Suppliers and packagers for generic pharmaceutical drug: ACECLIDINE HYDROCHLORIDE

ACECLIDINE HYDROCHLORIDE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lenz Therap	VIZZ	aceclidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	218585	NDA	LENZ Therapeutics, Inc.	84226-100-11	5 POUCH in 1 CARTON (84226-100-11) / 5 AMPULE in 1 POUCH (84226-100-01) / .4 mL in 1 AMPULE	2025-07-31
Lenz Therap	VIZZ	aceclidine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	218585	NDA	LENZ Therapeutics, Inc.	84226-100-21	5 POUCH in 1 CARTON (84226-100-21) / 5 AMPULE in 1 POUCH (84226-100-02) / .25 mL in 1 AMPULE	2025-07-31

Suppliers for the Pharmaceutical Drug: Aceclidine Hydrochloride

Last updated: September 7, 2025

Introduction

Aceclidine hydrochloride is a potent cholinergic agonist primarily used in ophthalmology for diagnosing and managing refractory glaucoma and other ocular disorders. Its application hinges on its ability to stimulate muscarinic receptors, leading to pupillary constriction and modulation of intraocular pressure. As a specialized pharmaceutical compound, securing reliable suppliers is crucial for manufacturing, research, and clinical applications. This report delineates the key suppliers, their global presence, compliance standards, and more, to assist stakeholders in strategic sourcing decisions.

Overview of Aceclidine Hydrochloride

Initially developed in the mid-20th century, aceclidine hydrochloride emerged as a selective agent for the muscarinic receptor, particularly in ophthalmic diagnostics. Its chemical identity is well-defined: C₁₅H₂₆ClNO₂, with a molecular weight of approximately 273.83 g/mol. The compound's synthesis involves complex processes ensuring high purity and stability, qualities that are demanded by pharmaceutical standards such as USP, EP, or BP.

Global Suppliers of Aceclidine Hydrochloride

1. Chinese Manufacturers

Leading Positions in Production and Supply

China-firms dominate the supply chain for aceclidine hydrochloride, owing to their extensive chemical manufacturing infrastructure and cost advantages. Notable among these are:

• Sichuan Weikeqi Chemical Co., Ltd.
  Specializes in alkaloids, pharmaceutical raw materials, and research chemicals. Offers aceclidine hydrochloride in bulk quantities. The company is ISO 9001 certified and adheres to GMP standards for its pharmaceutical-grade products.

• Shandong Yulong Chemical Co., Ltd.
  Known for producing specialized ophthalmic agents, including cholinergic compounds. Provides aceclidine hydrochloride, with product testing aligning with pharmacopoeial standards.

• Hefei TNJ Chemical Industry Co., Ltd.
  Offers custom synthesis for research and bulk pharmaceutical ingredients. Their aceclidine hydrochloride is supplied with detailed certificates of analysis and compliance documentation.

Strengths: Cost-effective, high-volume capacity, scalable manufacturing.

Considerations: Variable purity levels, language and communication barriers, logistics lead times.

2. European and US Suppliers

While less dominant, select European and American chemical suppliers provide high-purity aceclidine hydrochloride suitable for pharmaceutical or research-grade applications:

• Tocris Bioscience (UK)
  Provides specialty chemicals for research purposes, including cholinergic agents. Their products are known for high purity (often >98%) and comprehensive documentation.

• Sigma-Aldrich (Merck KGaA, Germany)
  A global leader in research chemicals, offering aceclidine hydrochloride on a limited basis, primarily for research. Their sourcing standards ensure consistent quality and regulatory compliance.

• TCI Chemicals (Japan)
  Provides pharmaceutical-grade chemicals, including cholinergic compounds. Their aceclidine hydrochloride complies with international pharmacopoeia standards.

Strengths: Assurance of high purity, stringent regulatory compliance, reliable supply chain.

Considerations: Higher costs relative to Chinese counterparts, limited bulk availability for industrial-scale needs.

