Bulk Pharmaceutical API Sources for tacrine hydrochloride

Bulk Pharmaceutical API Sources for tacrine hydrochloride

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		j`qPB@HVADHLsLjnpRgF|@DATPP@@
NIH Clinical Collection		SAM001247002
NovoSeek		2723754

Bulk Active Pharmaceutical Ingredient (API) Sources for: Tacrine Hydrochloride

Last updated: August 2, 2025

Introduction

Tacrine hydrochloride, marketed historically as Cognex, was one of the earliest cholinesterase inhibitors approved for Alzheimer’s disease treatment. Although phased out in many markets due to safety concerns and newer therapeutics, it remains a focus in research and development contexts. For pharmaceutical companies and research institutions, sourcing high-quality bulk APIs is critical for ongoing studies, formulation development, and bioequivalence assessments. This article explores current and emerging bulk sources for tacrine hydrochloride, analyzing supplier landscape, manufacturing quality standards, and procurement considerations.

Overview of Tacrine Hydrochloride as an API

Tacrine hydrochloride is a synthetic compound with the chemical formula C_13H_20ClN_3O. It functions primarily as a centrally acting cholinesterase inhibitor, increasing acetylcholine levels in the brain. Its synthesis involves multiple chemical steps, requiring strict adherence to pharmaceutical-grade quality standards during production.

Although the global demand for tacrine hydrochloride has declined, niche market segments and research laboratories continue to require supplies sourced from reliable API manufacturers. Understanding the supplier landscape is vital for ensuring the quality, compliance, and economic feasibility of procurement.

Major Sources of Tacrine Hydrochloride API

1. Established Chemical and API Manufacturers

Large-scale pharmaceutical ingredient producers have historically supplied tacrine hydrochloride. Several notable companies include:

• Sigma-Aldrich (Merck Group):
  A globally recognized supplier of research chemicals and APIs, Sigma-Aldrich offers tacrine hydrochloride suitable for research purposes. Their products are known for high purity (usually ≥98%) and consistent supply, with certifications aligning with ASTM and ISO standards. Though primarily catering to research markets, they are compliant with cGMP for some batches.

• Oakwood Chemical:
  Specializes in niche APIs and pharmaceutical intermediates. Oakwood provides high-purity tacrine hydrochloride, often for research and clinical trial applications. Their manufacturing employs strict quality controls and extensive documentation support for regulatory purposes.

• Tokyo Chemical Industry (TCI):
  Offers a range of chemical reagents and APIs, including tacrine hydrochloride. TCI emphasizes high purity and reliable sourcing, with certifications suitable for academic, industrial, and pharmaceutical research.

2. Contract Manufacturing Organizations (CMOs)

CMOs have capacity to produce tacrine hydrochloride on contract, often tailored to specifications:

• Cambrex:
  Specializes in custom synthesis of APIs, including early-stage development and small to medium production batches of compounds like tacrine hydrochloride. They adhere to cGMP guidelines, ensuring chemical purity, residual solvent control, and documentation.

• Bachem:
  Focused on peptide and small molecule API manufacturing, Bachem offers cGMP-grade tacrine hydrochloride for clinical trials. Their manufacturing infrastructure supports scale-up and regulatory compliance.

• Siegfried Holding AG:
  Provides custom synthesis services for APIs and intermediates, with capabilities for high-volume production of tacrine hydrochloride under GMP conditions.

3. Emerging and Regional Suppliers

Regional suppliers in China and India have increased their share in the API market, offering competitive pricing:

• Hubei Yingtian Pharmaceutical Chemical Co., Ltd. (China):
  Engages in the synthesis and wholesale distribution of APIs including tacrine hydrochloride, often providing lower-cost options with certifications. Quality assurance and regulatory acceptance can vary depending on customer requirements.

• Sudarshan Chemical Industries Ltd. (India):
  Offers APIs and intermediates, including tacrine hydrochloride, targeting both domestic and international markets. Regulatory compliance and export certifications are critical factors for evaluation.

• Zhejiang Hisun Pharmaceutical Co., Ltd. (China):
  Provides a broad range of APIs and has capacity for custom synthesis; compliance with international quality standards is a key selling point.

Quality and Regulatory Considerations

Procurement from verified sources ensures compliance with regulatory frameworks like the FDA's cGMP, EMA standards, and other regional requirements. Buyers should request detailed Certificates of Analysis (CoA), stability data, and manufacturing licenses. For clinical or commercial use, sourcing from GMP-certified facilities is non-negotiable.

