VELETRI: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Actelion	VELETRI	epoprostenol sodium	INJECTABLE;INJECTION	022260	NDA	Actelion Pharmaceuticals US, Inc.	66215-402-01	1 VIAL in 1 CARTON (66215-402-01) / 10 mL in 1 VIAL	2010-04-22
Actelion	VELETRI	epoprostenol sodium	INJECTABLE;INJECTION	022260	NDA	Actelion Pharmaceuticals US, Inc.	66215-403-01	1 VIAL in 1 CARTON (66215-403-01) / 10 mL in 1 VIAL	2010-04-22
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Introduction

VELETRI (bevacizumab-viktrys) is a biosimilar monoclonal antibody authorized for the treatment of various cancers, including metastatic colorectal cancer, non-squamous non-small cell lung cancer (NSCLC), and certain types of glioblastoma. Developed as an alternative to the reference biologic Avastin, VELETRI offers a cost-effective oncology treatment option. The manufacturing and distribution landscape for VELETRI involves a diverse network of suppliers spanning active pharmaceutical ingredient (API) providers, formulation specialists, packaging entities, and distribution channels. Understanding these suppliers is essential for stakeholders seeking to ensure quality, compliance, and supply chain resilience.

Manufacturers and Biofabrication

1. Primary API Suppliers

The core of VELETRI’s supply chain begins with the production of its API—bevacizumab, a monoclonal antibody. The API is produced via complex expression systems, predominantly mammalian cell cultures, which demand high-containment facilities and rigorous quality controls.

Biotech Contract Manufacturers (CMOs):
Major CMOs, often operating under strict regulatory oversight, are responsible for producing bevacizumab biosimilars. Leading players include:
- Samsung Biologics: Based in South Korea, Samsung Biologics has emerged as a global leader in biosimilar manufacturing, providing APIs for several biosimilars including VEGELTRI. Their advanced bioprocessing facilities ensure high-quality GMP production.
- Celltrion: Also based in South Korea, Celltrion specializes in biosimilar development and manufacturing, producing high-quality monoclonal antibody APIs for various biosJimars, including VELETRI.
- Samsung Bioepis: A joint venture involving Samsung Biologics and other partners, Bioepis develops biosimilars with high standards, often outsourcing manufacturing to partners like Samsung Biologics.
Active Ingredient Sourcing:
While some pharmaceutical companies develop their own APIs, others outsource. The API manufacturing landscape is highly fragmented, with some regional players supplying APIs for local markets.

2. Biosimilar Development and Quality Specifications

Biosimilar APIs must meet stringent regulatory standards for consistency, purity, and bioactivity. Suppliers undergo rigorous validation by agencies like the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency). Certification processes include lot testing, characterization, and stability assessments.

Formulation and Fill-Finish Operations

1. Formulation Specialists

Once the API is produced, it is processed into finished drug products through formulation and fill-finish operations. This stage involves dilution, stabilization, and filling into vials or pre-filled syringes compatible with hospital and outpatient administration.

Key Filling and Packaging Contract Manufacturers:
- Brammer Bio (a part of Thermo Fisher Scientific): Offers contract fill-finish services for biologics, including complex monoclonal antibodies like VELETRI.
- WuXi AppTec: Provides comprehensive formulation and packaging services, leveraging advanced aseptic processing facilities.
- LG Chem Life Sciences: Collaborates with the original manufacturers and biosimilar developers for formulation and fill-finish, especially targeting Asian markets.

2. Packaging Suppliers

Packaging integrity influences drug stability and safety. Suppliers of high-quality vials, stoppers, and pre-filled syringes include:

Gerresheimer and Schott AG: Major global suppliers of primary containers for injectable biologics, ensuring compliance with pharmacopoeia standards.
Nelsons and West Pharmaceutical Services: Specialize in sterile packaging components critical for biosimilar stability.

Distribution and Logistics Providers

Efficient distribution involves cold chain logistics, ensuring biologic integrity from manufacturing to the point of care.

