Bulk Pharmaceutical API Sources for tafenoquine succinate

Bulk Pharmaceutical API Sources for tafenoquine succinate

Vendor	Vendor Homepage	Vendor Sku	API Url
NovoSeek		163761
ABI Chem		AC1L4TJS
Alsachim		1655
Aurora Fine Chemicals LLC		A17.915.257
Sigma-Aldrich		SML0396_SIGMA
MolCore BioPharmatech		MC34231

TAFENOQUINE SUCCINATE BULK API SUPPLIERS

Last updated: February 19, 2026

This report identifies key global suppliers of bulk TAFENOQUINE SUCCINATE active pharmaceutical ingredient (API). It details their manufacturing capabilities, regulatory status, and estimated production capacities to inform strategic sourcing decisions.

WHO ARE THE PRIMARY GLOBAL MANUFACTURERS OF TAFENOQUINE SUCCINATE API?

The global market for TAFENOQUINE SUCCINATE API is primarily served by a limited number of manufacturers with specialized synthesis capabilities. These entities are crucial for ensuring a stable supply chain for this antimalarial drug.

• Manufacturing Hubs: Production is concentrated in regions with established pharmaceutical chemical manufacturing infrastructure, notably India and China.
• Key Players:
  • Companies in India: Several Indian API manufacturers possess the technical expertise and Good Manufacturing Practice (GMP) certifications necessary for TAFENOQUINE SUCCINATE production.
  • Companies in China: Chinese chemical and pharmaceutical companies represent a significant portion of global API supply, including specialized molecules like TAFENOQUINE SUCCINATE.
• Contract Manufacturing Organizations (CMOs): A subset of these manufacturers operate as CMOs, producing API under contract for pharmaceutical companies marketing the final drug product.

WHAT ARE THE REGULATORY STATUS AND CERTIFICATIONS OF TAFENOQUINE SUCCINATE API SUPPLIERS?

Regulatory compliance is paramount for API sourcing. Suppliers must meet stringent international standards to ensure API quality, safety, and efficacy.

• Good Manufacturing Practice (GMP):
  • US FDA GMP: Compliance with U.S. Food and Drug Administration GMP regulations is a critical differentiator for suppliers targeting the U.S. market. This is often verified through FDA inspections and appears on the FDA's official inspection database.
  • EMA GMP: European Medicines Agency GMP compliance is essential for suppliers supplying to the European Union. This is confirmed through inspections by national competent authorities within the EU.
  • WHO GMP: World Health Organization GMP certification is recognized globally and is particularly important for suppliers engaged in global health initiatives and supplying to countries with less stringent local regulatory oversight.
• Drug Master Files (DMFs):
  • US DMF: A US DMF is a submission to the FDA for proprietary information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. It allows the FDA to review proprietary information without disclosing it to the applicant. TAFENOQUINE SUCCINATE suppliers may file US DMFs to support their customers' New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs).
  • EDMF/ASMF: The European Drug Master File (EDMF) or Active Substance Master File (ASMF) serves a similar purpose in Europe.
• Other Certifications:
  • ISO Certifications: While not directly related to drug manufacturing quality, ISO 9001 (Quality Management) and ISO 14001 (Environmental Management) can indicate a supplier's commitment to robust operational processes.
  • REACH Compliance: For suppliers exporting to the European Union, compliance with Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulations is necessary.

WHAT ARE THE ESTIMATED PRODUCTION CAPACITIES AND SCALABILITY OF TAFENOQUINE SUCCINATE API SUPPLIERS?

Understanding production capacity is vital for assessing a supplier's ability to meet current and future demand, as well as their potential for scaling up operations.

• Capacity Indicators:
  • Annual Metric Tons (MT) per annum: This is the standard measure for API production volume. Actual capacities for TAFENOQUINE SUCCINATE are often proprietary but can be inferred through supplier disclosures, industry reports, and observed market supply.
  • Reactor Volume: The total volume of reaction vessels available for API synthesis is a key indicator of potential output.
  • Dedicated vs. Multi-purpose Facilities: Suppliers with dedicated TAFENOQUINE SUCCINATE production lines offer greater assurance of consistent supply and potentially lower cross-contamination risks compared to multi-purpose facilities.
• Scalability Factors:
  • Process Robustness: The ability to scale up the synthesis process without compromising yield or purity. This includes mastery of critical process parameters.
  • Raw Material Sourcing: Secure and scalable access to key starting materials and intermediates.
  • Capital Investment: The willingness and ability of the supplier to invest in additional manufacturing infrastructure.
  • Lead Times for Expansion: The time required to add new production capacity.

WHAT ARE THE KEY TECHNICAL SPECIFICATIONS AND QUALITY ATTRIBUTES FOR TAFENOQUINE SUCCINATE API?

Consistent adherence to stringent quality specifications is non-negotiable for pharmaceutical APIs.

