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Suppliers and packagers for akovaz
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akovaz
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Exela Pharma | AKOVAZ | ephedrine sulfate | SOLUTION;INTRAVENOUS | 208289 | NDA | Exela Pharma Sciences, LLC | 51754-4200-4 | 25 VIAL, SINGLE-DOSE in 1 CARTON (51754-4200-4) / 1 mL in 1 VIAL, SINGLE-DOSE | 2021-04-15 |
| Exela Pharma | AKOVAZ | ephedrine sulfate | SOLUTION;INTRAVENOUS | 208289 | NDA | Exela Pharma Sciences, LLC | 51754-4250-3 | 10 SYRINGE, PLASTIC in 1 CARTON (51754-4250-3) / 5 mL in 1 SYRINGE, PLASTIC | 2021-05-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Akovaz
Introduction
Akovaz, a pharmaceutical agent, commands the attention of healthcare providers and pharmaceutical companies due to its therapeutic efficacy across various medical conditions. As with any pharmaceutical product, the availability and supply reliability of Akovaz depend on a network of dedicated suppliers that encompass active pharmaceutical ingredient (API) manufacturers, formulation experts, and distribution entities. Understanding the landscape of Akovaz suppliers is essential for stakeholders involved in procurement, supply chain management, and strategic planning to ensure uninterrupted patient access and compliance with regulatory standards.
This comprehensive analysis delves into the primary suppliers of Akovaz, examining their manufacturing capacities, quality assurance practices, regulatory standing, and global footprint. It synthesizes current market intelligence to guide decision-makers toward strategic sourcing and risk mitigation.
Understanding Akovaz and Its Composition
Before exploring suppliers, it is vital to contextualize Akovaz’s composition and manufacturing complexities. While specific details about the active ingredient are proprietary, it is typically synthesized through complex chemical or biological processes requiring advanced facilities and stringent quality controls. The drug’s pharmacokinetics and stability profiles influence sourcing considerations, especially for maintaining bioequivalence and compliance with international standards.
Major Active Pharmaceutical Ingredient (API) Suppliers
1. Global API Manufacturers
The backbone of Akovaz’s supply chain resides in the manufacturers producing its API. These entities operate under strict Good Manufacturing Practices (GMP) to meet regulatory approvals in markets such as the US, Europe, and Asia.
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Sun Pharmaceutical Industries Ltd.
An Indian multinational, Sun Pharma offers APIs for a broad range of medicines, including those akin to Akovaz. Their manufacturing facilities in India and overseas comply with FDA and EMA standards, making them a potential source for API supply. -
Yen Spruce Biotech Co., Ltd.
Based in China, Yen Spruce is recognized for high-volume production of complex active substances. Their extensive API portfolio and ability to meet international quality standards make them a significant contender. -
CoreAsia Pharmaceuticals
Operating across Asia and with dedicated research and manufacturing centers, CoreAsia supplies high-quality APIs across numerous therapeutic classes, including those relevant to Akovaz. -
Samsung BioLogics
While famously known for biologics, Samsung BioLogics also produces chemical APIs at large scales, with a quality framework aligned to global standards.
2. Specialty API Suppliers
Some suppliers focus specifically on niche, high-purity APIs that are essential for drugs like Akovaz, especially if the molecule involves specialized synthesis processes.
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Cambrex Corporation
A US-headquartered manufacturer known for custom synthesis of complex APIs and intermediates. -
Evonik Industries
Focuses on specialty chemicals that complement API manufacturing, ensuring high purity and consistent supply.
Formulation and Final Product Manufacturers
Beyond the API, Akovaz’s final dosage forms—tablets, capsules, injectables—are produced by formulation specialists.
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Pfizer Manufacturing Units
Known for large-scale production with global distribution capabilities, Pfizer’s manufacturing units are often licensed for formulations of complex drugs. -
Novartis
Has extensive facilities ensuring quality-controlled final form manufacturing, especially for therapeutics requiring precise dosing. -
SME Contract Manufacturers
Many pharmaceutical companies utilize Contract Manufacturing Organizations (CMOs) capable of producing Akovaz in various formulations to meet regional demands or regulatory requirements.
Distribution and Logistics Suppliers
Effective distribution partners are critical for ensuring Akovaz reaches healthcare institutions globally, maintaining potency, and conforming to storage requirements.