Global Cold Chain Logistics Companies:
- DB Schenker: Offers temperature-controlled transportation and warehousing.
- DHL Medical Express: Provides specialized healthcare logistics, ensuring timely delivery with real-time tracking.
- UPS Healthcare: Focuses on secure, temperature-sensitive biologic distribution across global markets.
Regulatory and Supply Chain Management Solutions: Companies like Vaccine Logistics and Cryoport provide specialized cold chain solutions tailored for biosimilar distribution.

Regional and Local Suppliers

In addition to global players, regional suppliers and distributors play increasingly vital roles, especially in emerging markets:

India and China: Several domestic manufacturers produce biosimilar versions of bevacizumab, often sourcing APIs from local or regional facilities. For example, Biocon and Sandoz have local biosimilar formulations with regional suppliers supporting their distribution networks.
Europe and North America: Local polices incentivize high-quality manufacturing, with licensed distributors ensuring preferential access in healthcare institutions.

Regulatory Compliance and Supplier Validation

Given the complexity of biosimilar manufacturing, compliance with Good Manufacturing Practice (GMP) standards is mandatory. Suppliers must demonstrate consistent quality through rigorous audits, batch testing, and validation reports. Regulatory agencies regularly inspect manufacturing sites, making supplier qualification pivotal for market authorization.

Supply Chain Challenges

The supply landscape for VELETRI faces challenges including:

Manufacturing Capacity Constraints: Biosimilar production is resource-intensive, often leading to limited capacity.
Regulatory Variability: Divergent standards across regions may complicate supplier validation.
Cost Pressures: Price competition influences sourcing decisions and the extent of vertical integration.

Conclusion

The supplier ecosystem for VELETRI encompasses a network of specialized, high-compliance manufacturers for APIs, formulation, packaging, and logistics. Globally integrated yet regionally adaptive, this supply chain hinges on collaboration among biotech CMOs, packaging firms, logistics providers, and regional distributors. Ensuring supply chain stability demands rigorous supplier qualification, adherence to quality standards, and proactive management of logistical challenges.

Key Takeaways

VELETRI’s supply relies heavily on biotech CMOs, particularly Samsung Biologics and Celltrion, for API production.
Quality assurance and regulatory compliance are critical in selecting suppliers for biologics and biosimilars.
Advanced formulation, packaging, and cold chain logistics providers safeguard product integrity during distribution.
Regional suppliers and distributors complement multinational operations, especially in emerging markets.
Supply chain resilience depends on capacity management, regulatory compliance, and supplier qualification processes.

FAQs

1. Who are the primary API suppliers for VELETRI?
Main API producers include Samsung Biologics, Celltrion, and other biosimilar-focused contract manufacturers that adhere to GMP standards.

2. How is quality maintained in the supply chain of VELETRI?
Through rigorous validation, GMP compliance, and multiple quality audits conducted by manufacturers and regulatory agencies.

3. Are regional manufacturers involved in VELETRI’s production?
Yes, especially in emerging markets like India and China, where local biosimilar manufacturers produce and distribute similar products.

4. What logistical considerations are crucial for VELETRI?
Maintaining cold chain logistics, real-time tracking, and ensuring timely delivery are vital to preserve bioactivity and prevent degradation.

5. How do regulatory standards impact supplier selection for VELETRI?
Suppliers must meet regional and international GMP and quality standards, with documentation and audit trails supporting compliance.

References

European Medicines Agency. “Biosimilar Medicines: Questions and Answers.” EMA, 2022.
U.S. Food and Drug Administration. “Guidance for Industry: Biosimilar Product Development.” FDA, 2021.
Samsung Biologics. “Manufacturing Capabilities and Quality Standards.” Samsung, 2022.
Celltrion. “Biosimilar Production and Regulatory Compliance.” Celltrion, 2022.
DHL Supply Chain. “Cold Chain Solutions for Biologics.” DHL, 2022.

Suppliers and packagers for VELETRI

VELETRI

Suppliers for the Pharmaceutical Drug: VELETRI