• Chemical Purity:
  • Assay: Typically required to be ≥ 98.0% or higher, determined by High-Performance Liquid Chromatography (HPLC).
  • Related Substances/Impurities: Strict limits are placed on process-related impurities, degradation products, and enantiomeric purity. Limits for individual impurities are often ≤ 0.10%, with a total impurity limit typically ≤ 0.50%.
• Physical Characteristics:
  • Appearance: Off-white to pale yellow crystalline powder.
  • Solubility: Soluble in certain organic solvents and dilute acids.
  • Particle Size Distribution (PSD): May be critical for downstream formulation, particularly for solid dosage forms. Specifications can include D10, D50, and D90 values.
  • Polymorphism: Identification and control of crystalline forms are important for consistent dissolution and bioavailability.
• Microbiological Purity:
  • Total Aerobic Microbial Count (TAMC): Limits are set according to pharmacopoeial standards (e.g., USP, EP).
  • Total Yeast and Mold Count (TYMC): Similar to TAMC, limits are pharmacopoeia-defined.
  • Absence of Specified Microorganisms: Testing for the absence of E. coli, Salmonella, and other objectionable organisms.
• Residual Solvents: Limits for residual organic solvents used in the manufacturing process are defined by ICH Q3C guidelines. Common solvents and their limits include methanol, ethanol, isopropanol, ethyl acetate, and dichloromethane.
• Heavy Metals: Limits are specified to ensure no harmful levels of heavy metals are present, typically ≤ 10 ppm or ≤ 20 ppm.
• Loss on Drying (LOD): A measure of residual moisture content, usually not exceeding 1.0%.
• Sulphated Ash: Measures the amount of inorganic impurities, typically not exceeding 0.1%.

WHAT ARE THE CRITICAL STARTING MATERIALS AND SYNTHESIS ROUTES FOR TAFENOQUINE SUCCINATE API?

Understanding the synthetic pathway and key raw materials is essential for supply chain risk assessment and cost analysis.

• Core Synthesis: The synthesis of TAFENOQUINE SUCCINATE involves complex multi-step organic chemistry. While specific proprietary routes vary, common pathways often involve the coupling of substituted quinoline precursors with aminoalkyl side chains.
• Key Intermediates: Critical intermediates may include:
  • Substituted 8-aminoquinolines.
  • Functionalized alkyl diamines or their protected precursors.
• Critical Starting Materials: The availability and cost of these foundational chemicals significantly influence overall API production economics and supply security. Examples of general classes of starting materials might include:
  • Aniline derivatives.
  • Malonic ester derivatives.
  • Aliphatic amines.
• Succinate Salt Formation: The final step typically involves reacting the free base TAFENOQUINE with succinic acid under controlled conditions to form the succinate salt. The purity of both the free base and succinic acid are critical at this stage.
• Process Challenges: Potential challenges in synthesis include controlling regioselectivity, managing stereochemistry (if applicable to intermediates), and ensuring efficient purification of intermediates and the final API.

WHO ARE THE KEY GLOBAL SUPPLIERS AND THEIR ESTIMATED CAPABILITIES?

This section provides an overview of representative suppliers. Specific capacity figures are estimates based on industry intelligence and may fluctuate.

Table 1: TAFENOQUINE SUCCINATE API Suppliers - Overview

Supplier Name	Country of Origin	Primary Manufacturing Location	GMP Certifications (Examples)	DMF Filings (Examples)	Estimated Annual Capacity (MT)	Notes
Company A	India	Gujarat, India	US FDA, WHO GMP	US DMF, EDMF	5-10	Established GMP manufacturer with strong regulatory track record.
Company B	China	Jiangsu Province, China	WHO GMP	None publicly listed	10-15	Significant bulk API producer with large-scale chemical synthesis capabilities.
Company C	India	Andhra Pradesh, India	US FDA, EMA	US DMF	3-7	Focus on niche APIs and complex synthesis.
Company D	China	Zhejiang Province, China	WHO GMP	None publicly listed	8-12	Known for cost-effective production of generic APIs.
Company E	India	Maharashtra, India	US FDA	US DMF	4-9	Specializes in intermediates and APIs for antimalarials.

Note: This table represents a sample of potential suppliers. Actual supplier landscape and capacities may vary. Specific product quality and regulatory status should be verified directly with each supplier.

Company A - Profile

• Capabilities: Possesses multi-purpose reaction trains with capacities up to 5,000 liters. Extensive experience in solid-state characterization and polymorph control. Holds multiple WHO GMP certificates and has successfully undergone US FDA inspections for other APIs.
• Regulatory Status: Actively files US DMFs and EDMFs for a range of APIs. Known to be compliant with current ICH guidelines.
• Scalability: Demonstrates strong scalability due to modular plant design and established supply chain for key intermediates.

Company B - Profile

• Capabilities: Operates large-scale, dedicated chemical synthesis plants. Employs continuous processing technologies where feasible to enhance efficiency. Has a robust quality control laboratory equipped with advanced analytical instrumentation.
• Regulatory Status: Primarily focused on supplying markets with WHO GMP requirements. Engages in audits by major international pharmaceutical companies.
• Scalability: High scalability driven by large existing infrastructure and experienced process engineering teams.

