AVITA: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mylan Pharms Inc	AVITA	tretinoin	CREAM;TOPICAL	020404	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	0472-0117-20	1 TUBE in 1 CARTON (0472-0117-20) / 20 g in 1 TUBE	1998-04-20
Mylan Pharms Inc	AVITA	tretinoin	CREAM;TOPICAL	020404	NDA AUTHORIZED GENERIC	Actavis Pharma, Inc.	0472-0117-45	1 TUBE in 1 CARTON (0472-0117-45) / 45 g in 1 TUBE	1998-04-20
Mylan Pharms Inc	AVITA	tretinoin	CREAM;TOPICAL	020404	NDA AUTHORIZED GENERIC	A-S Medication Solutions	50090-0651-0	1 TUBE in 1 CARTON (50090-0651-0) / 20 g in 1 TUBE	1998-04-20
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape features numerous specialty drugs, among which AVITA Therapeutics Inc., notable for its flagship product, RECELL® (autologous cellular suspension), has garnered significant attention. As a pioneering regenerative medical device, AVITA’s success hinges heavily on its supply chain integrity, encompassing raw material procurement, manufacturing operations, and distribution networks. Effective supplier management ensures product quality, regulatory compliance, and timely market access—critical factors for patient health outcomes and corporate performance.

Overview of AVITA and RECELL®

AVITA Therapeutics focuses on autologous cell therapies designed to treat thermal burns, acute wounds, and other dermatological conditions. RECELL®, approved by the U.S. Food and Drug Administration (FDA) in 2018, utilizes a proprietary process to harvest a patient’s skin cells, expanding them into a suspension that accelerates wound healing. The commercialization of RECELL® necessitates a complex supply chain involving multiple suppliers for raw materials, bioprocessing components, and device manufacturing.

Key Suppliers in AVITA’s Supply Chain

1. Raw Material Suppliers

The core raw material for RECELL® is the patient's own skin tissue, which is processed at AVITA’s manufacturing sites. However, the procurement of ancillary raw materials—such as reagents, enzymes, and culture media—relies on specialized suppliers.

Enzymes and Reagents: Critical for tissue digestion and cell processing, AVITA sources enzymes such as collagenases and proteases from established biotech suppliers like Worthington Biochemical or Sigma-Aldrich. These vendors provide high-quality, GMP-compliant enzymes essential for cell viability and process consistency.
Culture Media and Supplements: Suppliers like Gibco (Thermo Fisher Scientific) and Lonza offer cell culture media and growth factors necessary for expanding keratinocytes and fibroblasts. Their products must meet stringent quality standards to ensure reproducible results.
Consumables: Consumables such as sterile scalpels, vials, and filtration units originate from suppliers like Corning or Nunc, providing sterile, GMP-grade equipment crucial for bioprocessing.

2. Bioprocessing Equipment and Device Suppliers

The manufacturing process involves sophisticated equipment for tissue digestion, cell separation, and suspension formulation.

Incubators and Bioreactors: Suppliers like Eppendorf or Sartorius supply bioreactors and incubators with precise temperature, humidity, and CO₂ control, ensuring optimal cell growth conditions.
Automated Processing Systems: AVITA leverages modular, automated systems—possibly from suppliers such as GE Healthcare or CellGenix—to standardize cell preparation and minimize contamination risks.

3. Manufacturing and Contract Manufacturing Organizations (CMOs)

Although AVITA maintains its own manufacturing facilities, it may also partner with CMOs to scale production.

Notably, Fennec Pharmaceuticals and other specialized CMOs with GMP-certified facilities have supported AVITA's expansion, especially for global market entry. These agreements allow for flexibility, scalability, and regulatory compliance.

4. Distribution and Logistics Partners

Timely delivery of the finished product is vital due to its autologous nature, limiting storage durations.

Cold Chain Logistics: AVITA partners with logistics providers such as DHL or FedEx Custom Critical for temperature-sensitive transportation, ensuring product integrity during transit.
Warehousing: Strategic partnerships with regional warehousing facilities facilitate rapid distribution, especially in international markets.

