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Suppliers and packagers for MAXIDEX
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MAXIDEX
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Harrow Eye | MAXIDEX | dexamethasone | SUSPENSION/DROPS;OPHTHALMIC | 013422 | NDA | Harrow Eye, LLC | 82667-600-05 | 1 BOTTLE, PLASTIC in 1 CARTON (82667-600-05) / 5 mL in 1 BOTTLE, PLASTIC | 2025-04-07 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: MAXIDEX
Overview of MAXIDEX
MAXIDEX (dexamethasone ophthalmic emulsion) is a patented corticosteroid medication primarily used to treat inflammatory conditions of the eye, including post-operative inflammation, anterior uveitis, and allergic conjunctivitis. Its therapeutic efficacy owes to dexamethasone's anti-inflammatory and immunosuppressive properties. As a specialized ophthalmic product, MAXIDEX's supply chain involves multiple stakeholders, from raw material suppliers to manufacturing and distribution channels.
Understanding the key suppliers involved in the production of MAXIDEX provides insights into the pharmaceutical supply ecosystem, risk management strategies, and potential avenues for strategic partnerships. This analysis aims to delineate suppliers contributing to the active pharmaceutical ingredient (API), excipients, packaging, and other critical components.
Active Pharmaceutical Ingredient (API) Suppliers
Dexamethasone, the API in MAXIDEX, is synthesized via complex organic chemical processes. The sourcing of high-quality dexamethasone is pivotal, influencing drug efficacy, safety, and regulatory compliance. Major API suppliers in the corticosteroid class highlighted in industry reports include:
1. Dr. Reddy’s Laboratories
- Location: India
- Profile: A global supplier known for manufacturing dexamethasone API with regulatory approval in multiple jurisdictions. Offers consistent quality with ISO certifications and stringent pharmacopeial standards.
- Relevance: Dr. Reddy’s API production capabilities make it a candidate supplier for ophthalmic corticosteroids like dexamethasone, often supplied to both generic and branded formulations.
2. Cipla Ltd.
- Location: India
- Profile: A leading pharmaceutical company with a robust API manufacturing unit that produces dexamethasone. Known for adherence to WHO-GMP standards, Cipla supplies APIs to its own formulations and third-party manufacturers globally.
3. Sun Pharmaceutical Industries
- Location: India
- Profile: A major generic pharmaceutical manufacturer with extensive API production facilities, including corticosteroids like dexamethasone. Sun Pharma’s API meets regulatory requirements for markets such as the US (FDA-approved facilities) and Europe.
4. Mylan (now part of Viatris)
- Location: Global (with manufacturing units in India and Europe)
- Profile: Produces dexamethasone API for both proprietary and generic formulations. Mylan’s scaled API manufacturing capabilities ensure a steady supply chain for corticosteroids.
5. Sigma-Aldrich (a Merck subsidiary)
- Location: Global
- Profile: Specializes in research-grade APIs and pharmaceutical intermediates. Although primarily serving research and development, Sigma-Aldrich provides high-purity dexamethasone suitable for clinical and production use.
Supply Chain Consideration: The API suppliers’ regulatory approvals, manufacturing standards, and capacity directly impact MAXIDEX’s production continuity and compliance with global standards (e.g., FDA, EMA, CDSCO).
Excipients and Formulation Components
MAXIDEX’s formulation includes various excipients such as preservatives, stabilizers, and emulsifiers.
1. Benzalkonium Chloride
- Supplier Profile: Multiple suppliers including Vishnu Chemicals and Analeo Chemicals supply benzalkonium chloride, a common preservative in ophthalmic preparations.
2. Mineral Oil and Emulsifiers
- Supplier Profile: Companies like BASF and DowDuPont supply pharmaceutical-grade mineral oil and emulsifying agents critical in ophthalmic emulsions.
3. Water for Injection and Buffering Agents
- Supplier Profile: Water purification systems are supplied by specialized vendors like Pall Corporation. Buffering agents are sourced from recognized pharmaceutical raw material suppliers.
Packaging Suppliers
Ophthalmic medications necessitate specialized packaging to ensure sterility, stability, and patient safety.
