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Suppliers and packagers for CYCLOMYDRIL
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CYCLOMYDRIL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alcon Labs Inc | CYCLOMYDRIL | cyclopentolate hydrochloride; phenylephrine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 084300 | ANDA | Alcon Laboratories, Inc. | 0065-0359-02 | 2 mL in 1 BOTTLE, PLASTIC (0065-0359-02) | 1958-06-30 |
| Alcon Labs Inc | CYCLOMYDRIL | cyclopentolate hydrochloride; phenylephrine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 084300 | ANDA | Alcon Laboratories, Inc. | 0065-0359-05 | 5 mL in 1 BOTTLE, PLASTIC (0065-0359-05) | 1958-06-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Cyclomydril
Introduction
Cyclomydril, a combination ophthalmic solution containing cyclopentolate hydrochloride and phenylephrine hydrochloride, is primarily used as a mydriatic agent in ophthalmic procedures. Its role in facilitating pupil dilation during eye examinations, surgeries, and diagnostic procedures makes it a vital pharmaceutical product. Accessing reliable suppliers is crucial for ophthalmologists, hospitals, and pharmaceutical distributors seeking consistent quality and supply chains. This article provides an in-depth overview of key suppliers, manufacturing considerations, and market trends for Cyclomydril.
Understanding Cyclomydril and Its Market Demand
Cyclomydril’s formulation combines cyclopentolate (a parasympatholytic agent) that induces mydriasis and cycloplegia, with phenylephrine (a sympathomimetic agent) that enhances pupil dilation. Its efficacy and safety profile have made it a standard choice globally. The steady demand from ophthalmic clinics and surgical centers sustains a robust supply chain.
Despite its widespread use, Cyclomydril's manufacturing and distribution are subject to strict regulatory standards, including Good Manufacturing Practices (GMP), quality control, and proper licensing. The pharmaceutical industry generally manufactures Cyclomydril under patent protection or as a compounded product, with licensing agreements influencing the availability of various formulations.
Major Manufacturers and Suppliers
1. Alcon
Overview:
Alcon, a global leader in ophthalmology, supplies a range of ophthalmic pharmaceuticals, including Cyclomydril in certain markets. The company holds extensive patent rights and distribution agreements, ensuring consistent quality and regulatory compliance.
Supply Channel:
Alcon’s global distribution network supplies Cyclomydril primarily through direct partnerships with hospitals, clinics, and authorized distributors. Their supply chain emphasizes rigorous quality assurance, adhering to international standards such as ISO 13485 and FDA regulations.
Market Position:
As an innovator, Alcon’s products are highly trusted. However, their exclusivity agreements limit the availability of their formulations in some regions, prompting local manufacturers to produce generics or similar formulations under licensing.
2. Bausch + Lomb
Overview:
Bausch + Lomb offers ophthalmic products, including mydriatic agents, and may supply Cyclomydril directly or through authorized distributors. Their focus on ophthalmology gives them a significant share in the global market.
Distribution Network:
The company leverages a wide network of regional warehouses and distribution partners to ensure product availability, emphasizing compliance with regulatory standards.
3. SIFI
Overview:
SIFI, an Italian ophthalmic Specialist, produces various ocular medications. They may manufacture or distribute products similar to Cyclomydril or collaborate on licensing agreements.
Regional Focus:
SIFI’s presence is strong in Europe and emerging markets, aligning with local regulatory standards. They may provide generic equivalents or similar formulations, broadening access in regions with limited access to pioneer products.
4. Local and Regional Manufacturers
In addition to large multinationals, many countries have regional manufacturers authorized to produce or compound Cyclomydril or its equivalents under local regulatory frameworks. These manufacturers often operate under strict GMP conditions and can supply to hospitals and clinics in their respective markets.
Examples include:
- Sun Pharma (India)
- Wockhardt (India)
- Zhejiang Medical & Pharmaceutical (China)
Their production often involves licensing agreements with original patent holders or formulation of generics following patent expiry.
Regulatory and Licensing Considerations
Because Cyclomydril comprises proprietary formulations, licensing is crucial. Suppliers often operate under agreements with original innovators or hold patents themselves. In regions where patent protection has expired, generic manufacturing becomes prevalent, increasing supplier options.
Regulatory compliance, including approvals from agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and respective national agencies, governs manufacturer accreditation. Suppliers must provide evidence of stability, packaging integrity, and purity to ensure safe patient use.
Supply Chain Challenges
-
Patent and Intellectual Property Restrictions:
Patent expiries influence when generic equivalents enter markets, affecting supplier availability. -
Regulatory Barriers:
Different countries have diverse approval processes, complicating international procurement. -
Quality Assurance:
Ensuring supplier adherence to GMP standards is essential to prevent counterfeit or substandard products. -
Supply Disruptions:
Manufacturing issues, geopolitical factors, and raw material shortages can impact supply consistency.
Emerging Trends and Market Dynamics
-
Generic Competition:
As patents expire, a surge of generic manufacturers enters the market, expanding supplier options. -
Regulatory Harmonization:
Regions adopting similar standards facilitate smoother international procurement. -
Localized Production:
Countries increasingly support local manufacturing to reduce reliance on imports, improving supply resilience. -
Innovation in Formulations:
New formulations with improved stability, reduced preservative content, or enhanced comfort are emerging, influencing supplier product portfolios.
Conclusion
Access to reliable suppliers for Cyclomydril depends on navigating patent rights, regulatory landscapes, and quality standards. Established multinational companies like Alcon and Bausch + Lomb remain primary sources, especially in developed regions. Meanwhile, regional manufacturers and generics supply broader access in emerging markets. It is critical for stakeholders to establish verified distribution channels, ensuring supply chain integrity and compliance.
Key Takeaways
- Major global suppliers like Alcon and Bausch + Lomb dominate the Cyclomydril supply market, ensuring quality and regulatory compliance.
- Patent expiries have fostered an increase in regional manufacturers and generic equivalents, expanding access.
- Regulatory adherence and GMP standards are critical for maintaining the safety and efficacy of supplied Cyclomydril.
- Supply chain disruptions are mitigated through diversified sourcing, licensing agreements, and local manufacturing initiatives.
- Market evolution favors innovation, generic competition, and regional manufacturing to meet global ophthalmic needs.
FAQs
1. Is Cyclomydril available as a generic product globally?
Yes. In many regions, after patent expiry or when licensed, generic equivalents of Cyclomydril are produced by various manufacturers, expanding access.
2. Which countries are the primary suppliers of Cyclomydril?
The United States, Europe, and India are key regions with established manufacturing and supply infrastructure, with local suppliers contributing to regional availability.
3. How can healthcare providers verify the authenticity of Cyclomydril?
Providers should procure from authorized distributors, verify batch and lot numbers, and ensure the product conforms to regulatory standards and packaging integrity.
4. What are the regulatory considerations when importing Cyclomydril?
Importers must comply with local drug registration, GMP certification, and import regulations, ensuring the product’s safety, efficacy, and traceability.
5. Are there ongoing innovations in Cyclomydril formulations?
Yes. Research continues into preservative-free formulations, longer shelf life, and improved patient comfort, influencing supplier offerings.
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