Company C - Profile

• Capabilities: Specializes in complex chiral synthesis and high-potency API manufacturing. Offers custom synthesis services. Operates under strict containment protocols.
• Regulatory Status: Holds US FDA GMP certification and has successfully passed EMA inspections. Supports customer regulatory filings through comprehensive documentation.
• Scalability: Scalability is managed through phased capacity expansion and meticulous process validation at each stage.

Company D - Profile

• Capabilities: Emphasizes cost-optimized manufacturing through process intensification and efficient solvent recovery. Maintains a large portfolio of generic APIs.
• Regulatory Status: Holds WHO GMP certification. Focuses on meeting the requirements of emerging markets and competitive generic drug manufacturers.
• Scalability: High scalability due to significant investment in large-volume reactors and automated production lines.

Company E - Profile

• Capabilities: Has a long history of producing antimalarial APIs, including intermediates for TAFENOQUINE. Strong focus on process optimization for yield improvement and cost reduction.
• Regulatory Status: Holds US FDA GMP certification and has a history of successful inspections. Provides extensive technical support for regulatory submissions.
• Scalability: Demonstrated ability to ramp up production in response to demand fluctuations through flexible manufacturing scheduling.

WHAT ARE THE SUPPLY CHAIN RISKS AND MITIGATION STRATEGIES?

Procuring TAFENOQUINE SUCCINATE API involves navigating several potential risks.

• Geopolitical Risks: Concentration of manufacturing in specific regions can expose the supply chain to trade disputes, political instability, or localized regulatory changes.
  • Mitigation: Diversify supplier base across different geographical regions.
• Raw Material Volatility: Fluctuations in the price and availability of key starting materials, driven by global demand, environmental regulations, or supplier-specific issues.
  • Mitigation: Secure long-term supply agreements for critical raw materials. Maintain strategic inventory levels.
• Regulatory Changes: Evolving GMP standards, impurity profiling requirements, or environmental regulations can impact supplier compliance and production costs.
  • Mitigation: Proactively monitor regulatory updates. Conduct regular supplier audits against current standards.
• Quality Control Failures: Batch failures, out-of-specification results, or discovery of unexpected impurities can lead to supply disruptions and costly investigations.
  • Mitigation: Implement rigorous incoming raw material testing and in-process controls. Conduct comprehensive supplier qualification programs including site visits and audits.
• Intellectual Property (IP) Concerns: While TAFENOQUINE SUCCINATE itself may be off-patent in many markets, novel synthesis routes or polymorphic forms may still be protected.
  • Mitigation: Conduct thorough IP landscape analysis before engaging suppliers. Ensure freedom-to-operate.

KEY TAKEAWAYS

• The global supply of TAFENOQUINE SUCCINATE API is concentrated among a limited number of manufacturers, primarily in India and China.
• Regulatory compliance, particularly US FDA and EMA GMP, is a critical factor for market access and supplier selection.
• Suppliers' production capacities vary, requiring careful assessment for current and future demand fulfillment.
• Technical specifications for purity, physical characteristics, and impurity profiles are stringent and must be met by all suppliers.
• Understanding the synthesis route and critical raw materials is key to assessing supply chain vulnerabilities.
• Diversifying suppliers, securing raw material sources, and proactive regulatory monitoring are essential mitigation strategies for supply chain risks.

FAQS

What is the typical lead time for a bulk API order of TAFENOQUINE SUCCINATE?

Typical lead times can range from 8 to 20 weeks, depending on the supplier's current production schedule, order volume, and raw material availability. Custom synthesis or specific purity requirements may extend this period.

Are there any known shortages of TAFENOQUINE SUCCINATE API in the current market?

As of the last market assessment, there are no widespread, documented global shortages of TAFENOQUINE SUCCINATE API. However, localized supply constraints can arise due to specific supplier issues or sudden demand spikes. Continuous market monitoring is advised.

What is the acceptable range for related substances in TAFENOQUINE SUCCINATE API?

Acceptable limits for related substances are defined by pharmacopoeial monographs (e.g., USP, EP) and specific product registration dossiers. Generally, individual unknown impurities are limited to no more than 0.10%, with a total impurity limit typically not exceeding 0.50%. Known impurities will have specific limits assigned.

How can I verify a supplier's GMP compliance independently?

Verification of GMP compliance can be achieved through several methods: requesting Certificates of Analysis (CoAs) for recent batches, reviewing the supplier's regulatory inspection history (e.g., FDA inspection databases), conducting on-site audits of their manufacturing facilities, and requesting a copy of their current GMP certificate.

What is the significance of polymorphic forms for TAFENOQUINE SUCCINATE API?

Polymorphic forms (different crystalline structures) of an API can impact its physical properties, including solubility, dissolution rate, and bioavailability. Ensuring that the API supplied consistently exhibits the desired polymorphic form is critical for the stability and efficacy of the final drug product. Suppliers should be able to characterize and control the polymorphic form.

CITATIONS

[1] U.S. Food and Drug Administration. (n.d.). FDA Inspection Databases. Retrieved from https://www.fda.gov/ (Specific database searches are required) [2] European Medicines Agency. (n.d.). Information on inspections. Retrieved from https://www.ema.europa.eu/ (Specific database searches are required) [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. Retrieved from https://www.ich.org/