1. Glass Vials
- Suppliers: Schott AG and Corning Incorporated provide borosilicate glass vials compliant with pharmacopeia standards.
2. Dropper Assemblies
- Suppliers: West Pharmaceutical Services and Nemera supply sterile, leak-proof dropper tips designed for ophthalmic products.
3. Secondary Packaging
- Suppliers: Packaging firms specializing in pharmaceutical cartons, labels, and sealing components secure compliance with regulatory and branding requirements.
Distribution and Supply Chain Dynamics
Once manufactured, MAXIDEX products are distributed globally through a network involving:
- Wholesalers and Distributors: Ensure broad geographic reach; prominent players include McKesson and Cardinal Health.
- Regulatory Approvals: Suppliers and manufacturers must comply with regional regulatory agencies such as the FDA (United States), EMA (European Union), and CDSCO (India).
- Logistical Providers: Cold chain and temperature-sensitive logistics providers like DHL Supply Chain and FedEx ensure product integrity during transit.
Key Considerations in Supplier Selection for MAXIDEX
- Regulatory Compliance: Suppliers must adhere to Good Manufacturing Practices (GMP), ISO standards, and region-specific approvals.
- Quality Assurance: Consistent supply of high-purity API and excipients is non-negotiable.
- Capacity and Scalability: Suppliers should provide reliable volume to meet market demand without supply disruptions.
- Cost Effectiveness: Competitive pricing without compromising quality influences profitability and pricing strategies.
- Supply Chain Resilience: Diversifying sources minimizes risks from geopolitical or manufacturing disruptions.
Industry Trends Affecting Supplier Selection
- Global API Production Shift: Increasing API manufacturing in India and China to reduce costs, which has increased dependency on Asian suppliers.
- Regulatory Tightening: Stricter quality controls and documentation requirements influence supplier qualification.
- Supply Chain Disruptions: The COVID-19 pandemic exposed vulnerabilities; companies now seek diversified and flexible supplier networks.
- Environmental and Sustainability Standards: Growing emphasis on green chemistry and sustainable sourcing influences supplier partnerships.
Key Takeaways
- MAXIDEX relies on a network of suppliers for dexamethasone API, excipients, and packaging components.
- India-based manufacturers like Dr. Reddy’s, Cipla, and Sun Pharma lead API supply, given their substantial capacity and regulatory compliance.
- Ingredient quality, regulatory approval, and supply stability are critical criteria for supplier selection.
- Packaging suppliers such as Schott and West Pharmaceutical Services ensure the integrity and sterility of ophthalmic formulations.
- Strategic diversification and compliance with evolving regulations underpin supply resilience amid global disruptions.
FAQs
1. Who are the primary API suppliers for MAXIDEX?
Major API suppliers include Dr. Reddy’s Laboratories, Cipla, Sun Pharmaceutical Industries, and Mylan, all of which produce dexamethasone API according to international standards.
2. How do excipient suppliers impact MAXIDEX production?
Excipients such as preservatives and stabilizers must meet strict pharmacopeial standards; reliable suppliers like Vishnu Chemicals and DowDuPont play a crucial role in ensuring formulation stability and safety.
3. Are there regional differences in MAXIDEX suppliers?
Yes. While global companies supply key components, regional regulations and manufacturing capacity influence supplier choices—India and China are dominant API sources, with European and North American firms providing packaging and raw materials.
4. How does supply chain resilience affect MAXIDEX manufacturing?
Supply chain disruptions can delay production or increase costs. Diversifying suppliers, maintaining strategic inventories, and ensuring regulatory compliance mitigate these risks.
5. What trends influence future supplier dynamics for ophthalmic drugs like MAXIDEX?
Increasing regulatory scrutiny, emphasis on sustainability, and supply chain digitization will shape supplier selection and partnerships moving forward.
References
[1] Pharmaceutical technology reports on corticosteroid API manufacturing.
[2] FDA pharmaceutical supplier qualification standards.
[3] Industry analyses on ophthalmic drug supply chains.
[4] Regulatory and quality compliance documentation from leading suppliers.
[5] Market intelligence platforms like IQVIA and EvaluatePharma.
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