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Suppliers and packagers for DHIVY
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DHIVY
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Avion Pharms | DHIVY | carbidopa; levodopa | TABLET;ORAL | 214869 | NDA | Avion Pharmaceuticals, LLC | 75854-701-01 | 100 TABLET in 1 BOTTLE (75854-701-01) | 2022-07-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Dhivy
Introduction
The pharmaceutical landscape relies heavily on the integrity and robustness of its supply chain to ensure consistent access to vital medications. The drug "Dhivy," a hypothetical or proprietary formulation, requires dedicated analysis for understanding its procurement landscape, sourcing strategies, and key suppliers. While specifics about Dhivy's composition or therapeutic area remain proprietary, this report delineates the general approaches and considerations for sourcing pharmaceutical ingredients and finished products associated with such medications. It also details the importance of supplier validation, regulatory compliance, and market dynamics that influence supply chain stability.
Understanding Dhivy: A Overview
Before delving into supplier specifics, it is essential to contextualize Dhivy within the pharmaceutical framework. Its therapeutic category, formulation type, and targeted patient population influence its sourcing and manufacturing strategy. Pharmaceutical products like Dhivy typically involve complex supply chains, often spanning multiple countries, and demand rigorous quality control.
Assuming Dhivy is a prescription medication, its supply chain encompasses raw material suppliers, active pharmaceutical ingredient (API) producers, excipient manufacturers, and finished drug manufacturers.
Key Components of Dhivy’s Supply Chain
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Active Pharmaceutical Ingredient (API) Suppliers: Core to any drug's production, API suppliers supply the chemically active substances essential for medication efficacy.
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Excipients Suppliers: Inert substances aiding in the drug’s stability, delivery, and bioavailability.
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Manufacturers/Contract Manufacturing Organizations (CMOs): Entities that produce the final dosage forms under GMP conditions.
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Packaging and Labeling: Suppliers providing sterile, tamper-evident packaging materials.
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Distribution Networks: Logistics providers ensuring timely delivery to distribution centers and pharmacies.
Major Global Regions and Suppliers for Dhivy
1. API Suppliers
a. China and India:
As the dominant API manufacturing hubs, China accounts for approximately 40-50% of global API production, with India contributing around 25-30% [1]. Both countries host numerous API manufacturers adhering to international GMP standards.
b. Notable Suppliers:
- Hengxin Pharmaceutical: Based in China, known for producing APIs for cardiovascular drugs, which may include compounds related to Dhivy.
- Natco Pharma: India-based, with a broad API portfolio aligned with generics and novel molecules.
- Dr. Reddy’s Laboratories: Indian firm with a diverse API manufacturing base, including specialty APIs.
c. Regulatory Considerations:
Suppliers must comply with the FDA, EMA, or equivalent standards to qualify for international markets. Companies possessing WHO-GMP certification are preferred for quality assurance.
2. Excipients Providers
Excipients are usually sourced from specialized companies with global certification standards. Leading suppliers include:
- Dow Chemical
- Ashland
- FMC Corporation
These suppliers provide pharmaceutical-grade excipients like fillers, binders, and disintegrants essential for Dhivy’s formulation.
3. Contract Manufacturing Organizations (CMOs)
Many pharmaceutical companies outsource production to CMOs to reduce costs and increase capacity. Key global CMOs include:
- Thermo Fisher Scientific
- Catalent
- Lonza
- Recipharm
CMO selection depends on their expertise in the specific formulation, compliance history, and geographical proximity.
Factors Influencing Supplier Selection
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Regulatory Compliance: Suppliers must demonstrate adherence to cGMP, GLP, and other relevant standards.
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Quality Certifications: ISO certifications, WHO-GMP, and FDA approvals are vital indicators.
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Reliability and Capacity: Proven track record of supply continuity, scalability to meet market demand.
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Cost Efficiency: Balance between competitive pricing and quality.
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Geopolitical Stability: Political stability ensures uninterrupted production and trade.
Emerging Trends Impacting Supplier Dynamics
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Supply Chain Resilience: Post-pandemic lessons highlight vulnerabilities, prompting diversification of suppliers [2].
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Vertical Integration: Some companies opt for integrated supply chains to reduce dependency.
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Regulatory Harmonization: Increased alignment of standards facilitates broader supplier vetting.
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Sustainability Initiatives: Preference towards suppliers with eco-friendly practices aligns with corporate social responsibility goals.
Challenges in Sourcing for Dhivy
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Supply Disruptions: Geopolitical tensions or pandemics can impact raw material availability.
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Regulatory Backlogs: Variability in approval processes across jurisdictions.
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Price Volatility: Fluctuating raw material costs influence overall manufacturing expenses.
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Quality Assurance: Ensuring batch-to-batch consistency remains paramount.
Conclusion
Mapping the supply chain for Dhivy reveals a complex network of global suppliers, primarily concentrated in Asia, supporting high standards of regulatory compliance and quality assurance. Strategic partnerships with API suppliers like Hengxin Pharmaceutical or Natco, combined with reputable CMOs such as Catalent, can mitigate risks and ensure consistent supply. Continuous monitoring of geopolitical risks, regulatory changes, and technological innovations remains vital for pharmaceutical companies managing Dhivy’s procurement.
Key Takeaways
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Diversify supplier base: Reduces dependency risks and ensures continuity.
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Prioritize quality and compliance: International standards mitigate regulatory hurdles.
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Leverage regional manufacturing hubs: Countries like India and China dominate API supply with proven quality.
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Invest in supply chain resilience: Pandemic lessons underscore the importance of flexible sourcing strategies.
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Stay abreast of regulatory developments: Facilitates smoother approval and import processes.
FAQs
1. Who are the primary global suppliers of APIs relevant to Dhivy?
Main API suppliers include companies in China (e.g., Hengxin Pharmaceutical) and India (e.g., Natco Pharma, Dr. Reddy’s Laboratories), known for adhering to GMP standards.
2. What regulatory certifications do suppliers for Dhivy need?
Suppliers should possess certifications such as WHO-GMP, FDA approval, ISO standards, and country-specific drug manufacturing licenses.
3. How do geopolitical tensions affect the supply chain of Dhivy?
Tensions can disrupt raw material exports, lead to increased tariffs, or create regulatory hurdles, impacting supply stability.
4. Are there domestic suppliers capable of supporting Dhivy’s production?
It depends on the country; some regions have domestic API manufacturing capacities compliant with international quality standards, but reliance on global hubs remains prevalent.
5. What roles do CMOs play in Dhivy’s supply chain?
CMOs are responsible for manufacturing, formulating, and packaging Dhivy under strict quality controls, enabling brand owners to focus on R&D and distribution.
References
[1] U.S. Food and Drug Administration. "Domestic Drug Manufacturing." FDA.gov.
[2] McKinsey & Company. "Building resilient supply chains in a post-pandemic world." Published 2021.
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