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Suppliers and packagers for DEPAKOTE
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DEPAKOTE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Abbvie | DEPAKOTE | divalproex sodium | CAPSULE, DELAYED REL PELLETS;ORAL | 019680 | NDA | AbbVie Inc. | 0074-6114-13 | 100 CAPSULE in 1 BOTTLE (0074-6114-13) | 1989-09-12 |
| Abbvie | DEPAKOTE | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 018723 | NDA | AbbVie Inc. | 0074-7325-13 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0074-7325-13) | 1983-03-10 |
| Abbvie | DEPAKOTE | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 018723 | NDA | AbbVie Inc. | 0074-7326-13 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0074-7326-13) | 2023-06-30 |
| Abbvie | DEPAKOTE | divalproex sodium | TABLET, DELAYED RELEASE;ORAL | 018723 | NDA | AbbVie Inc. | 0074-7327-13 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0074-7327-13) | 1983-03-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DEPAKOTE
Introduction
DEPAKOTE, the brand name for divalproex sodium, is a widely prescribed anticonvulsant medication primarily used for epilepsy, bipolar disorder, and migraine prophylaxis. As a vital pharmaceutical product, its supply chain is complex, involving multiple suppliers across different manufacturing stages—from active pharmaceutical ingredient (API) production to finished dosage forms. Ensuring a reliable, compliant, and high-quality supply chain is critical for healthcare providers and pharmaceutical companies. This article provides a comprehensive overview of DEPAKOTE suppliers, examining the key players in API manufacturing, formulation, and distribution channels, alongside associated regulatory considerations.
1. Manufacturing and Supply Chain Overview
DEPAKOTE's supply chain components include:
- Active Pharmaceutical Ingredient (API) Suppliers
- Formulation and Finished Dosage Form Manufacturers
- Packaging and Distribution Entities
Each stage involves rigorous quality control and adherence to regulatory standards to ensure consistent drug safety and efficacy.
2. API Suppliers for Divalproex Sodium
The foundation of DEPAKOTE’s supply chain lies in the procurement of divalproex sodium API. Several manufacturers globally produce this API, subject to stringent Good Manufacturing Practice (GMP) standards.
2.1 Major API Manufacturers
a. Teva Pharmaceutical Industries Ltd.
Teva is among the largest API producers globally, with extensive facilities dedicated to antiepileptic drug APIs. Its divalproex sodium API manufacturing capacity supports its broad portfolio, including DEPAKOTE.
b. Pillarpoint Pharma (formerly part of Lach Dhalgan Group)
Pillarpoint Pharma is a prominent supplier based in India, offering APIs for divalproex sodium with a focus on compliance with international standards.
c. Hetero Labs Limited
India-based Hetero is a key API supplier, with regulatory approvals in major markets. Its manufacturing campuses follow strict GMP regulations, producing APIs for both branded and generic pharmaceuticals.
d. Torrent Pharmaceuticals
Torrent supplies divalproex sodium API, supplying both domestic and export markets, emphasizing quality and affordability.
e. Other Synthesizers and Contract Manufacturers
Contract manufacturing organizations (CMOs) globally also produce divalproex sodium APIs under licensing agreements, expanding the supply potential.
2.2 Regulatory and Quality Considerations
Manufacturers must comply with FDA, EMA, and other national regulatory standards. Recent Good Manufacturing Practices (GMP) audits are critical to ensure API quality, particularly given the risk of contamination or batch inconsistencies affecting patient safety [1].
3. Finished Dosage Form Manufacturers
Many pharmaceutical companies produce DEPAKOTE formulations, often through licensing agreements with the original patent holders.
3.1 Johnson & Johnson (Janssen Pharmaceuticals)
Janssen, a division of Johnson & Johnson, originally developed DEPAKOTE and continues to manufacture and market the drug globally. Its manufacturing facilities in the US, EU, and other regions ensure supply chain resilience.
3.2 Mylan (now part of Viatris)
Mylan produces generic versions of divalproex sodium, often under various brand names or as store brands. Their extensive manufacturing network supports a wide distribution footprint.