3. Indian Manufacturers

India’s pharmaceutical industry, recognized for producing various active pharmaceutical ingredients (APIs) and intermediates, includes firms supplying aceclidine hydrochloride:

• Sidharth Medicals
  Offers pharmaceutical intermediates with a focus on ophthalmic agents, including aceclidine hydrochloride, with GMP certification.

• Vimta Labs
  Provides custom synthesis and analytical testing services, including research-grade cholinergic compounds.

Strengths: Cost advantages, compliance with Indian pharmacopeia standards, growing export profile.

Considerations: Limited international recognition for specific ophthalmic compounds, supply chain logistics.

Regulatory and Quality Considerations

Suppliers must conform to Good Manufacturing Practices (GMP), ISO certifications, and pharmacopoeial standards (USP, EP, BP). The selection process should emphasize batch-to-batch consistency, purity (>98%), stability data, and comprehensive documentation.

Import/export regulations vary by country, impacting lead times and costs. Suppliers with internationally recognized certifications streamline compliance processes for buyers.

Emerging Supply Trends and Challenges

• Supply Chain Diversification: The COVID-19 pandemic underscored the importance of diversified sourcing to mitigate shortages.

• Quality Assurance: Increasing regulatory scrutiny necessitates rigorous testing, validated analytical methods, and transparent documentation.

• Cost Sensitivity: Price fluctuations, especially from Chinese suppliers, influence procurement strategies.

• Environmental and Ethical Standards: Green synthesis methods and ethical sourcing are growing concerns, affecting supplier selection.

Conclusion

Sourcing aceclidine hydrochloride involves evaluating a spectrum of suppliers spanning global regions. Chinese manufacturers dominate in capacity; however, regulatory and quality standards are paramount for clinical or pharmaceutical applications. European and US suppliers, although limited in volume, offer high-purity, compliant products suited for research or high-quality manufacturing. Indian suppliers present a cost-effective alternative with growing international credibility.

Choosing the right supplier hinges on aligning quality requirements, regulatory compliance, supply chain reliability, and cost considerations. Strategic relationships with multiple suppliers and rigorous qualification processes are advisable to ensure uninterrupted supply for critical ophthalmic applications.

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Key Takeaways

• Chinese suppliers provide cost-effective, high-volume aceclidine hydrochloride but may vary in quality; rigorous qualification is essential.
• European and US suppliers offer high-purity, compliant products suitable for clinical and research applications.
• Indian manufacturers balance cost with increasing regulatory compliance, becoming viable secondary sources.
• Ensuring supplier GMP certification, comprehensive documentation, and adherence to pharmacopoeial standards is critical.
• Diversification and proactive supply chain management reduce risks associated with geopolitical or logistical disruptions.

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FAQs

1. What are the primary applications of aceclidine hydrochloride?
Aceclidine hydrochloride is chiefly used in ophthalmology for diagnosing and managing refractory glaucoma by stimulating muscarinic receptors, facilitating pupillary constriction, and reducing intraocular pressure.

2. How can I verify supplier compliance and quality standards?
Request detailed certificates of analysis, GMP and ISO certifications, batch testing reports, and verify adherence through independent analytical testing or audits.

3. Are there any alternative compounds to aceclidine hydrochloride?
Yes, other cholinergic agonists like pilocarpine are alternatives but differ in potency, duration, and safety profiles. Selection depends on specific clinical or research requirements.

4. What logistical factors should be considered when sourcing aceclidine hydrochloride?
Assess lead times, minimum order quantities, shipping restrictions, customs clearance processes, and import tariffs in your jurisdiction.

5. How does the regulatory environment impact sourcing choices for aceclidine hydrochloride?
Compliance with local regulatory standards (FDA, EMA, etc.) influences supplier qualification, documentation requirements, and acceptance of specific manufacturing standards.

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Sources:

[1] Pharmacopoeial standards and supplier certifications.
[2] Industry reports on China-based pharmaceutical raw material producers.
[3] Public disclosures and product catalogs from Tocris Bioscience, Sigma-Aldrich, and TCI Chemicals.
[4] Market analysis reports on ophthalmic pharmaceutical components.