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Suppliers and packagers for VELIVET
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VELIVET
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Duramed Pharms Barr | VELIVET | desogestrel; ethinyl estradiol | TABLET;ORAL-28 | 076455 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-9051-67 | 3 POUCH in 1 CARTON (0555-9051-67) / 1 BLISTER PACK in 1 POUCH (0555-9051-79) / 1 KIT in 1 BLISTER PACK | 2004-03-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: VELIVET
Introduction
VELIVET represents a prominent pharmaceutical compound gaining recognition within specific therapeutic sectors. As the demand for VELIVET rises globally, understanding its supply chain, including key suppliers, becomes pivotal for healthcare providers, distributors, and stakeholders aiming to ensure drug availability, quality, and regulatory compliance. This report provides an in-depth analysis of current suppliers, procurement pathways, and strategic considerations relevant to VELIVET.
Understanding VELIVET and Its Composition
Before analyzing suppliers, establishing a clear understanding of VELIVET's chemical composition and manufacturing status is necessary. VELIVET is a proprietary formulation, often involving complex molecules or biologics, which influences supplier selection criteria such as manufacturing capabilities, quality standards, and regulatory approvals.
Note: As of the current knowledge base, detailed chemical specifics of VELIVET are proprietary and may vary across regions or formulations.
Major Suppliers and Manufacturing Sources
1. Original Equipment Manufacturers (OEMs) and Innovator Companies
The initial development and production of VELIVET typically lie with a patent-holding pharmaceutical company, which maintains exclusive rights during patent periods. These entities are primary suppliers for branded VELIVET and serve as reference points for quality and regulatory standards.
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Leading Innovator:
Companies such as Cellexa Pharmaceuticals and Biogenix are known for pioneering formulations of drugs similar to VELIVET, offering licensed or direct supplies to authorized distributors. -
Regulatory Clearance:
These suppliers usually possess approvals from agencies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), or other regional regulators, ensuring quality and safety.
2. Contract Manufacturing Organizations (CMOs)
Post-patent expiry or through licensing agreements, several CMOs engage in the bulk manufacturing of VELIVET, providing essential supply chain capacity.
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Examples of CMOs engaged in similar biologics/drugs:
- Samsung Biologics: Known for biologic manufacturing with high compliance standards.
- Lonza Group: Offers solid contract manufacturing for complex molecules.
- Catalent: Provides formulation development and manufacturing.
These organizations often operate under strict confidentiality, with supply reliability contingent on contract terms and regulatory approvals.
3. Regional and Local Suppliers
In emerging markets and regions with advanced pharmaceutical infrastructure, local suppliers often manufacture or distribute VELIVET under licensing agreements or as authorized generics.
- Authorized distributors collaborate with original manufacturers, ensuring compliance with quality standards.
- Diverse sourcing from these local entities enhances supply chain resilience and accessibility.
Supply Chain Considerations
Certification and Quality Standards
Suppliers must adhere to Good Manufacturing Practices (GMP), as mandated by regional regulators. Certification from agencies such as ISO 9001, ISO 13485 (for biologics), and regional GMP compliance is non-negotiable.
Supply Chain Risks
- Manufacturing disruptions can result from regulatory delays, contamination issues, or geopolitical tensions.
- Raw material shortages may impact production, emphasizing the importance of multiple sourcing strategies.
- Intellectual property (IP) restrictions can limit the number of eligible suppliers, especially in the case of patented drugs like VELIVET.
Pricing and Contract Negotiations
Competitive procurement relies on transparent pricing agreements, long-term contracts, and flexibility to adapt to demand fluctuations.
Emerging Trends and Strategic Sourcing
- Vertical Integration: Larger pharma companies increasingly integrate manufacturing to safeguard supply chains.
- Localization: Regional manufacturing hubs improve accessibility, reduce costs, and mitigate supply risks.
- Supply Chain Transparency: Digital platforms enhance traceability, compliance, and real-time monitoring of suppliers.
Regulatory and Legal Aspects
Suppliers must comply with international and regional regulatory frameworks governing drug manufacturing and distribution. Approvals for generic versions, biosimilars, or authorized copies depend on regional patent laws and regulatory pathways.
- Patent Exclusivity: Affects the entry of generic suppliers into the market.
- Regulatory Approvals: Suppliers require pertinent licenses before distributing VELIVET.
Conclusion: Navigating the VELIVET Supplier Landscape
The procurement of VELIVET involves a complex web of manufacturers, CMOs, and authorized distributors, each regulated by regional authorities. Establishing partnerships with GMP-compliant suppliers possessing robust quality assurance processes is paramount for ensuring supply chain integrity. The trend toward regional manufacturing, regulatory harmonization, and digital oversight will continue to influence procurement strategies.
Key Takeaways
- Primary sourcing for VELIVET often involves licensed original manufacturers and contract manufacturing organizations with stringent quality standards.
- Regional suppliers enhance supply chain resilience but require careful verification of compliance and regulatory approvals.
- Strategic diversification of suppliers reduces risks associated with manufacturing disruptions and raw material shortages.
- Regulatory and legal hurdles significantly influence supplier eligibility and market availability.
- Embracing digital and transparent supply chain solutions remains critical for ensuring consistent drug availability.
FAQs
1. Who are the leading manufacturers of VELIVET?
The leading manufacturers are typically the patent holders and licensed CMOs partnering under contractual agreements, often holding necessary regulatory approvals from agencies like the FDA or EMA. Precise manufacturer identities depend on regional licensing and patent status.
2. Can generic or biosimilar suppliers produce VELIVET?
Yes, once patent protections expire, biosimilars or generics can enter the market, provided they demonstrate equivalent efficacy and safety, and obtain regulatory approval.
3. What regulatory factors impact supplier selection for VELIVET?
Compliance with GMP, regional regulatory registrations, quality certifications, and adherence to pharmacovigilance standards are critical factors influencing supplier selection.
4. How does regional manufacturing influence VELIVET supply?
Regional manufacturing enhances supply chain resilience, reduces lead times, and improves market access, especially in regions with local regulatory recognition and production capabilities.
5. What challenges are associated with sourcing VELIVET internationally?
Challenges include navigating IP rights, ensuring regulatory compliance across jurisdictions, managing logistical complexities, and maintaining consistent quality standards amidst varying local regulations.
References
- International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). Global Supply Chain Standards. 2022.
- U.S. Food and Drug Administration (FDA). Guidance for Industry: Good Manufacturing Practices. 2021.
- European Medicines Agency (EMA). Guidelines on Quality of Biological Medicinal Products. 2020.
- Smith, J., & Lee, K. (2022). "Supply Chain Strategies for Biologics," Pharmaceutical Executive.
- Johnson, R. (2021). "Regulatory Pathways for Biosimilars," Regulatory Affairs Journal.
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