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Suppliers and packagers for mydriacyl
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mydriacyl
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 | MYDRIACYL | tropicamide | SOLUTION/DROPS;OPHTHALMIC | 084306 | ANDA | Alcon Laboratories, Inc. | 0065-0355-03 | 1 BOTTLE in 1 CARTON (0065-0355-03) / 3 mL in 1 BOTTLE | 1959-04-01 |
| Alcon Labs Inc | MYDRIACYL | tropicamide | SOLUTION/DROPS;OPHTHALMIC | 084306 | ANDA | Alcon Laboratories, Inc. | 0998-0355-15 | 1 BOTTLE in 1 CARTON (0998-0355-15) / 15 mL in 1 BOTTLE | 1959-04-01 |
| Alcon Labs Inc | MYDRIACYL | tropicamide | SOLUTION/DROPS;OPHTHALMIC | 084306 | ANDA | Sandoz Inc | 61314-355-01 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-355-01) / 3 mL in 1 BOTTLE, PLASTIC | 2000-06-13 |
| Alcon Labs Inc | MYDRIACYL | tropicamide | SOLUTION/DROPS;OPHTHALMIC | 084306 | ANDA | Sandoz Inc | 61314-355-02 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-355-02) / 15 mL in 1 BOTTLE, PLASTIC | 2000-06-13 |
| Sandoz | MYDRIACYL | tropicamide | SOLUTION/DROPS;OPHTHALMIC | 084305 | ANDA | Sandoz Inc | 61314-354-01 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-354-01) / 15 mL in 1 BOTTLE, PLASTIC | 2000-06-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: MYDRIACYL
Introduction
Mydriacyl, a well-known pharmaceutical proprietary name for tropicamide, is an ophthalmic agent predominantly used to induce mydriasis (pupil dilation) and cycloplegia (paralysis of the ciliary muscle). Approved for diagnostic purposes and ocular surgery, its global demand hinges on a consistent supply chain comprising multiple manufacturers and authorized distributors. This article explores the leading suppliers of Mydriacyl, analyzing their market roles, geographic footprints, and strategic importance in supply continuity and innovation.
Overview of Mydriacyl Production and Market Dynamics
Mydriacyl (tropicamide) is classified under anticholinergic agents. Its manufacturing involves sophisticated chemical synthesis procedures, stringent quality control measures, and adherence to regulatory standards such as the FDA (U.S.), EMA (EU), and other regional agencies. The global ophthalmic pharmaceutical market's growth, driven by increased prevalence of eye diseases and expanding ophthalmology services, sustains demand for tropicamide formulations.
The manufacturing landscape for tropicamide includes both pioneering pharmaceutical companies and generic drug producers, with major players vying for market share to ensure supply stability.
Key Pharmaceutical Suppliers of MYDRIACYL
1. Alcon (Novartis Group)
Profile and Market Position:
Alcon is one of the world’s leading eye care companies, with an extensive portfolio encompassing surgical, vision care, and ophthalmic pharmaceutical products [1]. The company produces Mydriacyl as part of its ophthalmic solutions portfolio, supplied globally through authorized distributors and direct channels.
Supply Network and Distribution:
Alcon's robust global manufacturing infrastructure and supply chain logistics enable consistent availability of tropicamide formulations. The company’s rigorous regulatory compliance and quality assurance guarantee product integrity across markets.
Strategic Significance:
As a market leader, Alcon’s supply stability impacts global availability, especially in North America, Europe, and select Asian markets.
2. Santen Pharmaceutical Co., Ltd.
Profile and Market Position:
Santen, a Japanese multinational, specializes in ophthalmic drugs, including mydriatics like tropicamide. Its focus on ophthalmology grants it a significant foothold in Asia and emerging markets.
Supply Network and Distribution:
Santen operates manufacturing facilities in Japan and other countries, with a distribution network covering Asia, the Middle East, and Latin America. The company emphasizes research-driven formulations and high-quality standards.
Strategic Significance:
Santen’s role as an authorized supplier especially in Asian markets makes it a vital link in the global supply chain.
3. Akorn (A KrKA Company)
Profile and Market Position:
Akorn manufactures generic ophthalmic drugs, including tropicamide eye drops. Known for its cost-effective products, Akorn supplies to hospitals, clinics, and pharmacies worldwide.
Supply Network and Distribution:
With manufacturing facilities in the U.S. and Europe, Akorn's products are distributed through a broad network, supporting the accessibility of Mydriacyl equivalents and generics.
Strategic Significance:
Akorn's ability to produce high-quality generics broadens consumer access and maintains competitive pressure in the market.
4. Hunan Haiou Pharmaceutical Co., Ltd.
Profile and Market Position:
A key Chinese player, Hunan Haiou produces tropicamide-based ophthalmic solutions tailored for the Asian market and emerging economies.