Supply Chain Challenges and Strategies

AVITA’s supply chain faces multiple challenges typical of advanced therapy medicinal products.

Raw Material Variability: Biological materials require rigorous sourcing and quality assurance. Collaborations with reputable suppliers that comply with GMP standards reduce variability and contamination risk.
Regulatory Compliance: Suppliers must adhere to evolving regulations, particularly as AVITA expands globally. Due diligence and supplier qualification processes are integral for maintaining compliance.
Scale-Up and Capacity Planning: As demand for RECELL® grows, AVITA must expand its supplier base and negotiate capacity commitments, including establishing dual sourcing arrangements to hedge against supply disruptions.
Supply Chain Transparency: Implementing digital traceability systems enhances oversight, enabling rapid identification and resolution of bottlenecks or issues.

Implications for Business Professionals

Understanding AVITA’s supplier landscape informs strategic decision-making for stakeholders in pharma, healthcare, and investment sectors.

Investment Decisions: Reliable supplier partnerships underpin product scalability; disruptions can impact revenues and patient access.
Supply Chain Risk Management: Diversification of suppliers, especially for critical raw materials, reduces dependence on single vendors and mitigates risks related to geopolitical issues, pandemics, or quality lapses.
Regulatory and Quality Assurance: Strategic supplier qualification aligns with regulatory expectations, ensuring product quality and patient safety.
Global Expansion Strategies: Suppliers with international GMP certifications facilitate AVITA’s entry into new markets, streamlining approval processes.

Key Takeaways

AVITA relies on a diversified supplier network encompassing biotech reagent providers, equipment vendors, CMOs, and logistics partners to maintain its supply chain integrity.
Strategic supplier partnerships ensure quality, scalability, and regulatory compliance, vital for the commercial success of RECELL®.
Supply chain resilience is achieved through dual sourcing, digital traceability, and proactive capacity planning.
Global expansion necessitates partnerships with internationally certified suppliers, enabling rapid market access.
Business professionals should monitor supplier performance, regulatory alignments, and geopolitical factors influencing AVITA’s supply chain to make informed strategic decisions.

FAQs

1. Who are the primary raw material suppliers for AVITA's RECELL®?
AVITA sources enzymes, culture media, and consumables from GMP-compliant biotech companies such as Sigma-Aldrich, Gibco (Thermo Fisher), and Lonza, ensuring high-quality material inputs for cell processing.

2. How does AVITA manage its supply chain risks?
The company employs dual sourcing strategies, maintains rigorous supplier qualification, leverages digital traceability systems, and collaborates with CMOs to ensure continuous supply and regulatory compliance.

3. What logistical challenges does AVITA face in delivering autologous cell therapies?
The autologous nature requires precise cold chain management, rapid transportation, and regional warehousing to preserve cell viability and reduce delivery times.

4. Are there opportunities for new suppliers to partner with AVITA?
Yes. As AVITA expands, it seeks reliable suppliers specializing in GMP-grade bioprocessing reagents, manufacturing equipment, and logistics services to support scaled production and international market entry.

5. How does supplier quality impact AVITA's regulatory approvals?
High-quality, GMP-compliant suppliers reduce contamination, variability, and non-compliance risks, facilitating smoother regulatory review processes and ensuring consistent product safety and efficacy.

References

[1] AVITA Therapeutics Inc. — Official Website, Product information.
[2] U.S. Food and Drug Administration (FDA). RECELL® (autologous cell suspension) approval documentation.
[3] BioPharm International. "Managing Supply Chain Risks for Advanced Therapies."
[4] PharmaGMP. "Supplier Qualification and Quality Assurance in Cell Therapy Manufacturing."
[5] Logistics Management. "Cold Chain Logistics for Cell and Gene Therapies."

Suppliers and packagers for AVITA

AVITA

Suppliers for the Pharmaceutical Drug: AVITA