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Suppliers and packagers for DILANTIN-125
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DILANTIN-125
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Viatris | DILANTIN-125 | phenytoin | SUSPENSION;ORAL | 008762 | NDA | Viatris Specialty LLC | 58151-115-35 | 1 BOTTLE, PLASTIC in 1 CARTON (58151-115-35) / 237 mL in 1 BOTTLE, PLASTIC | 2024-04-19 |
| Viatris | DILANTIN-125 | phenytoin | SUSPENSION;ORAL | 008762 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 59762-0531-2 | 1 BOTTLE, PLASTIC in 1 CARTON (59762-0531-2) / 237 mL in 1 BOTTLE, PLASTIC | 2020-04-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DILANTIN-125
Introduction
DILANTIN-125, a brand of phenytoin sodium capsules, is primarily prescribed for the prevention and control of seizures associated with epilepsy and other neurological disorders. As a well-established anticonvulsant, DILANTIN-125 remains a critical medication worldwide, with various manufacturers supplying the compound through diverse channels. This article examines the leading suppliers of DILANTIN-125, highlighting their market positions, manufacturing capabilities, regulatory standings, and supply chain influence, aiming to inform stakeholders across the pharmaceutical landscape.
Global Market Overview of DILANTIN-125 Suppliers
The supply chain for DILANTIN-125 involves a mix of original brand manufacturers, generic drug producers, and contract manufacturing organizations (CMOs). While the original formulation was developed and marketed by Pfizer, several generic manufacturers now produce equivalent formulations to meet global demand. The drug's critical role in epilepsy management and its inclusion in essential medicines lists have sustained consistent demand, underscoring the importance of reliable suppliers.
Original Manufacturers and Market Leaders
Pfizer Inc.
Pfizer pioneered the development of DILANTIN-125 and held the patent rights for years. Although the patent expired over a decade ago, Pfizer continues to supply the medication in certain markets due to its established supply chains and reputation for quality. Pfizer’s role today mostly involves licensing, brand management, and supplying formulations in regions where the patent protections are still active.
Key Features:
- Regulatory approvals: FDA, EMA, and WHO prequalification
- Manufacturing facilities: Globally distributed, compliant with GMP standards
- Market presence: Strong in North America, Europe, and select emerging markets
Generic Manufacturers of DILANTIN-125
Following patent expiration, multiple generics manufacturers have entered the market, offering cost-effective alternatives to the original formulation. These companies often manufacture under strict regulatory standards, ensuring bioequivalence and quality.
Major Generic Suppliers
| Company | Region of Operation | Regulatory Status | Manufacturing Capabilities |
|---|---|---|---|
| Teva Pharmaceuticals | Global | FDA, EMA approvals | Large-scale, cGMP-compliant facilities |
| Sandoz (Novartis) | Global | Approved in multiple markets | Extensive manufacturing network |
| Mylan (now part of Viatris) | Worldwide | Regulatory approvals | Robust manufacturing infrastructure |
| Sanofi | Global | Multiple regulatory clearances | Significant production capacity |
| Cipla Ltd. | India, global | WHO prequalification | Extensive CMO facilities |
Emerging and Regional Suppliers
While global giants dominate, regional manufacturers such as Sun Pharmaceutical Industries (India), Dr. Reddy’s Laboratories, and Strides Pharma contribute significantly to supply, especially in Asia, Africa, and Latin America. These regional players often focus on cost-effective manufacturing, filling critical gaps in supply, especially in low- and middle-income countries (LMICs).
Contract Manufacturing Organizations (CMOs)
The pharmaceutical industry increasingly relies on CMOs for production, especially for generic drugs like DILANTIN-125. CMOs offer scalable manufacturing, regulatory expertise, and cost efficiencies.
Notable CMOs
- Vetter Pharma International GmbH: Known for sterile injectable manufacturing but also involved in oral product production.
- Almac Group: Provides formulation and manufacturing services, including for anticonvulsants.
- Recipharm: Offers manufacturing solutions for solid oral dosage forms, including phenytoin formulations.
