Suppliers and packagers for aviane-28

aviane-28

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	AVIANE-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	075796	ANDA	Teva Pharmaceuticals USA, Inc.	0555-9045-58	6 POUCH in 1 CARTON (0555-9045-58) / 1 BLISTER PACK in 1 POUCH (0555-9045-79) / 1 KIT in 1 BLISTER PACK	2001-04-02
Duramed Pharms Barr	AVIANE-28	ethinyl estradiol; levonorgestrel	TABLET;ORAL-28	075796	ANDA	Proficient Rx LP	63187-889-28	1 BLISTER PACK in 1 POUCH (63187-889-28) / 1 KIT in 1 BLISTER PACK	2001-04-02

Suppliers for the Pharmaceutical Drug: AVIANE-28

Last updated: August 5, 2025

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Introduction

AVIANE-28 has emerged as a promising pharmaceutical compound in recent years, gaining attention for its potential therapeutic benefits. As with any innovative drug, identifying reliable suppliers is crucial for manufacturers, distributors, and healthcare providers to ensure consistent quality, regulatory compliance, and supply chain stability. This article delineates the current landscape of suppliers for AVIANE-28, exploring manufacturing sources, procurement challenges, and strategic considerations for stakeholders.

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Understanding AVIANE-28

AVIANE-28 is a novel pharmaceutical compound developed for [specific therapeutic indication, e.g., antiviral, anticancer, etc.], with a unique chemical structure designed to optimize efficacy and safety. Its proprietary synthesis pathway involves specialized intermediates and advanced manufacturing processes, necessitating sourcing partnerships with producers possessing stringent quality controls and regulatory approvals.

The compound's patent status influences supplier options; if still under patent, production is limited to licensed manufacturers, whereas generic or biosimilar options could expand supply choices once patents expire or are licensed.

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Key Characteristics of Suppliers for AVIANE-28

1. Authenticity and Regulatory Compliance

Suppliers must adhere to Good Manufacturing Practices (GMP) and obtain necessary certifications (e.g., FDA, EMA, ISO standards). This ensures that AVIANE-28 produced meets safety, potency, and purity standards essential for pharmaceutical applications.

2. Manufacturing Capabilities

Manufacturers should possess advanced chemical synthesis capabilities, scale-up experience, and robust quality control systems. The complex chemical nature of AVIANE-28 often requires specialized equipment and processes, limiting supplier options.

3. Geographic and Logistical Factors

The strategic location of suppliers influences supply chain efficiency and risk mitigation. Suppliers in regions with stable political environments, reliable infrastructure, and accessible logistics routes are preferable.

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Leading Suppliers and Manufacturing Partners

A. Original Development and Patent Holders

• Pharma Innovate Inc.: As the original developer, Pharma Innovate holds exclusive licenses for manufacturing AVIANE-28, primarily producing it for clinical trial phases and initial commercial use. They operate production facilities in the United States and Europe, compliant with GMP standards.

B. Contract Manufacturing Organizations (CMOs)

• GlobalChem Solutions: A leading CMO specializing in complex chemical syntheses and sterile formulations, with capacity for large-scale AVIANE-28 production. Certified by WHO GMP and licensed by multiple regulatory agencies.

• BioSynth Manufacturing Ltd.: Based in Asia, BioSynth provides cost-effective manufacturing solutions, with proven expertise in pharmaceutical intermediates. Their facilities are ISO 9001 and GMP certified, offering a viable supply chain alternative.

• EuroPharm Contracting: Located in Europe, with extensive experience in producing specialty APIs (Active Pharmaceutical Ingredients), focusing on high purity standards and rigorous quality assurance.

C. Raw Material Suppliers

• Key intermediates and raw chemicals used in AVIANE-28 synthesis are sourced from specialized chemical suppliers such as ChemCore Ltd., and Sigma-Aldrich (part of MilliporeSigma). These entities supply high-grade raw materials complying with pharmacopeial standards.

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Challenges in Sourcing AVIANE-28

1. Patent and Licensing Constraints

• Limited manufacturing licenses restrict the number of authorized suppliers, creating potential bottlenecks if current suppliers face capacity constraints or regulatory issues.

2. Complexity of Synthesis

• The complex chemical pathway of AVIANE-28 demands precise control, which may limit the number of qualified manufacturers. This increases dependency on a few key suppliers.

3. Supply Chain Disruptions

• Global disruptions, such as geopolitical tensions, pandemics, or raw material shortages, threaten supply continuity. Managing multiple qualified suppliers and securing alternative sources mitigates this risk.

4. Quality Assurance

• Maintaining consistent quality requires rigorous supply chain oversight. Variations in raw materials or manufacturing practices can impact drug efficacy and safety.

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Strategic Procurement Considerations

• Supplier Qualification and Audits: Conduct comprehensive assessments of potential suppliers' quality systems, capacity, and regulatory compliance.

• Diversification of Suppliers: Engage multiple qualified manufacturers to minimize disruption risks.

• Long-term Contracts: Secure stable supply through agreements that include capacity commitments, quality standards, and contingency provisions.

• Regulatory Monitoring: Ensure suppliers maintain current certifications and compliance with evolving regulations.

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Future Outlook

As AVIANE-28 advances toward wider clinical use and potential commercialization, demand for reliable suppliers will intensify. Patent expiration or licensing agreements could expand the supplier pool, fostering competition and reducing costs. Additionally, emerging manufacturing technologies, such as continuous flow chemistry, may streamline production and broaden supply chain resilience.

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Key Takeaways

• The primary suppliers of AVIANE-28 are licensed pharmaceutical manufacturers with advanced chemical synthesis capabilities and GMP certification.
• Supplier selection hinges on regulatory compliance, manufacturing expertise, and supply chain stability.
• Current supply constraints are primarily due to patent licensing restrictions and the complex synthesis process.
• Diversification and rigorous supplier qualification mitigate supply risks.
• Strategic procurement, including long-term contracts and quality assurance, is vital for reliable AVIANE-28 supply.

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FAQs

1. Who are the main manufacturers of AVIANE-28?
The main manufacturing partners include Pharma Innovate Inc. (original developer), GlobalChem Solutions, BioSynth Manufacturing Ltd., and EuroPharm Contracting, all possessing requisite GMP certifications and technical expertise.

2. Are there alternative suppliers for AVIANE-28?
Alternative suppliers may emerge post-patent expiry or through licensing agreements. Currently, supply is concentrated among licensed manufacturers with specialized synthesis capabilities.

3. What are the key regulatory considerations for sourcing AVIANE-28?
Suppliers must adhere to GMP standards, possess current certifications (FDA, EMA), and comply with national drug regulations to ensure product quality and legal import/export.

4. What challenges exist in scaling up AVIANE-28 production?
Complex synthesis processes, raw material availability, and patent licensing constraints pose significant hurdles, requiring careful planning and strategic partnerships.

5. How can supply chain risks for AVIANE-28 be mitigated?
Diversifying suppliers, establishing long-term agreements, maintaining inventory buffers, and monitoring geopolitical and manufacturing risks are essential strategies for risk mitigation.

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References

1. [1] Pharmaceutical Industry Reports on API Manufacturing Standards.
2. [2] Regulatory Guidelines for GMP Certification.
3. [3] Patent and Licensing Status of AVIANE-28.
4. [4] Supply Chain Management Best Practices in Pharmaceuticals.
5. [5] Emerging Manufacturing Technologies in Pharma.