Bulk Pharmaceutical API Sources for QUILLICHEW ER

Bulk Pharmaceutical API Sources for QUILLICHEW ER

Vendor	Vendor Homepage	Vendor Sku	API Url
Sigma-Aldrich		M2892_SIGMA
AKos Consulting & Solutions		AKOS016010356
Finetech Industry Limited		FT-0672045
Finetech Industry Limited		FT-0672046
Finetech Industry Limited		FT-0672048

API Sources for QUILLICHEW ER

Last updated: February 19, 2026

Quillichew ER is an extended-release chewable tablet formulation of guanfacine hydrochloride, indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years. The bulk active pharmaceutical ingredient (API) for Quillichew ER is guanfacine hydrochloride. Sourcing this API requires adherence to stringent regulatory standards, including Good Manufacturing Practices (GMP) and quality agreements. The global market for guanfacine hydrochloride API is supplied by multiple manufacturers, primarily located in China and India, with some presence in Europe and North America. Pricing and availability are subject to market demand, production capacity, and regulatory compliance.

What is the chemical name and CAS number for Guanfacine Hydrochloride?

The chemical name for guanfacine hydrochloride is N-(aminoiminomethyl)-2,1,2-diazabicyclo[3.1.0]hex-2-en-6-ylmethanamide hydrochloride. Its CAS Registry Number is 55120-77-9. This information is critical for identifying and procuring the correct API. Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require precise identification of APIs for drug product registration and quality control.

Who are the primary manufacturers of Guanfacine Hydrochloride API?

The global supply chain for guanfacine hydrochloride API is concentrated among a limited number of manufacturers. These suppliers must demonstrate robust quality management systems and compliance with international regulatory standards.

• China: Manufacturers in China are significant contributors to the global API supply. Companies like Zhejiang Huahai Pharmaceutical Co., Ltd., and Zhejiang NHU Co., Ltd., are known producers of guanfacine hydrochloride. These entities often leverage economies of scale to offer competitive pricing.
• India: Indian pharmaceutical manufacturers also play a key role. Companies such as Lupin Limited and Dr. Reddy's Laboratories have the capacity to produce various APIs, including guanfacine hydrochloride. The Indian pharmaceutical industry is recognized for its strong regulatory adherence and export capabilities.
• Europe and North America: While production volume may be lower compared to Asia, some European and North American companies also manufacture guanfacine hydrochloride API, often focusing on niche markets or specialized quality requirements.

The selection of an API manufacturer is a critical decision for pharmaceutical companies. It involves rigorous due diligence, including site audits, review of regulatory filings (e.g., Drug Master Files, DMFs), and confirmation of adherence to GMP.

What are the regulatory requirements for API sourcing?

Sourcing guanfacine hydrochloride API for pharmaceutical manufacturing is governed by strict regulatory frameworks to ensure product safety, efficacy, and quality. Key requirements include:

• Good Manufacturing Practices (GMP): API manufacturers must comply with GMP guidelines established by regulatory authorities like the FDA (21 CFR Parts 210 and 211) and EMA (EudraLex Volume 4). These guidelines cover all aspects of production, including facility design, equipment, personnel, raw material control, process validation, and quality control testing.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. A DMF is a submission to a regulatory agency from a drug manufacturer that provides confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. Pharmaceutical companies referencing a DMF in their drug product applications can rely on the quality and manufacturing information without needing to disclose proprietary data themselves.
• Quality Agreements: A legally binding quality agreement between the drug product manufacturer and the API supplier is essential. This agreement details the responsibilities of each party regarding quality control, change management, batch release, investigations, and audits.
• ICH Guidelines: International Council for Harmonisation (ICH) guidelines, such as ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients), provide harmonized standards for API manufacturing that are recognized by major regulatory bodies.
• Supply Chain Security and Traceability: Ensuring the integrity and traceability of the API throughout the supply chain is paramount. This includes measures to prevent counterfeiting and diversion.

How is the quality of Guanfacine Hydrochloride API assessed?

The quality of guanfacine hydrochloride API is assessed through a battery of tests to confirm its identity, purity, strength, and quality. These assessments are based on pharmacopoeial standards and the manufacturer's validated analytical methods.

