Bulk Pharmaceutical API Sources for CYCLOPENTOLATE HYDROCHLORIDE

Bulk Pharmaceutical API Sources for CYCLOPENTOLATE HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-666-151
AKos Consulting & Solutions		AKOS015901379
Finetech Industry Limited		FT-0603161

Bulk Active Pharmaceutical Ingredient (API) Sources for: CYCLOPENTOLATE HYDROCHLORIDE

Last updated: August 1, 2025

Introduction

Cyclopentolate hydrochloride is a potent anticholinergic agent primarily used as a mydriatic and cycloplegic in ophthalmology. It facilitates ocular examinations by dilating the pupil and paralyzing accommodation. As demand for ophthalmic diagnostics and treatments increases, the procurement of high-quality bulk APIs like cyclopentolate hydrochloride becomes pivotal for pharmaceutical manufacturers. Identifying reliable API suppliers ensures product consistency, regulatory compliance, and supply chain resilience. This article evaluates the global landscape of cyclopentololate hydrochloride API sourcing, considering reputable manufacturers, regulatory factors, and supply chains.

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Overview of Cyclopentolate Hydrochloride API

Cyclopentolate hydrochloride, chemically designated as C17H25ClN2O3, is synthesized through target-specific chemical processes involving cyclopentane derivatives and amino alcohol intermediates. The API's quality hinges on factors such as purity (usually >99%), consistent potency, and minimal impurity profiles, all critical for ophthalmological applications. Reliable suppliers must adhere to Good Manufacturing Practices (GMP) and possess rigorous quality assurance (QA) systems to meet international standards like the United States Pharmacopeia (USP), European Pharmacopoeia (EP), or similar.

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Key Global API Manufacturers for Cyclopentololate Hydrochloride

1. United States and North America

While North American production of cyclopentolate hydrochloride API remains limited, several pharmaceutical contract manufacturing organizations (CMOs) and specialized chemical suppliers import and distribute high-grade APIs for domestic use.

• Fischer Chemical Inc. – Based in the USA, this company offers a wide spectrum of pharmaceutical-grade chemicals, including cyclopentolate hydrochloride, either sourced globally or produced internally. They provide APIs compliant with GMP standards.

• Bachem – Although primarily focused on peptides and custom synthesis, Bachem’s extensive network and quality systems allow sourcing or custom synthesis options for ophthalmic APIs. However, their primary offerings do not explicitly list cyclopentolate hydrochloride.

2. Europe

Europe remains a significant hub for pharmaceutical synthesis, with many suppliers offering cyclopentolate hydrochloride API.

• Synergized Pharmachem – An Indian-origin company with European distribution channels; supplies GMP-grade cyclopentolate hydrochloride. They emphasize compliance with Ph. Eur. and USP standards.

• Neuraxpharm – Based in Spain, Neuraxpharm supplies bulk APIs, including ophthalmic agents. They claim strict adherence to GMP and possess requisite certifications.

• CAM Chembio – Located in France, CAM Chembio specializes in specialty chemicals for pharmaceutical and biotech industries, including cyclopentolate hydrochloride, produced under GMP conditions.

3. Asia-Pacific

The Asia-Pacific region dominates in bulk pharmaceutical ingredient manufacturing, driven by cost advantages and expanding capacities.

• Huangshi Jinhao Pharmaceutical Co., Ltd. (China) – A GMP-certified manufacturer producing cyclopentolate hydrochloride API at large scales. They emphasize product purity and regulatory compliance for global markets.

• Qingdao Bilo Biotechnology Co., Ltd. (China) – Offers GMP-grade cyclopentolate hydrochloride as part of their ophthalmic API portfolio. They operate under strict quality systems and provide consistent supply.

• Maga Laboratories (India) – An established Indian API producer with certifications from WHO and cGMP standards. They supply bulk cyclopentolate hydrochloride with high purity levels suitable for ophthalmic formulations.

• Shandong Liansheng Pharmaceutical Co., Ltd. – Focused on ophthalmic APIs, this Chinese company maintains GMP compliance and exports globally.

