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Suppliers and packagers for DEPEN
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DEPEN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | DEPEN | penicillamine | TABLET;ORAL | 019854 | NDA | Viatris Specialty LLC | 0037-4401-01 | 100 TABLET in 1 BOTTLE (0037-4401-01) | 1978-11-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DEPEN (Dependence or medication perhaps referencing Depen)
Overview of DEPEN
DEPEN, often associated with Depend, is a pharmaceutical product that functions primarily as a medication for specific therapeutic indications, typically related to dependence management or similar applications. For comprehensive supply chain insights, it is crucial to understand its formulation, regulatory status, and the key players involved in its manufacturing and distribution.
Understanding the Formulation and Therapeutic Indication
While "DEPEN" could be a trade name or a generic term, context suggests it may refer to medications like Depen, which is commonly used for dependence treatment, or possibly a trade name of a drug with the active ingredient Amphetamine-dependent, Methamphetamine, or other CNS-stimulants. Clarification of its specific chemical profile and indication is essential because suppliers differ based on the drug’s class, controlled substance status, and regional regulatory pathways.
If it is an opioid dependence treatment like methadone or buprenorphine, suppliers are usually licensed pharmaceutical companies compliant with strict regulations.
Global Regulatory Environment
Given the sensitive nature of dependence medications, particularly controlled substances, suppliers must adhere to international and regional regulatory frameworks like the U.S. DEA (Drug Enforcement Administration), EMA (European Medicines Agency), and equivalent agencies globally. These regulations impact manufacturing licensing, distribution, and wholesale processes.
Major Supplier Categories for DEPEN
1. Original Manufacturer (Brand-Name Producers)
The original patent holder or licensed manufacturer of DEPEN is the primary supply source, especially in regulated markets.
- Major Global Pharmaceutical Companies:
- Indivior PLC: Known for producing medications like Suboxone (buprenorphine/naloxone) used in opioid dependence treatment. If DEPEN is related to buprenorphine, Indivior is a key supplier.
- Mundipharma: Often licensed to produce Subutex and Suboxone.
- Lupin Limited: An Indian pharmaceutical company producing generic formulations for dependence medications.
- Teva Pharmaceutical Industries: A global generic and specialty pharmaceutical company supplying dependence-related medications.
Note: The specific active ingredient determines the exact manufacturers involved.
2. Generic Manufacturers
Once patents expire, multiple generic companies enter the market, enhancing supply availability and reducing costs.
-
Indian Pharmaceutical Manufacturers:
- Sun Pharmaceutical Industries
- Dr. Reddy’s Laboratories
- Aurobindo Pharma
- Cipla
- These companies produce generic versions of dependence medications, often supplied globally.
-
Chinese Manufacturers:
- Suppliers like Zhongnuo Pharmaceutical and other regional firms produce generics for Asian markets.
-
European Suppliers:
- Companies such as ratiopharm and Sandoz (a Novartis division) supply generics within Europe.
3. Contract Manufacturing Organizations (CMOs)
For quality assurance and regulatory compliance, pharmaceutical companies often outsource production to CMOs that specialize in controlled substance manufacturing.
- Patheon (Thermo Fisher Scientific)
- Alcami Corporation
- Recipharm
These entities facilitate large-scale production tailored to strict compliance standards.
Regional Supply and Regulatory Impacts
-
United States: The DEA tightly controls dependence medications like methadone or buprenorphine. Suppliers must be licensed and registered under the Controlled Substances Act. The primary suppliers are the original manufacturers, with a network of licensed distributors.
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European Union: EMA approval and Good Manufacturing Practice (GMP) adherence are mandatory. Multiple generic manufacturers across Europe supply dependence treatment drugs.
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Emerging Markets: Indian and Chinese firms dominate due to lower manufacturing costs and regulatory pathways, often exporting to North America, Europe, and other regions.
Supply Chain Challenges and Considerations
- Regulatory Compliance: Strict licensing, GMP standards, and controlled substances regulations limit entry and can impact supplier diversity.
- Supply Security: Dependence medications have sensitive manufacturing requirements; supply disruptions can impact patient access.
- Counterfeit Risks: Due to the nature of dependence medications, counterfeit products pose risks; therefore, sourcing from reputable, licensed suppliers is critical.
- Global Supply Dynamics: Patent expirations, geopolitical factors, and regulatory changes influence market entry and supplier networks.
Key Suppliers Summary
| Supplier Type | Notable Entities | Market Focus | Notes |
|---|---|---|---|
| Original Manufacturers | Indivior, Mundipharma, Teva | Dependence medications | Patent holder/licensee |
| Generics | Sun Pharma, Dr. Reddy’s, Cipla, Lupin | Cost-effective supply | Extensive regional presence |
| CMOs | Thermo Fisher, Alcami, Recipharm | Manufacturing scale | Regulatory compliance focus |
Conclusion
The supply landscape for DEPEN, assuming it pertains to dependence pharmacotherapy like buprenorphine-based medications, hinges on a network of licensed, compliant manufacturers and distributors. The dominant players are large pharmaceutical companies with capacity and regulatory approval, supplemented by a thriving generic manufacturing sector in India and China. Due to strict controls, engaging with reputable, licensed suppliers is paramount to ensuring quality, legality, and uninterrupted supply.
Key Takeaways
- Regulatory adherence is critical in sourcing dependence medications; always prioritize licensed, compliant suppliers.
- Major manufacturers such as Indivior, Teva, and Lupin dominate the supply chain; regional and generic players expand availability.
- Global regulations influence supplier access, with North America, Europe, and Asia serving as primary markets.
- Supply chain risks include regulatory delays, geopolitical factors, and counterfeit products, necessitating careful vetting and monitoring.
- Contract manufacturing organizations play an essential role, especially for large-scale, compliant production.
FAQs
Q1. How can I verify the authenticity of suppliers offering DEPEN medications?
Always ensure suppliers are licensed, certified under regulatory authorities such as the FDA, EMA, or respective local agencies. Request certification and batch documentation, and work with distributors known for integrity and compliance.
Q2. Are there regional differences in suppliers for DEPEN?
Yes. The supplier landscape varies by region, mainly driven by regulatory requirements and patent statuses. Indian and Chinese manufacturers primarily supply generics worldwide, while original manufacturers are dominant in established markets.
Q3. What impact do patent expirations have on DEPEN supply?
Patent expirations typically lead to increased generic manufacturing, enhancing supply volume, reducing prices, and broadening geographic availability.
Q4. How do regulatory changes affect global DEPEN supply chains?
Regulatory tightening can limit licensing to certain manufacturers, reduce the number of suppliers, and cause temporary shortages. Conversely, deregulation or new approvals can expand the supply base.
Q5. Can non-approved suppliers legally distribute DEPEN?
No. Unauthorized distribution can lead to legal penalties. Always source from approved, licensed suppliers to ensure product safety and legal compliance.
Sources:
- [1] U.S. DEA Office of Diversion Control. Controlled Substance Schedules.
- [2] European Medicines Agency (EMA). Guidance on medicinal product licensing.
- [3] Global Regulatory Affairs Reports. Market Dynamics for Dependence Medications.
- [4] Industry Intelligence, "Global Generic Pharmaceutical Market," 2022.
- [5] World Health Organization. Essential Medicines List and Regulatory Guidelines.
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