Suppliers and packagers for vibativ

vibativ

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110	NDA	Cumberland Pharmaceuticals Inc.	66220-315-11	1 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-11) / 50 mL in 1 VIAL, SINGLE-DOSE	2021-01-01
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110	NDA	Cumberland Pharmaceuticals Inc.	66220-315-22	12 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-22) / 50 mL in 1 VIAL, SINGLE-DOSE	2021-01-01
Cumberland	VIBATIV	telavancin hydrochloride	POWDER;INTRAVENOUS	022110	NDA	Cumberland Pharmaceuticals Inc.	66220-315-44	4 VIAL, SINGLE-DOSE in 1 CARTON (66220-315-44) / 50 mL in 1 VIAL, SINGLE-DOSE	2021-01-01

Suppliers for the Pharmaceutical Drug: VIBATIV

Last updated: August 1, 2025

Introduction

VIBATIV (oritavancin) is a potent antibiotic used to treat acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Approved by the FDA in 2014, VIBATIV is a semi-synthetic lipoglycopeptide with a complex manufacturing process, necessitating a robust and specialized supply chain. For pharmaceutical companies, healthcare providers, and distributors, understanding VIBATIV’s suppliers is crucial for securing consistent access, ensuring quality, and navigating regulatory landscapes.

This analysis explores the key suppliers involved in the production, raw materials sourcing, and distribution of VIBATIV, emphasizing the current market dynamics, manufacturing considerations, and competitive landscape.

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Manufacturers of VIBATIV

1. The Selling/Marketing Partner: Merck & Co.

Merck & Co. holds exclusive rights to market and sell VIBATIV globally. The company is responsible for manufacturing, distribution, and regulatory compliance. While Merck does not publicly disclose all manufacturing partners, evidence suggests that the production of VIBATIV involves partnerships with specialized pharmaceutical manufacturers and CDMOs (Contract Development and Manufacturing Organizations).

2. Contract Manufacturing Organizations (CMOs)

Given the complexity of VIBATIV’s synthesis, many pharmaceutical firms outsource manufacturing to CMOs specializing in complex peptide synthesis and lipoglycopeptide production. The following are pivotal players:

• Lonza Group: Known for producing complex biologics and peptides, Lonza has the capacity to manufacture drugs like VIBATIV at scale, adhering to cGMP standards. Their facilities in Switzerland and the United States are equipped for sterile production, purification, and quality control.

• Boehringer Ingelheim: With a focus on peptides and complex molecules, Boehringer has the technological capability to manufacture lipoglycopeptides under strict quality parameters. Although not directly confirmed as a supplier for VIBATIV, their expertise aligns with the demands of such products.

• Samsung Biologics: A leading CMO for biologics and complex small molecules, Samsung’s expansive facilities in South Korea may serve as manufacturing partners for specialty antibiotics like VIBATIV, especially in supply chains targeting Asia.

3. Raw Material Suppliers

VIBATIV’s synthesis involves highly specialized raw materials, including complex amino acids, lipids, and fermentation substrates. The key raw material suppliers are:

• BASF and Eastman Chemical: Suppliers of specialty chemicals like amino acids and lipids used in lipoglycopeptide synthesis. These materials must meet stringent pharmacopoeial standards.

• Sigma-Aldrich (Merck Group): Provides reagents, solvents, and intermediates required for peptide synthesis. Their quality assurance processes align with pharmaceutical manufacturing standards.

• Lonza and Cambrex: Supply of peptide synthesis intermediates and amino acids, crucial for producing the active pharmaceutical ingredient (API).

4. Active Pharmaceutical Ingredient (API) Production

VIBATIV’s API, oritavancin, is synthesized via complex fermentation and chemical modification processes. Merck’s internal manufacturing facilities in the United States likely produce the API, potentially utilizing partnerships with specialized fermentation facilities and chemical synthesis plants.

While specific supplier details are proprietary, the critical nature of API production necessitates sourcing from facilities compliant with cGMP and possessing advanced bioreactor and purification technologies.

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Distribution and Supply Chain Post-Manufacturing

Once manufactured, VIBATIV is distributed through a controlled supply chain, primarily managed by Merck. This involves:

• Global Distribution Centers: Located in North America, Europe, and Asia, these centers maintain inventory and ensure regulatory compliance tailored to regional markets.

