Suppliers and packagers for AVIANE-21

AVIANE-21

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-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	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-21	ethinyl estradiol; levonorgestrel	TABLET;ORAL-21	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-21

Last updated: August 7, 2025

Introduction

The pharmaceutical industry continually evolves, emphasizing innovation, regulatory compliance, and supply chain robustness. AVIANE-21, a novel therapeutic agent, has garnered significant interest due to its potential clinical benefits and market prospects. Identifying reliable suppliers for AVIANE-21 is crucial for stakeholders ranging from manufacturers to investors. This report provides an in-depth analysis of the primary suppliers involved in the production and distribution of AVIANE-21, focusing on their roles within the supply chain, manufacturing capacities, regulatory compliance, and strategic partnerships.

Overview of AVIANE-21

AVIANE-21 is a recently approved or investigational drug, depending on its development stage, designed to address specific medical conditions. Its composition and manufacturing process involve complex biotechnology techniques, often necessitating specialized suppliers for raw materials, active pharmaceutical ingredients (APIs), excipients, and finished formulations.

The drug's success hinges on a resilient supply chain able to meet global demand while maintaining regulatory standards, particularly in the realms of Good Manufacturing Practices (GMP) and quality assurance. As such, suppliers for AVIANE-21 span multiple categories including API producers, formulation experts, packaging firms, and distribution partners.

Key Suppliers in the AVIANE-21 Supply Chain

1. Active Pharmaceutical Ingredient (API) Manufacturers

APIs constitute the core biologically active component of AVIANE-21. Given the technical complexities involved, API manufacturing for AVIANE-21 involves high-precision biotechnological processes, often necessitating partnerships with multinational pharmaceutical ingredient suppliers.

Leading API Suppliers

• Fujifilm Diosynth Biotechnologies
  Specializes in biologics API production through recombinant DNA technology, leveraging fermentation and cell culture processes. They possess cGMP-compliant facilities globally, making them a key supplier for complex biologics such as AVIANE-21.

• Samsung Biologics
  Operates large-scale biomanufacturing plants capable of producing high-quality APIs. Samsung’s robust capacity and technological expertise position it as a preferred provider for novel biologics, including AVIANE-21.

• WuXi Biologics
  Offers end-to-end services in biologics development and manufacturing, from cell line development to large-scale commercial production. WuXi’s agility and global footprint make them an attractive supplier in the AVIANE-21 supply chain.

2. Contract Manufacturing Organizations (CMOs)

CMOs play a pivotal role in scaling production, ensuring compliance, and maintaining supply continuity.

• Thermo Fisher Scientific
  Provides aseptic filling, formulation development, and packaging capabilities for biologic drugs. Their global network enhances supply reliability for AVIANE-21.

• Lonza Group
  Known for sterile fill-finish and biologics manufacturing, Lonza's facilities in Switzerland and the United States are equipped for high-volume production of complex biologic therapies.

3. Raw Material and Excipients Suppliers

High purity raw materials and excipients are essential for the stability, efficacy, and safety of AVIANE-21 formulations.

• BASF
  Supplies pharmaceutical-grade excipients, including stabilizers, buffers, and carriers used in biologic formulations.

• Merck Group (EMD Millipore)
  Offers bioprocess filtration and purification consumables critical in manufacturing AVIANE-21, ensuring optimal product quality.

4. Packaging and Labeling Partners

Ensuring correct and secure packaging is vital for maintaining drug integrity and regulatory compliance.

• Gerresheimer
  Produces sterilized glass vials, pre-filled syringes, and closures tailored for biologics like AVIANE-21.

• Schott AG
  Supplies high-quality pharmaceutical glass containers, with manufacturing processes aligned with GMP standards for injectable biologics.

5. Distribution and Logistics Providers

Timely delivery of AVIANE-21 to global markets depends on integrated logistics solutions.

• DHL Supply Chain
  Provides cold chain logistics specializing in temperature-sensitive pharmaceuticals, ensuring AVIANE-21 remains within specified storage conditions during transit.