• Identity Tests:
  • Infrared (IR) Spectroscopy: Compares the IR spectrum of the sample to a reference standard.
  • Ultraviolet (UV) Spectroscopy: Measures absorbance at specific wavelengths.
  • High-Performance Liquid Chromatography (HPLC): Retention time matching with a reference standard.
• Purity Tests:
  • Related Substances (HPLC): Detects and quantifies impurities, including process-related impurities and degradation products. Limits for individual and total impurities are set by pharmacopoeias and regulatory filings.
  • Residual Solvents (Gas Chromatography, GC): Measures residual amounts of solvents used during synthesis, ensuring they are below acceptable limits as defined by ICH Q3C.
  • Heavy Metals: Assesses for contamination by heavy metals, which can be toxic.
  • Water Content (Karl Fischer Titration): Determines the moisture content, which can affect API stability.
  • Sulphated Ash: Measures the inorganic residue left after ignition, indicating inorganic impurities.
• Assay (Potency):
  • HPLC or Titration: Quantifies the guanfacine hydrochloride content, typically expressed as a percentage on a dried or anhydrous basis. The assay specification is usually within a narrow range, for example, 98.0% to 102.0%.
• Physical Properties:
  • Appearance: Visual inspection for color and form.
  • Solubility: Assesses solubility in specified solvents.
  • Particle Size Distribution: Relevant for solid dosage forms, affecting dissolution and bioavailability.

These tests are performed on each batch of API before it is released for use in drug product manufacturing. Certificates of Analysis (CoAs) from the API manufacturer detail the results of these tests for each delivered batch.

What is the typical market pricing and availability for Guanfacine Hydrochloride API?

The market pricing and availability for guanfacine hydrochloride API are dynamic and influenced by several factors:

• Production Volume and Capacity: Manufacturers with large-scale production facilities can typically offer more competitive pricing due to economies of scale. Fluctuations in global demand can also impact availability.
• Regulatory Compliance and Quality Standards: API sourced from manufacturers with a proven track record of regulatory compliance and robust quality systems may command higher prices. The cost associated with maintaining these standards is factored into the pricing.
• Geopolitical Factors and Supply Chain Disruptions: Global events, trade policies, and supply chain disruptions (e.g., pandemics, shipping issues) can significantly affect both the price and availability of APIs.
• Competition: The number of qualified suppliers in the market influences pricing. Increased competition generally leads to lower prices, while a consolidated market can result in higher costs.

While specific pricing data is proprietary and fluctuates, industry reports and market intelligence suggest that bulk guanfacine hydrochloride API can range from $200 to $1,000 per kilogram, depending on the supplier, quality grade, order volume, and current market conditions. Availability is generally good, with established suppliers able to meet demand. However, for critical drug products, securing supply agreements with multiple qualified vendors is a standard risk mitigation strategy.

What are the key considerations for selecting an API supplier?

Selecting a reliable supplier for guanfacine hydrochloride API is crucial for ensuring the consistent quality and market supply of Quillichew ER. Key considerations include:

• Regulatory Compliance: The supplier must have a strong regulatory history, including successful FDA inspections and EMA audits. A filed DMF that is accepted by regulatory authorities is a prerequisite.
• Quality Management System (QMS): A well-documented and implemented QMS that adheres to ICH Q7 and other relevant GMP guidelines is essential. This includes robust change control procedures, deviation management, and CAPA systems.
• Manufacturing Capabilities and Capacity: The supplier must possess the technical expertise and manufacturing capacity to produce API at the required scale and consistently meet quality specifications. Scalability to meet future demand increases is also important.
• Analytical Capabilities: The supplier's in-house analytical laboratories should be well-equipped and capable of performing all required quality control tests according to validated methods.
• Supply Chain Reliability and Risk Management: The supplier should demonstrate a secure and transparent supply chain, with contingency plans in place to mitigate potential disruptions. Audits of key raw material suppliers may also be necessary.
• Financial Stability: The long-term financial health of the supplier is important to ensure sustained production and supply.
• Technical Support and Responsiveness: Effective communication channels and responsive technical support are vital for addressing queries, resolving issues, and managing changes.
• Intellectual Property (IP) Protection: Ensuring the supplier respects and protects the IP of the drug product manufacturer is a critical, albeit often implicit, consideration.

Due diligence often involves site audits, review of quality documentation, and thorough evaluation of the supplier's regulatory and commercial history.

What are potential risks associated with API sourcing for Quillichew ER?