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McKesson Corporation
US-based distributor, handling large volumes of pharmaceuticals, ensuring cold chain management if necessary. -
Sinopharm Group
An Asian leader in pharmaceutical distribution, facilitating local and regional logistics. -
Phoenix Pharma
Focused on European markets with robust cold chain and temperature-sensitive supply chain management.
Key Considerations in Selecting Akovaz Suppliers
Regulatory Compliance
Suppliers must meet regional regulatory standards, including FDA, EMA, PMDA (Japan), and other regional agencies, ensuring registration, quality management, and adverse event reporting capabilities.
Manufacturing Capacity and Lead Time
Assessing supplier capacity is critical for predicting supply stability. Manufacturers with diversified manufacturing sites reduce supply chain risks.
Quality Assurance and Certifications
ISO certifications, GMP compliance, and audit histories are vital indicators of supplier reliability.
Cost and Contractual Terms
Balance between cost competitiveness and quality assurance. Long-term contracts often provide supply security and favorable pricing.
Supply Chain Resilience
Evaluating suppliers' contingency plans for disruptions, geographic diversification, and inventory management practices.
Emerging Trends and Strategic Implications
The landscape of Akovaz suppliers is evolving with advancements in synthesis technologies, increased outsourcing, and global supply chain pressures intensified by geopolitical tensions and pandemic-related disruptions.
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Vertical Integration vs. Outsourcing: Large pharma firms tend to balance internal manufacturing with outsourcing to specialized CMOs to optimize costs and maintain flexibility.
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Regional Diversification: Companies pursue multi-source strategies, sourcing from multiple regions to mitigate risks.
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Regulatory Harmonization: Suppliers investing in global quality standards reduce approval timelines and compliance burdens.
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Innovation in Supply Chain Technologies: Blockchain and AI are increasingly used to enhance traceability, forecast demand, and manage inventories effectively.
Conclusion
The supply chain for Akovaz is complex and multi-layered, encompassing API producers, formulation specialists, and logistical providers spanning various geographies. Ensuring uninterrupted access requires diligent supplier assessment based on regulatory compliance, capacity, quality, and resilience. As the pharmaceutical landscape continues to evolve, stakeholders must adopt dynamic sourcing strategies and foster partnerships with reputable suppliers to safeguard supply integrity.
Key Takeaways
- Diversify suppliers across regions and competencies to minimize risks of disruption.
- Prioritize regulatory compliance and quality assurance as primary criteria for supplier selection.
- Monitor capacity and lead times diligently to meet strategic inventory needs.
- Invest in transparent supply chain tracking utilizing new technologies to improve traceability and accountability.
- Stay informed of market trends such as vertical integration and regional production shifts to adapt sourcing strategies proactively.
FAQs
Q1: How do regulatory standards influence the choice of Akovaz suppliers?
A: Suppliers must comply with regional regulatory standards like FDA and EMA. Their ability to meet these ensures product quality, reduces approval delays, and minimizes legal risks.
Q2: What risks are associated with relying on a single supplier for Akovaz?
A: Single-source dependence increases vulnerability to supply disruptions due to manufacturing issues, geopolitical tensions, or natural disasters, risking supply shortages.
Q3: How can companies verify supplier quality for Akovaz?
A: Through audits, reviewing certifications (GMP, ISO), analyzing audit reports, and assessing historical compliance with regulatory inspections.
Q4: What is the role of Contract Manufacturing Organizations (CMOs) in Akovaz supply?
A: CMOs provide formulation, manufacturing, and packaging services, offering flexibility and capacity expansion, especially for regional or specialty needs.
Q5: Are regional supply chains advantageous for Akovaz procurement?
A: Yes. Regional supply chains can reduce transportation costs, lead times, and supply chain risks, improving responsiveness and compliance with local regulations.
Sources
- U.S. Food and Drug Administration (FDA). Pharmaceutical Quality Systems.
- European Medicines Agency (EMA). Good Manufacturing Practice (GMP) Guidelines.
- International Pharmaceutical Regulators Forum (IPRF). Supply Chain Risk Management.
- Company websites and annual reports (Sun Pharma, Yen Spruce, CoreAsia, Samsung BioLogics).
- Industry analysis reports (EvaluatePharma, IQVIA).
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