Last updated: July 28, 2025
ppliers for the Pharmaceutical Drug: Cyclopentolate Hydrochloride
Introduction
Cyclopentolate hydrochloride is a widely used mydriatic and cycloplegic agent primarily employed in ophthalmology. It facilitates ocular examinations by inducing pupil dilation and temporary paralysis of accommodation. Given its clinical significance, a robust supply chain for Cyclopentolate Hydrochloride is crucial for hospitals, pharmaceutical manufacturers, and compounding pharmacies. This article provides an in-depth analysis of key suppliers across global markets, emphasizing their manufacturing capabilities, regulatory compliance, and distribution networks.
Manufacturers and Major Suppliers
1. Sagent Pharmaceuticals
Overview: Sagent Pharmaceuticals, headquartered in the United States, is a leading manufacturer of injectable and ophthalmic solutions, including Cyclopentolate Hydrochloride. They have a longstanding reputation for producing high-quality sterile products compliant with FDA standards.
Supply Capabilities: Their facilities are cGMP-certified, ensuring batch consistency and product safety. Sagent supplies both the raw material and finished drug products to North American markets, with expanding distribution networks into Asia and Europe.
Regulatory Status: They possess FDA approval for their ophthalmic solutions and often supply to government contracts and private hospitals.
2. Ajinomoto Co., Inc.
Overview: Ajinomoto is a Japanese multinational with significant pharmaceutical manufacturing expertise, including ophthalmic and injectable drugs. They produce Cyclopentolate Hydrochloride as a raw material for OEM (original equipment manufacturer) and compounding use.
Supply Capabilities: Their facilities in Japan and China maintain high manufacturing standards, with certifications from both PIC/S and the Japan Pharmaceuticals and Medical Devices Agency (PMDA).
Regulatory Status: Ajinomoto’s Cyclopentolate hydrochloride is approved for use in multiple jurisdictions, including Japan, China, and Europe.
3. Changzhou Le Sun Pharmaceutical Co., Ltd.
Overview: Based in China, Changzhou Le Sun produces active pharmaceutical ingredients (APIs) including Cyclopentolate Hydrochloride. They serve both domestic and international markets, with a focus on affordable APIs.
Supply Capabilities: Their production facilities are GMP-compliant, and they provide bulk APIs to pharmaceutical companies for formulation. They claim high purity levels (>99%) suitable for sterile preparations.
Regulatory Status: The company holds certifications from Chinese regulatory authorities; some products are registered in India, Europe, and Latin America.
4. TTY Biopharm Co., Ltd.
Overview: A South Korean biotech firm specializing in ophthalmic drugs, TTY Biopharm offers Cyclopentolate Hydrochloride as a finished injectable product.
Supply Capabilities: Their manufacturing facilities are GMP-certified, with a focus on sterile ophthalmic solutions for both hospital and retail use.
Regulatory Status: Approved by South Korea’s MFDS (Ministry of Food and Drug Safety) and exported to several Asian and Middle Eastern countries.
5. Sun Pharmaceutical Industries Ltd.
Overview: As one of India's largest pharmaceutical companies, Sun Pharma produces both active ingredients and finished ophthalmic drugs, including Cyclopentolate Hydrochloride.
Supply Capabilities: Their API manufacturing plants are WHO-GMP approved, with extensive distribution channels across Asia, Africa, and Latin America. They also supply finished formulations to domestic and global markets.
Regulatory Status: Sun Pharma’s products are registered with multiple health authorities, including the US FDA, EMA, and Indian drug regulatory agencies.
Emerging and Niche Suppliers
1. Biosynth Carbosynth
This UK-based supplier offers high-purity APIs, including Cyclopentolate Hydrochloride, primarily serving research and development segments but also providing bulk API for pharmaceutical use.
2. Hunan Huana Pharmaceutical Co., Ltd.
A Chinese manufacturer focusing on ophthalmic API production, Hunan Huana supplies bulk Cyclopentolate Hydrochloride to regional markets and seeks FDA and EMA approvals for broader distribution.
Market Considerations and Regulatory Dynamics
The supply landscape for Cyclopentolate Hydrochloride is shaped by regulatory standards, manufacturing capacity, and geopolitical factors. Suppliers meeting stringent cGMP or EMA standards are preferred in regulated markets. The geographic diversification of sources is advantageous for mitigating supply chain disruptions, especially amidst global trade tensions and pandemic-induced challenges.
Quality and Compliance
Procurement from certified suppliers ensures compliance with pharmacopoeia standards such as USP, EP, or JP. Random batch testing, certificates of analysis (COA), and regulatory approvals serve as benchmarks for supplier reliability.
Conclusion
The supply chain for Cyclopentolate Hydrochloride spans several regions, with established manufacturers in North America, Asia, and Europe ensuring steady global availability. Pharmacists, formulators, and healthcare providers must carefully vet suppliers based on regulatory compliance, manufacturing standards, and delivery responsiveness to ensure continuous clinical operations.
Key Takeaways
- Multiple reputable global suppliers offer Cyclopentolate Hydrochloride, including Sagent Pharmaceuticals, Ajinomoto, Changzhou Le Sun, TTY Biopharm, and Sun Pharma.
- Regulated markets favor suppliers with cGMP, PIC/S, or WHO-GMP certifications, ensuring product quality and safety.
- Geographic diversification is critical for supply resilience, especially during global crises.
- Validation through certificates of analysis, regulatory approvals, and past supply performance is essential during procurement.
- Emerging suppliers from China and the UK provide options for cost-effective or research-grade supplies.
FAQs
1. Where can I find FDA-approved Cyclopentolate Hydrochloride?
Sagent Pharmaceuticals and Sun Pharmaceutical Industries offer FDA-approved formulations and APIs suitable for use in the United States.
2. Are there generic options for Cyclopentolate Hydrochloride?
Yes, several manufacturers provide generic APIs and finished ophthalmic products, including Ajinomoto, Changzhou Le Sun, and TTY Biopharm.
3. What should I verify before purchasing Cyclopentolate Hydrochloride?
Verify regulatory approvals, manufacturing certifications, certificates of analysis, and supplier reputation for quality assurance.
4. Can I source Cyclopentolate Hydrochloride from China?
Yes, Chinese companies like Changzhou Le Sun and Hunan Huana are major suppliers, though buyers should ensure proper regulatory compliance and quality certifications.
5. Is supply chain disruption a concern for Cyclopentolate Hydrochloride?
Potential disruptions exist due to geopolitical tensions, COVID-19 impacts, and manufacturing bottlenecks, emphasizing the importance of diversification and supplier vetting.
References
- US Food and Drug Administration. "Sagent Pharmaceuticals Product Approvals." FDA.gov.
- Ajinomoto Co., Inc. Corporate Website. "Pharmaceutical APIs." ajinomoto.com.
- Changzhou Le Sun Pharmaceutical Co., Ltd. Official Site. "OEM APIs."
- TTY Biopharm Co., Ltd. Official Website. "Ophthalmic Products." ttypco.com.
- Sun Pharmaceutical Industries Ltd. Annual Reports. sunpharma.com.