Several risks are associated with sourcing guanfacine hydrochloride API that can impact the manufacturing and market availability of Quillichew ER:

• Quality Failures: Deviations from GMP or inadequate quality control can lead to API batches that do not meet specifications. This can result in rejected batches, production delays, and potential product recalls if non-conforming API has already been incorporated into drug products.
• Supply Chain Disruptions: Reliance on a single supplier or geographic region for API exposes the supply chain to risks such as natural disasters, geopolitical instability, trade disputes, or regulatory changes in the supplier's country.
• Regulatory Non-Compliance: Changes in regulatory requirements or failure of an API supplier to maintain compliance can lead to import alerts, suspension of DMFs, or other actions that disrupt supply.
• Price Volatility: Fluctuations in raw material costs, energy prices, and global market demand can lead to significant price increases for the API, impacting the cost of goods for Quillichew ER.
• Intellectual Property (IP) Infringement: While less common for generic APIs, there is a risk of sourcing API from entities that may infringe on existing patents or proprietary manufacturing processes, leading to legal challenges.
• Counterfeiting and Adulteration: The risk of counterfeit or adulterated API entering the supply chain, particularly from less regulated sources, poses a serious threat to patient safety and product integrity.
• Supplier Insolvency: The financial failure of a key API supplier can abruptly halt production, requiring a rapid and potentially disruptive transition to an alternative vendor.

Mitigation strategies include dual sourcing, rigorous supplier qualification and monitoring, maintaining robust quality agreements, building strategic inventory levels, and staying informed about global regulatory and market trends.

Key Takeaways

• Guanfacine hydrochloride is the active pharmaceutical ingredient for Quillichew ER.
• Major API suppliers are located in China and India, with some presence in Europe and North America.
• Sourcing requires strict adherence to GMP, supported by Drug Master Files and comprehensive quality agreements.
• API quality is assessed through identity, purity, and assay testing, adhering to pharmacopoeial standards.
• Pricing for guanfacine hydrochloride API can range from $200 to $1,000 per kilogram, influenced by production volume, quality, and market dynamics.
• Key supplier selection criteria include regulatory compliance, quality management systems, manufacturing capacity, and supply chain reliability.
• Risks in API sourcing include quality failures, supply chain disruptions, regulatory non-compliance, and price volatility.

Frequently Asked Questions

1. What is the primary function of guanfacine hydrochloride in Quillichew ER? Guanfacine hydrochloride is an alpha-2A adrenergic receptor agonist that functions as the active pharmaceutical ingredient in Quillichew ER, treating attention-deficit/hyperactivity disorder (ADHD).

2. Are there specific pharmacopoeias that set standards for Guanfacine Hydrochloride API? Yes, major pharmacopoeias such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.) provide monographs that define the quality standards, tests, and acceptance criteria for guanfacine hydrochloride API.

3. What is the typical shelf life of Guanfacine Hydrochloride API? The typical shelf life of guanfacine hydrochloride API is usually between 2 to 5 years when stored under recommended conditions, as determined by stability studies conducted by the manufacturer.

4. How does the extended-release formulation of Quillichew ER influence API sourcing requirements? The extended-release formulation does not directly alter the fundamental requirements for the guanfacine hydrochloride API itself (e.g., purity, identity). However, the physical properties of the API, such as particle size distribution and flow characteristics, can become more critical considerations during formulation development to ensure consistent drug release profiles.

5. What are the implications of an FDA import alert on a Guanfacine Hydrochloride API supplier? An FDA import alert prohibits the entry of products from a named manufacturer or facility into the United States. If a Quillichew ER manufacturer relies on an API supplier subject to an import alert, it would necessitate a rapid and complex change of supplier to avoid disruptions in the U.S. market supply.

Citations

[1] U.S. Food and Drug Administration. (n.d.). 21 CFR Part 210 - Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; General. U.S. Government Publishing Office.

[2] U.S. Food and Drug Administration. (n.d.). 21 CFR Part 211 - Current Good Manufacturing Practice For Finished Pharmaceuticals. U.S. Government Publishing Office.

[3] European Medicines Agency. (2010). EudraLex - The Rules Governing Medicinal Products in the European Union, Volume 4 - Good Manufacturing Practice. European Commission.

[4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2009). ICH Harmonised Tripartite Guideline - Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients Q7.

[5] United States Pharmacopeial Convention. (n.d.). Guanfacine Hydrochloride (USP Monograph). In United States Pharmacopeia.

[6] European Directorate for the Quality of Medicines & HealthCare. (n.d.). European Pharmacopoeia. Council of Europe.