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Suppliers and packagers for dilantin-30
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dilantin-30
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-30 | 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-30 | 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-30
Introduction
Dilantin-30, generic name phenytoin sodium extended-release capsules, remains a critical treatment for epilepsy and seizure management. Its supply chain encompasses a broad network of manufacturers, distributors, and generic equivalents, shaped by regulatory standards, manufacturing capacity, and global demand. For healthcare providers, pharmacists, and procurement professionals, understanding the suppliers of Dilantin-30 ensures consistent access, quality assurance, and strategic sourcing.
Manufacturers of Dilantin-30
Original Patent and Brand-Name Suppliers
Phenytoin sodium was originally developed and marketed by reputable pharmaceutical companies, with Pfizer Inc. historically serving as a primary manufacturer under the brand name Dilantin[1]. However, with patent expiration and the subsequent rise of generic options, the landscape shifted toward multiple manufacturers.
Generic Manufacturers
Today, numerous pharmaceutical firms produce both branded and generic phenytoin sodium extended-release capsules (30 mg). The primary suppliers include:
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Pfizer Inc.: While Pfizer's original patent has expired, the company continues to manufacture and distribute generic phenytoin formulations. Some formulations are marketed under proprietary names, but they often serve as suppliers for healthcare systems.
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Lupin Limited: An India-based pharmaceutical firm with robust production capacities for antiepileptic drugs, including extended-release phenytoin capsules[2].
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Mylan Pharmaceuticals (Now part of Viatris): Offers generic phenytoin sodium capsules, with extensive distribution networks globally[3].
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Hikma Pharmaceuticals: Known for manufacturing high-quality generic formulations, Hikma supplies phenytoin capsules to various markets[4].
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Teva Pharmaceuticals: As a leading generic manufacturer, Teva produces extended-release phenytoin capsules marketed across multiple regions[5].
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Cipla Ltd.: An Indian pharmaceutical giant with substantial generic formulations, including phenytoin, distributed internationally[6].
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Sun Pharmaceutical Industries: An additional key producer focused on neurological drugs, including phenytoin formulations[7].
Global and Regional Suppliers
The supply chain for Dilantin-30 extends across regions, with certain manufacturers dominating specific markets:
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United States: The Food and Drug Administration (FDA) approves generic formulations from companies like Mylan, Teva, and Pfizer. These firms ensure compliance with stringent quality standards mandated by the FDA.
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India and China: Major manufacturing hubs for generic pharmaceuticals, with Lupin, Cipla, and Sun Pharma exporting phenytoin to markets worldwide[8].
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Europe: European regulatory agencies accredit manufacturers such as Hikma and Teva, ensuring high standards for regional supply.
Regulatory and Quality Considerations
The bioequivalence and manufacturing quality of suppliers are paramount, especially for anti-epileptic drugs like Dilantin-30, where dosing consistency directly affects patient safety. Regulatory approvals from agencies like the FDA, EMA, and country-specific authorities serve as critical indicators of supplier reliability[9].
Supply Chain Challenges and Risks
The global pharmaceutical landscape faces disruptions due to manufacturing issues, supply chain logistics, and geopolitical factors. Notably:
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Supply shortages have occurred historically, influenced by manufacturing delays, raw material shortages, or regulatory actions[10].
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Quality concerns have led to recalls or market withdrawals, emphasizing the importance of sourcing from reputable suppliers with confirmed accreditation.
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Pricing pressures and patent expirations have increased the proliferation of generic manufacturers, expanding the supplier pool but also complicating quality assurance.
Supply Chain Strategy for Stakeholders
Healthcare entities should adopt comprehensive sourcing policies to ensure uninterrupted access:
- Maintain relationships with multiple suppliers for redundancy.
- Verify supplier regulatory compliance through certification and audit data.
- Monitor supply chain disruptions via market intelligence reports.
- Prioritize manufacturers with proven track records for quality and reliability.
Conclusion
The supply landscape for Dilantin-30 involves diverse manufacturers spanning global markets, primarily dominated by established generic pharmaceutical firms such as Mylan, Teva, Hikma, Lupin, and Cipla. The integrity of this supply hinges on regulatory compliance, manufacturing quality, and supply chain resilience. Stakeholders must adopt proactive strategies to navigate the complexities of sourcing this essential antiepileptic medication.
Key Takeaways
- A broad network of generic manufacturers supplies Dilantin-30, with key players including Mylan, Teva, Lupin, Hikma, and Cipla.
- Regulatory approvals and quality certifications are critical in evaluating supplier reliability.
- Regional variations influence the dominant suppliers, with Indian and European companies playing significant roles.
- Supply disruptions can arise from manufacturing or logistics issues, necessitating diversified sourcing strategies.
- Ongoing supplier monitoring and regulatory adherence are essential for maintaining consistent access to Dilantin-30.
FAQs
1. Who are the leading global suppliers of Dilantin-30?
The prominent suppliers include Mylan (Viatris), Teva Pharmaceuticals, Hikma Pharmaceuticals, Lupin Limited, and Cipla Ltd., all producing approved generic formulations for international markets.
2. How does regulatory approval impact the choice of supplier?
Regulatory approval ensures the supplier complies with safety, efficacy, and quality standards. Buyers should prioritize suppliers certified by agencies like the FDA, EMA, or equivalent authorities.
3. Are there differences between brand-name and generic Dilantin-30?
While bioequivalent in active ingredients, generics may differ in excipients, manufacturing processes, and release mechanisms. However, approved generics undergo rigorous testing to ensure therapeutic equivalence.
4. What are common challenges in sourcing Dilantin-30?
Challenges include supply shortages due to manufacturing delays, quality control issues, raw material shortages, and geopolitical disruptions affecting international logistics.
5. How can healthcare providers mitigate supply risks?
By establishing relationships with multiple accredited suppliers, maintaining inventory buffers, and continuously monitoring market trends and supply chain stability.
References
[1] U.S. FDA. Dilantin (Phenytoin Sodium) Capsules—Approved Drug Products. Accessed 2023.
[2] Lupin Limited. Product Portfolio — Antiepileptics. Accessed 2023.
[3] Viatris Inc. (formerly Mylan). Generic Phenytoin Capsules. Product details, 2023.
[4] Hikma Pharmaceuticals. Product Portfolio—Neurology. Accessed 2023.
[5] Teva Pharmaceuticals. Generic Seizure Medications. Accessed 2023.
[6] Cipla Ltd. Neurology Product Info. Accessed 2023.
[7] Sun Pharmaceutical Industries. Antiepileptic Drugs. Company website, 2023.
[8] World Health Organization. List of WHO Prequalified Pharmaceutical Products. 2023.
[9] European Medicines Agency. Overview of Antiepileptic Drug Approvals. 2023.
[10] U.S. FDA Saftey Alerts. Drug Shortage Reports. 2023.
By maintaining awareness of global suppliers and regulatory standards, healthcare stakeholders can secure reliable access to Dilantin-30, ensuring optimal patient care.
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