4. Emerging and Niche Suppliers

• VIFOR Pharma – While primarily a European specialty pharmaceutical company, VIFOR engages in complex chemical synthesis, including ophthalmic agents, and sources certain APIs via licensed manufacturing agreements.

• Aurisco – Based in China, this ingredient supplier offers custom synthesis and has capabilities for high-quality cyclopentolate hydrochloride, with compliance to international standards.

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Regulatory and Quality Considerations

Securing cyclopentolate hydrochloride API involves navigating regulatory landscapes across jurisdictions.

• GMP Compliance – Suppliers must operate under GMP standards, ensuring batch-to-batch consistency, impurity control, and validation protocols compliant with FDA, EMA, or other authorities.

• Certificates of Analysis (CoA) – Buyers should request CoAs verifying identity, purity (>99%), residual solvents, and impurity profiles.

• Regulatory Approvals – Manufacturers with approved drug master files (DMFs) or equivalents facilitate regulatory submissions and market access.

• Certifications and Accreditations – ISO certifications, additional quality standards, and audits influence supplier reliability.

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Supply Chain Dynamics and Risks

Global manufacturing distribution reduces dependency on single-source providers, but risks include geopolitical instability, trade restrictions, or raw material shortages. Pandemic-related disruptions also impact supply continuity.

To mitigate risks, pharmaceutical companies should:

• Diversify Suppliers – Engage multiple reputable sources across regions.

• Establish Long-term Partnerships – Develop relationships with consistent, compliant manufacturers.

• Monitor Regulatory Evolutions – Stay updated on international standards to ensure compliance.

• Implement Quality Audit Programs – Conduct audits and assessments periodically.

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Emerging Trends in API Sourcing

• Synthetic Routes Optimization – Suppliers are investing in greener, more cost-effective synthesis pathways enhancing purity and yield.

• Digital Verification – Digital platforms facilitate real-time tracking, batch tracing, and quality assurance across supply chains.

• Regulatory Harmonization – Cross-regional acceptance of audits and certifications simplifies procurement processes.

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Key Takeaways

• The global API market for cyclopentolate hydrochloride is characterized by a concentrated presence in China, India, and Europe, with North American options being primarily import-based.

• Manufacturers with GMP certification, extensive quality assurance practices, and compliance with international pharmacopoeias are preferred.

• Diversifying sources and conducting rigorous due diligence mitigate supply risks and enhance regulatory confidence.

• Keeping abreast of regulatory changes and technological innovations can optimize procurement strategies.

• Establishing sustainable and compliant supply chains is critical for pharmaceutical companies producing ophthalmic solutions involving cyclopentolate hydrochloride.

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FAQs

1. What are the key quality attributes I should verify in cyclopentolate hydrochloride API?
Ensure purity levels above 99%, validated impurities profiles, consistent batch-to-batch quality, and GMP compliance. Certificates of analysis confirming these parameters are essential.

2. Is cyclopentolate hydrochloride API sourcing regulated globally?
Yes. Regulatory agencies like the FDA, EMA, and WHO mandate strict standards for GMP compliance, quality documentation, and traceability, irrespective of sourcing location.

3. Can I source cyclopentolate hydrochloride API from multiple regions without regulatory hurdles?
While possible, it requires verifying each supplier’s compliance with regional regulatory requirements and maintaining thorough documentation for approval purposes.

4. What are the typical lead times for bulk cyclopentolate hydrochloride API?
Lead times vary depending on supplier capacity, demand volumes, and regulatory approvals but generally range from four to twelve weeks.

5. Are there any specific raw materials or intermediates critical in the synthesis of cyclopentolate hydrochloride?
Yes. Key intermediates include cyclopentane derivatives and amino alcohol compounds. The quality and sourcing of these intermediates influence final API quality.

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References

1. U.S. Pharmacopeia. Cyclopentolate Hydrochloride Monograph. 2022.
2. European Pharmacopoeia. Cyclopentolate Hydrochloride Monograph. 2021.
3. WHO. WHO Good Manufacturing Practices for Pharmaceutical Products. 2019.
4. Pharmaceutical Supplier Websites and Certification Documents (as per cited manufacturers).
5. Industry Reports and Market Analyses on Ophthalmic API Sourcing.