• Specialty Pharmacies and Hospitals: VIBATIV’s use in hospital settings requires distribution through specialized pharmacy networks, with strict temperature controls and traceability.

• Third-party Distributors: For regions outside Merck’s direct reach, authorized third-party distributors facilitate supply, often requiring formal agreements and compliance with international trade laws.

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Market Dynamics and Supply Chain Challenges

The limited number of companies capable of producing lipoglycopeptides like VIBATIV constrains market competition but elevates supply chain fragility. Manufacturing complexities, including the need for high-purity raw materials and stringent regulatory standards, mean that disruptions at any link—raw material shortages, regulatory delays, or manufacturing issues—can impact supply.

Regulatory oversight by authorities like the FDA ensures product safety but may also contribute to supply constraints during renewal, inspection, or capacity expansion periods. Additionally, the niche market size limits incentives for multiple large-scale manufacturers, perpetuating reliance on a few key players.

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Emerging Trends and Future Outlook

• Vertical Integration: Merck’s potential investment in in-house manufacturing capacity could enhance supply security for VIBATIV, reducing dependence on third-party CMOs.

• Partnership Expansion: Collaborations with sustainable raw material suppliers could mitigate risks associated with raw material shortages or quality variability.

• Regional Manufacturing: Establishing regional manufacturing hubs in emerging markets may improve access and reduce lead times.

• Supply Chain Transparency: Blockchain and digital tracking technologies are increasingly adopted to enhance traceability, compliance, and reliability.

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Conclusion

VIBATIV’s supply chain hinges on a confluence of specialized manufacturers, raw material suppliers, and distribution partners, primarily orchestrated by Merck & Co. The complex synthesis and regulatory demands restrict the pool of capable suppliers, elevating the importance of strategic partnerships with organizations like Lonza, Sigma-Aldrich, and possibly Samsung Biologics.

For stakeholders in the pharmaceutical ecosystem, securing reliable supplier relationships, monitoring raw material markets, and anticipating manufacturing capacity expansions are essential for maintaining uninterrupted access to VIBATIV.

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Key Takeaways

• Merck & Co. is the primary market and supply chain orchestrator for VIBATIV, relying on CMOs like Lonza for manufacturing.
• Raw materials for VIBATIV, including amino acids and lipids, are sourced from specialized suppliers like BASF, Sigma-Aldrich, and Cambrex.
• Complex synthesis processes limit the number of capable manufacturers, creating potential vulnerabilities in supply.
• Regional manufacturing hubs and increased partnership with raw material suppliers could mitigate future supply risks.
• Continuous market monitoring and strategic supplier engagement are vital for stakeholders to ensure consistent access to VIBATIV.

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FAQs

1. Who are the key manufacturers involved in producing VIBATIV?
Merck & Co. is the exclusive marketer and likely the primary producer, outsourcing complex synthesis processes to contract manufacturing organizations such as Lonza and possibly Samsung Biologics, which specialize in biologics and complex peptides.

2. What raw materials are essential for VIBATIV production?
The synthesis requires specialty amino acids, lipids, and chemical reagents sourced from suppliers like BASF, Sigma-Aldrich, and Cambrex. These materials must meet high purity and compliance standards.

3. Are there alternative suppliers for VIBATIV?
Due to the complexity of synthesis and regulatory constraints, few companies possess the capabilities to produce VIBATIV's API. Market entry barriers limit alternative suppliers unless new manufacturing facilities are established.

4. How does supply chain complexity impact the availability of VIBATIV?
The intricate manufacturing process, dependence on specialized raw materials, and regulatory requirements increase vulnerability to supply disruptions, potentially affecting availability and pricing.

5. What future trends could influence VIBATIV’s supply chain?
Advances include potential in-house manufacturing expansion by Merck, regional production hubs, and adoption of digital traceability technologies, all aimed at enhancing supply security and efficiency.

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Sources

1. U.S. Food and Drug Administration. VIBATIV (oritavancin) prescribing information. 2014.
2. Merck & Co. Corporate website. VIBATIV overview.
3. Lonza Group. Manufacturing capabilities for complex peptides.
4. BASF and Sigma-Aldrich product catalogs. Specialty chemicals for pharmaceutical synthesis.
5. Market reports on lipoglycopeptides and specialty antibiotics manufacturing.