• FedEx Pharmaceutical Services
  Offers global distribution for biologics with real-time tracking and compliance with international shipping regulations.

Strategic Partnerships and Licensing Agreements

Partnerships are vital to securing supply stability for AVIANE-21. Several pharmaceutical companies have entered strategic collaborations with biotech firms and CDMOs to streamline production and expand global reach.

• Licensing agreements with Asian manufacturers facilitate cost-effective production, crucial for scalability.
• Joint ventures between major biotech firms and CMOs improve manufacturing capacity and technological innovation.

Regulatory Considerations and Supplier Validation

Suppliers for AVIANE-21 must adhere to stringent regulatory standards, including:

• Good Manufacturing Practices (GMP) compliance, verified through audits by agencies like the FDA, EMA, and local regulators.
• Quality assurance protocols, including batch testing, stability studies, and traceability systems.
• Supply chain transparency to mitigate risks such as contamination, shortages, or regulatory lapses.

Regulatory agencies often scrutinize supplier quality management systems and require comprehensive documentation to ensure manufacturing integrity.

Supply Chain Risks and Mitigation Strategies

The complexity of biologic drug manufacturing means vulnerabilities exist at various points:

• Raw material shortages due to geopolitical issues or supply disruptions.
• Manufacturing delays stemming from capacity limitations or regulatory compliance issues.
• Logistical bottlenecks compromising cold chain integrity.

Manufacturers mitigate these risks through diversified supplier bases, strategic inventory management, and regional manufacturing hubs.

Conclusion

Ensuring a stable and compliant supply chain for AVIANE-21 involves a layered network of specialized suppliers across APIs, formulation, packaging, and distribution. Leading organizations like Fujifilm Diosynth Biotechnologies, Samsung Biologics, WuXi Biologics, Lonza, and others play pivotal roles. These alliances enable scalable manufacturing, meet regulatory standards, and support global distribution. The continuous evaluation of supplier performance, adherence to quality standards, and strategic diversification remain vital for the successful commercialization and market penetration of AVIANE-21.

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Key Takeaways

• Diverse supplier ecosystem: Collaboration with multiple API producers, CMOs, and logistics firms minimizes supply chain vulnerabilities.
• Regulatory compliance: Suppliers must demonstrate GMP adherence, quality assurance, and traceability to meet global standards.
• Strategic partnerships: Long-term alliances enhance manufacturing capacity and innovation for AVIANE-21.
• Supply chain risk management: Diversification and regional manufacturing hubs mitigate geopolitical and logistical risks.
• Future trends: Increased integration of digital supply chain solutions and blockchain for traceability will boost transparency and efficiency.

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Frequently Asked Questions

Q1: What are the main challenges suppliers face in producing AVIANE-21?
A: Challenges include maintaining GMP standards, scaling biologic production, ensuring raw material quality, and managing complex logistics, especially given the sensitive nature of biologics.

Q2: How do regulatory agencies influence AVIANE-21's supply chain?
A: Agencies enforce strict GMP compliance, require thorough validation, and conduct audits, ensuring suppliers meet safety and quality standards essential for global distribution.

Q3: Are there regional differences in AVIANE-21 suppliers?
A: Yes, suppliers are distributed globally, including North America, Europe, and Asia, to ensure localized production, regulatory compliance, and supply redundancy.

Q4: What role do contract manufacturing organizations (CMOs) play in the AVIANE-21 supply chain?
A: CMOs handle large-scale formulation, fill-finish, and packaging operations, enabling flexible scaling and ensuring manufacturing continuity.

Q5: How is supply chain resilience being enhanced for AVIANE-21?
A: By diversifying supplier bases, establishing regional manufacturing hubs, and leveraging digital logistics solutions, companies aim to reduce dependencies and mitigate disruptions.

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References:

[1] Pharmaceutical Technology. "Biologics API Manufacturing." 2022.
[2] Regulatory Affairs Professionals Society. "GMP Standards for Biologics." 2023.
[3] McKinsey & Company. "Supply Chain Strategies for Biologics." 2022.