DAPIPRAZOLE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baradaina Llc	DAPIPRAZOLE HYDROCHLORIDE	dapiprazole hydrochloride	SOLUTION/DROPS;OPHTHALMIC	204902	ANDA	Baradaina, LLC	53020-265-01	1 KIT in 1 CARTON (53020-265-01) * 5 mL in 1 VIAL (53020-255-01) * 5 mL in 1 VIAL (53020-245-01)	2019-07-31
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 2, 2025

Introduction

Dapiprazole hydrochloride is a selective alpha-adrenergic antagonist historically used in ophthalmology as a mydriatic agent to reverse pupillary dilation caused by sympathomimetic drugs. Although its clinical use has diminished with the advent of alternative agents, dapiprazole remains relevant in pharmaceutical research, specialty formulations, and as a reference compound in drug development pipelines. Consequently, identifying reliable suppliers for dapiprazole hydrochloride is vital for pharmaceutical companies, research institutions, and compounding pharmacies.

This article investigates the current landscape of dapiprazole hydrochloride suppliers, outlining their capabilities, regulatory compliance, supply chain stability, and competitive positioning. The analysis underscores factors that influence supplier selection, including purity standards, certification, delivery timelines, and geographic reach.

Market Overview and Regulatory Context

Dapiprazole hydrochloride is not a blockbuster pharmaceutical agent; its market is niche, primarily driven by research needs and specialized ophthalmic applications. The pharmaceutical supply chain for such compounds often involves chemical manufacturers, custom synthesis providers, and authorized distributors adhering to stringent quality standards.

Regulatory compliance with Good Manufacturing Practice (GMP) standards, ISO certifications, and adherence to international pharmacopoeia specifications (e.g., USP, EP) are critical for suppliers, especially when the compound transitions from research to clinical applications or formulation processes.

Major Suppliers of Dapiprazole Hydrochloride

1. Toronto Research Chemicals (TRC)

Overview: TRC provides a broad spectrum of research chemicals, including pharmacologically active compounds, with a focus on high purity and reliable supply.
Capabilities: Their dapiprazole hydrochloride is supplied in various quantities suitable for laboratory research, with purity exceeding 98% as verified by their Certificates of Analysis (CoA).
Certifications: ISO 9001 certification and adherence to quality control protocols.
Application: Mainly research-focused, suitable for pharmacological studies and preclinical testing.

2. Tocris Bioscience (A part of Bio-Techne)

Overview: Tocris specializes in biochemicals and pharmacological tools for biomedical research.
Product Details: Offers dapiprazole hydrochloride in powder form, complying with high purity standards (≥98%).
Strengths: Robust distribution network, global reach, and comprehensive technical support.
Compliance: Meets industry standards, though primarily for research use; not typical for GMP manufacturing.

3. Sigma-Aldrich (Merck KGaA)

Overview: A global leader in research chemicals, Sigma-Aldrich supplies a variety of pharmacological agents, including dapiprazole hydrochloride.
Product Features: Purity levels typically ≥98%, with detailed CoAs and regulatory compliance documentation.
Application: Mostly utilized in research, with some batches possibly suitable for investigational medicinal products pending further validation.

4. Toronto Research Chemicals (TRC) – Custom Synthesis and Specialty Solutions

Additional Capabilities: TRC offers custom synthesis options for dapiprazole hydrochloride and analogs, catering to unique research or formulation requirements.
Advantages: Flexibility in quantity, purity, and form.

5. Chinese Chemical Manufacturers and Distributors

Emerging Suppliers: Several Chinese suppliers have entered the market offering dapiprazole hydrochloride at competitive prices.
Considerations: Variability in quality control, product documentation, and regulatory compliance necessitates rigorous qualification processes.
Due Diligence: Suppliers should be evaluated based on their GMP certifications, CoAs, and inspection reports.

Niche and Specialty Suppliers

While the mainstream chemical suppliers dominate, niche providers focusing on ophthalmic research chemicals sometimes act as intermediaries. These entities may source dapiprazole hydrochloride from primary manufacturers and offer tailored distribution channels. Examples include:

Adamag Pharmaceuticals
Alfa Aesar (a Johnson Matthey company)

Though less common, they serve specific customer segments requiring tailored packaging, stability studies, or unique formulations.