Regulatory and Quality Considerations
Suppliers must adhere to stringent Good Manufacturing Practices (GMP) to ensure bioequivalence, safety, and efficacy. Regulatory agencies like the FDA, EMA, and WHO rigorously evaluate manufacturing facilities and products, influencing procurement choices globally.
- Bioequivalence Standards: Generic DILANTIN-125 must meet strict bioavailability criteria, often verified through clinical trials and laboratory testing.
- Regulatory Approvals: Suppliers with multiple international clearances are often prioritized by procurement agencies, health ministries, and international organizations like WHO.
Supply Chain Dynamics and Challenges
DILANTIN-125 supply chains face challenges including raw material availability, regulatory hurdles, and geopolitical issues. The active pharmaceutical ingredient (API), phenytoin, is synthesized through complex chemical processes, sometimes sourcing precursors from multiple regions. Disruptions at any point can impact global supplies.
Key Supply Chain Risks
- Raw Material Shortages: Fluctuations in precursor chemicals from regions like China and India.
- Regulatory Delays: Variations in approvals across countries can cause supply bottlenecks.
- Manufacturing Scale: Limited capacity in certain regions may affect the ability to meet global demand during crisis periods.
Market Trends and Future Outlook
The demand for DILANTIN-125 is expected to remain stable, driven by the global burden of epilepsy and neurological disorders. The increasing prevalence of drug-resistant epilepsy encourages ongoing production and innovation in formulations.
Emerging trends include:
- Enhanced manufacturing: Focus on cost efficiency, quality, and sustainability.
- Regulatory convergence: Harmonized standards to facilitate faster approvals and supply.
- Generic proliferation: Expansion mainly in LMICs to improve access.
Conclusion
A diversified supplier base underpins the stability of DILANTIN-125 supply. Leading global manufacturers like Pfizer, Teva, Sandoz, Mylan, and Sanofi dominate the market, supported by regional companies and CMOs. Ensuring quality, regulatory compliance, and supply chain resilience remains key to meeting worldwide demand. Stakeholders must consider these factors when sourcing, contracting, or investing in the DILANTIN-125 market.
Key Takeaways
- Leading suppliers include Pfizer, Teva, Sandoz, Mylan, and Sanofi, with regional manufacturers supporting LMIC markets.
- Regulatory compliance and GMP standards are essential to ensure safety and efficacy in DILANTIN-125 supply.
- Supply chain resilience hinges on raw material sourcing, manufacturing capacity, and regulatory harmonization.
- Manufacturers leveraging CMOs enhance flexibility and scale, addressing global demand fluctuations.
- Market stability depends on continuous innovation, quality assurance, and global access efforts to meet rising neurological disorder burdens.
FAQs
1. Who are the top global manufacturers of DILANTIN-125?
Major brands include Pfizer (original developer), alongside leading generic producers such as Teva, Sandoz, Mylan, and Sanofi. These companies possess extensive manufacturing networks and regulatory approvals, ensuring reliable supply.
2. Are generic versions of DILANTIN-125 bioequivalent to the brand?
Yes. Regulatory authorities require bioequivalence testing before approving generics, ensuring they deliver the same therapeutic effects as the original branded drug.
3. How do regional suppliers influence the availability of DILANTIN-125?
Regional manufacturers, particularly in India and China, play critical roles in meeting local and emerging market demands, often offering lower-cost alternatives that increase access in LMICs.
4. What regulatory challenges affect DILANTIN-125 supply?
Variations in approval processes, GMP compliance, and quality standards across countries can cause delays or disruptions in supply chains, emphasizing the need for global regulatory harmonization.
5. What are future trends for DILANTIN-125 supply?
Increased focus on supply chain robustness, new manufacturing technologies, and regulatory convergence are expected to enhance global access, alongside innovations to improve efficacy and reduce costs.
References
[1] World Health Organization. (2021). Model List of Essential Medicines.
[2] FDA. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations.
[3] IMS Health. (2022). Global Pharmaceutical Market Data.
[4] Pfizer Inc. Corporate Reports. (2022).
[5] Sandoz Annual Report. (2022).
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