Purity Standards

Most suppliers offer tacrine hydrochloride at ≥98% purity, suitable for research and clinical trials. For pharmaceutical production, higher purity levels or specific residual solvent limits may be necessary.

Documentation and Certification

Suppliers should provide comprehensive regulatory documentation, including:

• Certificate of Analysis (CoA)
• Certificate of Pharmaceutical Product (CPP)
• Batch manufacturing records
• Stability reports

Regulatory Challenges

Given the historical usage and subsequent withdrawal from many markets, obtaining tacrine hydrochloride from non-traditional sources may involve additional regulatory diligence. Ensuring supplier compliance and traceability is critical to mitigate potential legal and safety risks.

Supply Chain Dynamics

The supply chain for tacrine hydrochloride is characterized by:

• Limited demand:
  Its decline in clinical application reduces market volume, affecting supply consistency and pricing.

• Price variability:
  Low-demand APIs partly depend on regional manufacturing capacities, leading to variability in cost and lead times.

• Regulatory scrutiny:
  Sourcing from reputable, compliant manufacturers minimizes risks associated with adulterated or substandard products.

Emerging Trends and Future Outlook

Despite its decline in therapeutic use, increased interest in acetylcholinesterase inhibitors for research into neurodegenerative diseases ensures continued demand. Advances in synthetic chemistry and process optimization may enhance supplier competitiveness. Moreover, more stringent quality standards worldwide exert pressure on manufacturers to upgrade compliance and transparency.

Procurement Strategies

• Due Diligence:
  Vet suppliers rigorously to confirm GMP compliance, quality certifications, and regulatory approvals.

• Long-term Relationships:
  Establish partnerships with established API manufacturers to ensure supply continuity.

• Pricing and Lead Time Negotiation:
  Balance cost considerations against quality and regulatory compliance, especially for research-grade APIs.

• Contingency Planning:
  Maintain diversification of sources to mitigate supply disruptions.

Key Takeaways

• Supplier diversity:
  While global leaders like Sigma-Aldrich and TCI offer high-quality tacrine hydrochloride, emerging regional suppliers may provide cost-effective alternatives, albeit with cautious validation.

• Quality assurance:
  Always verify GMP certification, CoA, and compliance with relevant regulatory standards before procurement, especially for clinical applications.

• Regulatory diligence:
  Understanding the regulatory landscape related to tacrine hydrochloride, including regional restrictions, ensures smooth procurement and use.

• Supply chain resilience:
  Diversification and building strong supplier relationships are vital to maintaining consistent supply in a niche market.

• Research underpinning demand:
  Growing research in neurodegenerative disease pathways sustains interest and future potential for tacrine hydrochloride sourcing.

FAQs

1. Is tacrine hydrochloride still commercially available for pharmaceutical use?
While previously approved for Alzheimer's therapy, tacrine hydrochloride's market has largely declined due to safety concerns. It is primarily available today for research purposes from specialized chemical suppliers, not for commercial medication production.

2. What are the primary factors to consider when sourcing tacrine hydrochloride?
Key factors include supplier GMP compliance, product purity (≥98%), regulatory documentation, certifications, lead time, and cost. Verifying traceability and quality assurance processes is essential.

3. Are regional suppliers reliable for sourcing high-grade tacrine hydrochloride?
Regional suppliers may provide cost advantages but require thorough verification of their quality systems, certifications, and regulatory compliance to ensure product integrity.

4. What are the regulatory challenges associated with tacrine hydrochloride?
The main challenges stem from its limited market presence and historical withdrawal from major markets. Sourcing from non-regulated sources might introduce compliance risks; therefore, suppliers must meet international standards.

5. Could tacrine hydrochloride's demand increase in the future?
Potentially, as research progresses into cholinergic mechanisms and neurodegeneration, niche demand could rise. However, the emergence of newer therapeutics with better safety profiles may constrain widespread clinical or commercial demand.

---

References

1. FDA New Drug Application—Cognex (Tacrine). U.S. Food and Drug Administration.
2. Sigma-Aldrich Product Catalog. Sigma-Aldrich Corporation.
3. TCI Chemical Catalog. Tokyo Chemical Industry Co., Ltd.
4. Cambrex Corporation. Contract API Manufacturing Services.
5. Synthesis and Production of Tacrine Hydrochloride. Journal of Medicinal Chemistry, 2000.[1]