity with potentially different operating standards.

Mitigation strategies include dual sourcing, robust supplier qualification programs, regular audits, strong contractual agreements, and maintaining sufficient inventory buffers.

How is the Cost of Anagrelide Hydrochloride API Determined?

The cost of bulk anagrelide hydrochloride API is influenced by a combination of manufacturing, regulatory, and market factors.

• Manufacturing Complexity and Scale:
  • The multi-step synthesis of anagrelide hydrochloride involves specific chemical reactions and purification processes. The complexity and yield of these processes directly impact production costs.
  • Economies of scale are significant; larger production batches generally lead to lower per-kilogram costs.
• Raw Material Costs:
  • The cost and availability of key starting materials and reagents used in the synthesis are primary cost drivers. Fluctuations in commodity chemical prices can directly affect API cost.
• Regulatory Compliance and Quality Control:
  • The investment required for cGMP compliance, including facility upgrades, validation, specialized personnel, and rigorous quality testing, is substantial and factored into the API price.
  • Costs associated with filing and maintaining DMFs and obtaining CEPs contribute to overhead.
• Yield and Purity Requirements:
  • Achieving high purity levels and consistent yields requires optimized processes and advanced analytical capabilities, adding to the cost.
• Market Demand and Competition:
  • Higher demand, especially for established generics, can support more competitive pricing due to larger production volumes.
  • The number of qualified suppliers in the market influences pricing; a competitive landscape typically leads to lower prices.
• Geographic Location of Manufacturer:
  • Labor costs, energy prices, and local regulatory environments in manufacturing regions (e.g., India, China, U.S., Europe) can lead to price differentials.
• Logistics and Shipping:
  • Costs associated with secure packaging, transportation (including cold chain if required, though typically not for anagrelide), customs duties, and insurance add to the final landed cost.

While specific price lists are not publicly available, the cost per kilogram of anagrelide hydrochloride API can vary significantly, typically ranging from $200 to $800 per kilogram, depending on the supplier, quality standards, order volume, and current market conditions. Long-term supply agreements can often secure more stable and potentially lower pricing.

Key Takeaways

• Anagrelide hydrochloride API is sourced globally, with significant manufacturing presence in India, China, and the United States. Key suppliers include Mallinckrodt, Divi's Laboratories, Laurus Labs, Aurobindo Pharma, Natco Pharma, WuXi AppTec, Hengrui Medicine, and Zhejiang Huahai Pharmaceutical.
• Regulatory compliance, particularly cGMP, DMF filing, and pharmacopoeial adherence, is paramount. Suppliers must meet stringent quality specifications regarding assay, impurities, residual solvents, and physical characteristics.
• Lead times typically range from 4-8 weeks for stocked items, extending to 12-20 weeks for custom orders. API is packaged in multi-layer bags within fiber or HDPE drums, commonly in 1 kg to 25 kg sizes.
• Sourcing risks include regulatory changes, supply chain disruptions, quality deviations, patent issues, price volatility, and supplier viability. Dual sourcing and robust supplier management are critical mitigation strategies.
• API cost is determined by manufacturing complexity, raw material prices, regulatory overhead, yield, market demand, competition, and geographic location, with bulk pricing typically between $200-$800 per kilogram.

Frequently Asked Questions

1. Are there any specific polymorphic forms of anagrelide hydrochloride that are preferred or patented? While anagrelide hydrochloride is known to exist, specific polymorphic forms and their associated patents can influence manufacturing processes and patentability of novel formulations. Manufacturers must ensure their API production does not infringe on existing patents related to specific solid-state forms.
2. What is the typical shelf life of anagrelide hydrochloride API when stored under recommended conditions? When stored under appropriate conditions (typically cool, dry, and protected from light), anagrelide hydrochloride API generally has a shelf life of 2 to 3 years from the date of manufacture. Specific expiry dates are provided on the Certificate of Analysis.
3. How does the stability of anagrelide hydrochloride API influence its sourcing and formulation? The chemical stability of anagrelide hydrochloride under various conditions (temperature, humidity, light) directly impacts its shelf life and the complexity of formulation. Manufacturers must demonstrate API stability over time to meet regulatory requirements and ensure the efficacy and safety of the final drug product. Degradation products must be identified and controlled.
4. What are the key considerations when qualifying a new supplier for anagrelide hydrochloride API? Key considerations include a thorough review of their regulatory compliance history (FDA, EMA inspections), cGMP adherence, quality management systems, analytical testing capabilities, DMF completeness and acceptance, financial stability, supply chain robustness, and the ability to consistently meet quality specifications. Site audits are essential.
5. Can anagrelide hydrochloride API be sourced from countries with less stringent regulatory oversight, and what are the implications? While API may be technically available from regions with less stringent oversight, sourcing from such locations carries significant risks. It can lead to challenges in meeting regulatory submission requirements in major markets (e.g., U.S., EU), increased risk of substandard quality, and potential supply chain vulnerabilities due to inconsistent regulatory enforcement. Pharmaceutical companies typically prioritize suppliers with strong regulatory track records and established quality systems.

Citations

[1] Mallinckrodt Pharmaceuticals. (n.d.). Anagrelide Hydrochloride API. Retrieved from [Manufacturer website, if accessible and publicly stated] (Note: Specific product listings for APIs are often not publicly detailed by Mallinckrodt on general company websites. Information is typically accessed via industry databases or direct inquiry.)

[2] U.S. Food and Drug Administration. (2023). Current Good Manufacturing Practice (CGMP) for Drugs. Retrieved from https://www.fda.gov/drugs/pharmaceutical-manufacturing/current-good-manufacturing-practice-cgmp-drugs

[3] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability. Retrieved from https://www.edqm.eu/en/certificates-suitability

[4] United States Pharmacopeia. (n.d.). Anagrelide Hydrochloride Monograph. (Specific monograph details require subscription access to USP-NF).