3.3 Sun Pharmaceutical Industries
As one of India's leading pharmaceutical companies, Sun Pharma manufactures generic divalproex sodium formulations and supplies multiple markets.
3.4 Other Generic Manufacturers
- Glenmark Pharmaceuticals
- Lupin Limited
- Dr. Reddy’s Laboratories
- Zydus Cadila
These companies provide generic alternatives, expanding supply options and increasing access to cost-effective therapies.
4. Distribution and Supply Chain Logistics
Post-manufacturing, DEPAKOTE’s distribution hinges on:
- Wholesale Pharmaceutical Distributors
- Regional and Local Pharmacies
- Online Pharmacies
Major distributors such as McKesson, Cardinal Health, and AmerisourceBergen facilitate widespread access. Ensuring cold chain and storage compliance is vital, especially in emerging markets, to maintain drug stability and efficacy.
5. Supply Chain Risks and Challenges
- Regulatory Discrepancies: Variations in regulatory standards can cause supply disruptions if manufacturers lack approvals across key markets.
- API Shortages: Disruptions in API production, due to contamination issues or capacity limitations, can lead to shortages of DEPAKOTE.
- Patent and Licensing Issues: Patent expirations and licensing agreements influence generic competition and supply dynamics.
- Quality Compliance: Maintaining GMP standards across all suppliers mitigates risks of substandard batches reaching patients.
6. Regulatory and Legal Considerations
Manufacturers and distributors must maintain strict compliance with FDA, EMA, and other regulatory agencies. The importation, registration, and licensing of APIs and finished products require continuous oversight to prevent supply interruptions and ensure patient safety [2].
Conclusion
The supply of DEPAKOTE involves a diversified network of API producers—primarily from India and Israel—and numerous formulation manufacturers, including Janssen and various generics producers globally. Ensuring a resilient and compliant supply chain is paramount, given the drug’s critical role in managing epilepsy, bipolar disorder, and migraines. Stakeholders must vigilantly monitor API quality, regulatory statuses, and manufacturing capacities to mitigate shortages and maintain uninterrupted patient access.
Key Takeaways
- The primary API suppliers for DEPAKOTE are Teva, Hetero, Pillarpoint Pharma, and Torrent Pharmaceuticals, among others.
- Original patent holder Janssen Pharmaceuticals maintains significant manufacturing and distribution responsibilities, complemented by generic manufacturers like Mylan and Sun Pharma.
- A multi-tiered supply chain subject to regulatory compliance is essential to prevent shortages and ensure safety.
- Supply chain risks primarily stem from API shortages, regulatory inconsistencies, and quality lapses, necessitating comprehensive risk management strategies.
- Continuous monitoring of supplier compliance, capacity, and regulatory status is crucial for pharmaceutical companies and healthcare providers.
FAQs
1. Who are the main API suppliers for DEPAKOTE?
Teva, Hetero Labs, Pillarpoint Pharma, and Torrent Pharmaceuticals are prominent API producers for divalproex sodium used in DEPAKOTE.
2. Are there generic alternatives to DEPAKOTE?
Yes. Several generic manufacturers, including Mylan, Sun Pharma, and Lupin, produce divalproex sodium formulations that serve as alternatives to the brand-name DEPAKOTE.
3. How does regulatory compliance impact DEPAKOTE’s supply chain?
Regulatory approval ensures API and finished product quality, reduces risk of shortages, and maintains market access across regions. Non-compliance can lead to delays or bans.
4. What risks threaten the supply chain of DEPAKOTE?
API shortages, quality lapses, regulatory non-compliance, and patent issues are primary risks. Geopolitical factors and manufacturing disruptions also pose threats.
5. How do quality standards influence DEPAKOTE manufacturing?
Strict adherence to GMP ensures the safety, efficacy, and consistency of both API and finished drugs, minimizing adverse events and supply failures.
Citations
[1] U.S. Food and Drug Administration. Good Manufacturing Practice (GMP) Regulations.
[2] European Medicines Agency. Guidelines on Good Manufacturing Practice.
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