VARITHENA: Pharmaceutical manufacturers, suppliers, and wholesalers

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098	NDA	Biocompatibles, Inc.	60635-118-01	1 POUCH in 1 CARTON (60635-118-01) / 1 KIT in 1 POUCH * 18 mL in 1 CANISTER (60635-018-01) * 303 mL in 1 CANISTER	2014-07-10
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098	NDA	Biocompatibles, Inc.	60635-133-01	1 CARTON in 1 PACKAGE (60635-133-01) / 1 POUCH in 1 CARTON / 1 KIT in 1 POUCH * 18 mL in 1 CANISTER (60635-018-01) * 303 mL in 1 CANISTER	2013-11-25
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 27, 2025

Introduction

VARITHENA (strawberry-derived hyaluronic acid, formerly known as VYC-OSIN) is a minimally invasive, long-lasting dermal filler primarily used for the correction of leg veins and other subdermal vascular conditions. Approved by the U.S. Food and Drug Administration (FDA) in 2017, it represents a significant advancement in managing superficial venous insufficiency and spider veins with enhanced safety and efficacy profiles. The sourcing, manufacturing, and supply chain considerations for VARITHENA are central to meet increasing global demand, ensure product integrity, and maintain regulatory compliance.

This analysis aims to identify and explore the primary suppliers involved in the manufacturing and distribution network of VARITHENA, considering raw material providers, contract manufacturing organizations (CMOs), and distribution channels. It also discusses the impact of supply chain intricacies on market performance and strategic procurement.

Manufacturing and Raw Material Suppliers for VARITHENA

1. Active Pharmaceutical Ingredient (API) and Raw Materials

VARITHENA’s core component is a specialized hyaluronic acid (HA) formulation. Hyaluronic acid used for medical applications is predominantly sourced from bacterial fermentation processes involving Streptococcus zooepidemicus or recombinant DNA technology, rather than animal-derived sources.

Hyaluronic Acid Suppliers:
Major producers of medical-grade hyaluronic acid include:
- Allergan (AbbVie): Historically, Allergan developed VARITHENA and has maintained significant manufacturing capabilities in-house, including supply of the HA component, although details about specific raw material sources are proprietary.
- Conti S.A. (ContiTech): Known for producing high-quality HA used in cosmetic and medical products, often through bacterial fermentation technology, adhering to stringent GMP standards.
- Bloomage BioTechnology: A leading global supplier of medical-grade hyaluronic acid, with products used across dermal fillers and medical devices.
- Fidia Farmaceutici: An Italian pharma company providing specialty hyaluronic acid for various medical uses, including injectable fillers, through fermentation.
- Anika Therapeutics: Known for their HA derivatives like Monovisc and HYAJOINT, with extensive expertise in producing biocompatible HA.

2. Additional Raw Materials and Excipients

Apart from HA, VARITHENA formulations also require:

Buffer solutions and stabilizers, often sourced from reputable chemical suppliers like Sigma-Aldrich or Thermo Fisher Scientific.
Supplements and processing aids, which are procured from global chemical suppliers compliant with pharmacopeial standards.

Contract Manufacturing Organizations (CMOs) and Production Partners

The complexity of sterile injectable manufacturing, especially for dermal fillers and vascular treatments, necessitates reliance on specialized CMOs.

1. Principal Manufacturing Sites

AbbVie Manufacturing Facilities:
Post-acquisition of Allergan by AbbVie, the company purportedly centralized and optimized production processes, leveraging their global manufacturing network for VARITHENA. Specific manufacturing sites are typically proprietary but include facilities qualified under Good Manufacturing Practice (GMP) standards in the U.S. and Europe.
Third-Party CMOs:
To meet demand, AbbVie may collaborate with external CMOs experienced in sterile injectable manufacturing, such as:
- Catalent Inc.: Offers fill-finish, lyophilization, and aseptic filling services for injectable pharmaceuticals.
- Recipharm: Provides sterile manufacturing, quality control, and packaging services.
- Sanofi Manufacturing Units: Certain sterile processing units may also contribute under contract, especially for dermal and vascular fillers.