Factors Influencing Supplier Selection

Regulatory Compliance:
Selecting suppliers with GMP or equivalent certifications reduces regulatory risks, especially when transitioning compounds into clinical pipelines or commercial formulations.

Product Purity & Specification:
High purity (>98%) ensures reliability in research and minimizes confounding variables.

Supply Chain Stability:
Reliability in delivery schedules and inventory management prevents delays, essential for ongoing R&D projects.

Pricing & MOQ:
Given the niche market, pricing varies; bulk purchase agreements may offer cost advantages.

Technical Support & Documentation:
Comprehensive CoAs, safety data sheets (SDS), and technical data sheets facilitate regulatory filings and quality assurance.

Geographic Reach & Logistics:
Global suppliers with efficient logistics networks ensure timely supply across regions.

Challenges in the Supply Landscape

Market Size Constraints: Limited commercial demand constrains manufacturers' incentives to produce at scale, affecting availability and price.
Regulatory Variability: Suppliers in different regions may have inconsistent documentation or certification levels.
Research-Use-Only (RUO) Restrictions: Many suppliers categorize dapiprazole hydrochloride as RUO, limiting its use in clinical formulations without further validation.

Future Outlook and Opportunities

The demand for dapiprazole hydrochloride remains niche but persists in academic and pharmaceutical research. Opportunities include:

Expanding GMP-grade offerings to meet clinical development needs.
Developing novel formulations leveraging dapiprazole’s pharmacological profile.
Establishing strategic partnerships with primary chemical manufacturers in Asia for quality-assured supply.

Emphasizing quality assurance and regulatory compliance will be critical for suppliers seeking to expand into clinical development markets.

Key Takeaways

Leading suppliers such as Toronto Research Chemicals, Tocris Bioscience, and Sigma-Aldrich provide high-purity dapiprazole hydrochloride primarily for research applications.
Quality assurance, including GMP certification and comprehensive documentation, remains paramount when choosing a supplier.
Emerging Chinese manufacturers offer competitive pricing but require thorough qualification due to regulatory variability.
Industry trends point toward increased demand for GMP-grade dapiprazole to facilitate clinical trials and potential commercial development.
Supply chain stability and technical support are critical considerations in ensuring seamless research and development processes.

FAQs

1. Is dapiprazole hydrochloride available in GMP-grade from commercial suppliers?
Current availability of GMP-grade dapiprazole hydrochloride is limited. Most suppliers provide research-grade material, but some, such as specialized chemical manufacturers, are developing GMP-compliant versions for clinical use.

2. Can dapiprazole hydrochloride be used for clinical formulations?
While historically used in ophthalmic research, dapiprazole's clinical use is limited. Transitioning into clinical formulations requires GMP-grade material and extensive safety and stability testing.

3. What should I verify before purchasing dapiprazole hydrochloride?
Ensure the supplier provides Certificates of Analysis, demonstrates compliance with relevant quality standards, specifies purity levels (preferably ≥98%), and offers traceability documentation.

4. Are there regional restrictions on dapiprazole hydrochloride?
Regulatory controls vary by country. It is classified as a research chemical in many jurisdictions, with stricter controls in some regions for clinical use.

5. What are the typical pricing considerations for dapiprazole hydrochloride?
Pricing depends on purity, quantity, supplier origin, and certification standards. Bulk orders generally reduce unit costs but require larger upfront investments.

Conclusion

Selecting an appropriate supplier for dapiprazole hydrochloride requires balancing quality, regulatory compliance, supply reliability, and cost. Established global research chemical providers dominate the market, with emerging regional manufacturers offering competitive options. Businesses aiming to incorporate dapiprazole into clinical applications must prioritize GMP compliance and detailed documentation, supported by a robust qualification process. Continual market developments point toward increasing availability of GMP-grade material, aligning with evolving pharmaceutical development demands.

References

[1] Toronto Research Chemicals. (2023). Dapiprazole Hydrochloride Product Details.
[2] Bio-Techne/Tocris. (2023). Dapiprazole Hydrochloride, Technical Datasheet.
[3] Sigma-Aldrich. (2023). Dapiprazole Hydrochloride Specifications and Safety Data.
[4] World Health Organization. (2022). Good Manufacturing Practices for Pharmaceuticals.
[5] U.S. FDA. (2021). Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations.

Suppliers and packagers for generic pharmaceutical drug: DAPIPRAZOLE HYDROCHLORIDE