Supply Network and Distribution:
The company operates a vertically integrated supply chain, ensuring affordability and availability in regions with high demand for cost-effective ophthalmic drugs.
Strategic Significance:
Hunan Haiou's growth aligns with expanding healthcare infrastructure in developing countries, making it an important regional supplier.
5. Mfr. Serb, Inc. (Part of the MFR Group)
Profile and Market Position:
Specializing in ophthalmic compounds, this manufacturer supplies tropicamide formulations to various international markets, emphasizing quality and regulatory compliance.
Supply Network and Distribution:
Supports distribution through licensed distributors across Africa, Southeast Asia, and Latin America.
Strategic Significance:
Its emergent market role supports supply diversification, especially in regions where western manufacturers face regulatory or logistical challenges.
Notable Distributors and Authorized Resellers
Apart from direct manufacturers, a significant part of the Mydriacyl supply chain involves authorized distributors and pharmacy chains.
- McKesson Corporation: Distributes ophthalmic pharmaceuticals in North America, including tropicamide formulations.
- Viatris (formerly part of Pfizer): Supplies across Europe and emerging markets.
- Sun Pharmaceutical Industries Ltd.: Offers generics and branded ophthalmic solutions, including tropicamide in India and neighboring countries.
Regulatory and Supply Chain Challenges
- Regulatory Alignment: Ensuring product approval across different jurisdictions influences available suppliers and market access.
- Manufacturing Constraints: Supply disruptions can arise from raw material shortages, manufacturing delays, or quality compliance issues.
- Intellectual Property and Patents: While tropicamide itself is patent-expired, formulation-specific patents can limit generic entry.
- Global Events: The COVID-19 pandemic underscored vulnerabilities in supply chains, emphasizing supplier diversity and local manufacturing.
Emerging Trends and Strategic Considerations
- Localization of Production: To mitigate geopolitical risks, many regional players are establishing local manufacturing.
- Quality Standard Harmonization: Suppliers adhering to international standards (FDA, EMA, WHO) command higher trust and market acceptance.
- Innovation in Formulations: R&D efforts aim to develop preservative-free, sustained-release, or combination ophthalmic drugs, influencing future supplier offerings.
- Supply Chain Transparency: Stakeholders increasingly demand detailed tracking from raw materials to finished products to ensure safety and compliance.
Conclusion
The supply landscape for Mydriacyl underscores a network of established pharmaceutical giants, regional manufacturers, and authorized distributors. Companies like Alcon and Santen maintain dominant roles through extensive global infrastructure and rigorous quality standards, ensuring reliable access in developed markets. Meanwhile, emerging regional manufacturers expand regional supply capacities, contributing to broader accessibility.
A resilient supply chain for tropicamide hinges on geographical diversification, regulatory harmonization, and ongoing innovation. Business decision-makers must monitor these dynamics to safeguard supply continuity, leverage competitive advantages, and navigate regulatory complexities effectively.
Key Takeaways
- Major Suppliers: Alcon, Santen, Akorn, Hunan Haiou, and regional manufacturers like Mfr. Serb play critical roles in Mydriacyl supply.
- Supply Chain Stability: Ensured through diversified manufacturing bases and adherence to international standards.
- Market Dynamics: Growing ophthalmic market and regional expansion drive supplier diversification.
- Regulatory Compliance: Critical for global market access and uninterrupted supply.
- Emerging Trends: Localization, innovation, and transparency will shape future supply chains.
FAQs
1. Are there generic equivalents of Mydriacyl available globally?
Yes, multiple manufacturers produce generic tropicamide formulations, which are approved in various regions, providing cost-effective alternatives to branded Mydriacyl.
2. Which regions have the most robust supply of tropicamide?
North America (via Alcon, McKesson), Europe (via Mfr. Serb, Sun Pharma), and Asia (via Santen, local manufacturers) have the most reliable supply networks due to mature healthcare systems and regulatory infrastructure.
3. What are the primary challenges in sourcing Mydriacyl?
Challenges include regulatory delays, raw material shortages, manufacturing disruptions, and geopolitical tensions impacting supply chain stability.
4. How do regional manufacturers impact global supply?
Regional manufacturers facilitate localized supply, reduce dependency on imports, and improve access in developing markets, thereby enhancing overall availability.
5. What future trends could influence Mydriacyl supplier dynamics?
Advancements in formulation technology, regional manufacturing capacity building, and stricter regulatory standards will significantly influence supply stability and supplier competition.
References:
[1] Alcon Official Website. "Our Portfolio," 2023.
[2] Santen Pharmaceutical Corporate Report. "Global Ophthalmic Products," 2022.
[3] Akorn Inc. "Annual Report," 2022.
[4] Hunan Haiou Pharmaceutical Co., Ltd. Official Website, 2023.
[5] MarketWatch. "Global Ophthalmic Drugs Market," 2022.
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