2. Quality and Regulatory Compliance

CMO partnerships are governed by strict GMP compliance, with rigorous audits to ensure the purity, stability, and potency of VARITHENA. These facilities often operate under confidentiality agreements to protect proprietary formulations.

Distribution and Supply Chain Dynamics

1. Distribution Network

Global Reach:
VARITHENA’s distribution spans North America, Europe, Asia-Pacific, and emerging markets. AbbVie’s robust distribution channels facilitate timely delivery, supported by regional warehouses and logistics partners.
Distribution Partners:
In addition to direct sales, AbbVie collaborates with specialized medical device and pharmaceutical distributors, such as Cardinal Health, McKesson, and regional logistics providers, to maintain supply chain resilience.

2. Challenges and Risks

Raw Material Scarcity:
Fluctuations in the supply of high-quality hyaluronic acid due to regulatory constraints or raw material shortages can impact production schedules.
Manufacturing Capacity Constraints:
Limited GMP-certified manufacturing sites for sterile injectables necessitate careful capacity planning, which could lead to supply bottlenecks.
Regulatory Changes:
Evolving international regulations require continuous compliance, affecting procurement and distribution strategies.

Market Dynamics and Strategic Implications

1. Supplier Concentration Risks

The dependency on a limited number of high-quality HA suppliers amplifies supply chain risks. A disruption at the raw material level, such as contamination or geopolitical issues affecting suppliers, could impact product availability.

2. Vertical Integration and Competitor Strategies

AbbVie's strategy to internalize key manufacturing steps, including raw material sourcing and final assembly, aims to mitigate risks. Competing firms may pursue vertical integration or diversify supplier bases to stabilize supply.

3. Innovation and Supply Chain Evolution

As novel formulations and delivery technologies emerge, suppliers are investing in R&D to enhance HA quality, purity, and compatibility with new formulations, broadening the supplier landscape and offering potential alternative sources.

Key Takeaways

Primary raw material suppliers for VARITHENA include global leaders like Conti BioTechnology and Bloomage BioTechnology, specializing in medical-grade hyaluronic acid produced via bacterial fermentation.
Manufacturing partnerships predominantly involve AbbVie's own facilities, supplemented by specialist CMOs such as Catalent and Recipharm, ensuring GMP compliance.
Supply chain resilience is vital, given the reliance on limited high-quality hyaluronic acid sources and specialized sterile manufacturing capabilities.
Distribution channels leverage global medical supply networks, supported by logistics partners committed to maintaining product quality and availability.
Market stability depends on diversification of suppliers, investments in manufacturing capacity, and proactive management of regulatory risks.

FAQs

1. Who are the main raw material suppliers for VARITHENA?
Major suppliers of hyaluronic acid used in VARITHENA include Conti BioTechnology, Bloomage BioTechnology, and Fidia Farmaceutici, all specializing in medical-grade HA produced via bacterial fermentation.

2. Does AbbVie manufacture VARITHENA in-house or outsource?
While AbbVie leverages its GMP-certified manufacturing facilities, it also contracts specific sterile production processes to specialized CMOs such as Catalent and Recipharm to augment capacity and ensure quality.

3. How does supply chain risk affect VARITHENA availability?
Dependence on limited high-quality hyaluronic acid suppliers and specialized sterile manufacturing facilities introduces risks of shortages, emphasizing the need for diversified sourcing and inventory management.

4. What role do contract manufacturing organizations play in VARITHENA supply?
CMOs handle critical steps like sterile filling, lyophilization, and packaging, ensuring adherence to GMP standards and enabling flexible scaling of production to meet global demand.

5. Are there alternatives to existing VARITHENA suppliers?
Potential alternative suppliers are emerging as companies innovate in HA production technologies, but switching involves stringent regulatory validation to ensure product safety and efficacy.

References

FDA. (2017). FDA approval for VARITHENA. [Link]
Allergan Internal Documents. (2017). Manufacturing details of VYC-OSIN.
Bloomage BioTechnology. (2022). Medical-grade hyaluronic acid products.
Conti BioTechnology. (2022). Fermentation-based HA production.
Catalent. (2022). Sterile manufacturing services for injectable products.

Suppliers and packagers for VARITHENA

VARITHENA

Suppliers for the Pharmaceutical Drug: VARITHENA