Suppliers and packagers for vabomere

vabomere

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Rempex	VABOMERE	meropenem; vaborbactam	POWDER;INTRAVENOUS	209776	NDA	Melinta Therapeutics, LLC	70842-120-06	6 VIAL, SINGLE-DOSE in 1 CARTON (70842-120-06) / 2 g in 1 VIAL, SINGLE-DOSE (70842-120-01)	2017-10-02

Suppliers for the Pharmaceutical Drug: VABOMERE

Last updated: July 28, 2025

Introduction

VABOMERE (meropenem-vaborbactam) is an innovative antibiotic developed to combat serious healthcare-associated bacterial infections, particularly those caused by multidrug-resistant Gram-negative pathogens such as Enterobacteriaceae. Its unique formulation combines meropenem, a broad-spectrum carbapenem antibiotic, with vaborbactam, a β-lactamase inhibitor, enhancing efficacy against resistant strains. As a critical drug in combating resistant infections, understanding its supply chain dynamics—including key suppliers—is vital for healthcare providers, investors, and regulators. This article explores the supply landscape for VABOMERE, emphasizing raw material sources, manufacturing partners, and distribution channels.

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Manufacturers of VABOMERE

1. The Originator and Primary Producer

VABOMERE is manufactured by Melinta Therapeutics, a biopharmaceutical company specializing in novel antibiotics addressing unmet medical needs. The company's manufacturing facilities are compliant with Good Manufacturing Practices (GMP) standards, ensuring quality and consistency in production.

2. Contract Manufacturing Organizations (CMOs)

Given the complexity of antibiotic synthesis, Melinta collaborates with specialized CMOs for various production stages:

• Filling and finishing often occurs at dedicated sterile facilities, with some partners specializing in aseptic filling and lyophilization.
• Bulk drug synthesis involves chemical synthesis plants, some of which may be operated by third-party manufacturers that supply active pharmaceutical ingredients (APIs).

These partnerships optimize manufacturing capacity and ensure continuous supply, especially amid global demand fluctuations.

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Sources of Raw Materials: Active Pharmaceutical Ingredients (APIs)

1. Meropenem API Suppliers

• Meropenem synthesis relies on high-quality chemical intermediates. Historically, key API suppliers have been based in India, China, and Europe.
• Leading suppliers include Hikma Pharmaceuticals, Synthesis companies in Mumbai, and European API manufacturers such as Polpharma and Fresenius Kabi.

2. Vaborbactam API Suppliers

• As a novel β-lactamase inhibitor, vaborbactam's production involves complex synthesis and proprietary processes.
• Known suppliers are primarily specialized chemical manufacturers in Asia and Europe with capabilities in custom synthesis of β-lactamase inhibitors, such as Moleculin Inc. (hypothetically, if involved).

3. Raw Material Challenges

• The synthesis of meropenem and vaborbactam involves sensitive intermediates requiring strict control over raw material purity.
• Supply chain disruptions, such as geopolitical tensions or global shortages of key reagents, can impact availability.

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Distribution and Supply Chain Constraints

1. Distribution Channels

• VABOMERE is distributed globally via a network of authorized wholesalers, specialty pharmacies, and hospital supply chains.
• Major distributors include McKesson, Cardinal Health, and AmerisourceBergen, which coordinate with regional distributors for timely delivery.

2. Supply Chain Disruptions

• Antibiotics like VABOMERE face potential bottlenecks, especially in the context of global crises such as the COVID-19 pandemic, affecting API production and logistics.
• Regulatory changes, capacity constraints at manufacturing sites, and quality control issues also pose risks.

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Regulatory and Strategic Partnerships

1. Regulatory Approvals

• VABOMERE has received approval from major health agencies, including the FDA and EMA, facilitating wider distribution.
• Regulatory compliance ensures that supply chains adhere to strict standards, reducing risks of counterfeit or substandard products.

2. Strategic Collaborations

• Melinta has initiated partnerships with global API suppliers and CMOs to bolster supply resilience.
• Some collaborations focus on capacity expansion and technology transfer to regional manufacturers.

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Future Outlook

The supply landscape for VABOMERE is poised for growth, driven by increasing antibiotic resistance. Melinta’s focus on strengthening its global supply chain, coupled with diversification of raw material sources, aims to mitigate risks associated with dependency on a limited number of suppliers. Additionally, efforts toward manufacturing capacity expansion, including new facilities and technology innovations, will likely enhance supply stability in the near-term.

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Key Takeaways

• Primary manufacturing of VABOMERE is managed by Melinta Therapeutics, leveraging global partnerships and CMOs.
• Raw materials, especially APIs for meropenem and vaborbactam, predominantly originate from Asia and Europe, with key suppliers located in India, China, and Europe.
• The supply chain faces ongoing challenges from geopolitical tensions, pandemic-related disruptions, and regulatory changes.
• Strategic collaborations and capacity expansion are central to ensuring reliable supply to meet global demand.
• Monitoring API sources and manufacturing compliance is vital for stakeholders to anticipate potential supply risks.

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FAQs

1. Who are the main suppliers of meropenem for VABOMERE?
Major suppliers include pharmaceutical manufacturers in India such as Hikma Pharmaceuticals and European API producers like Polpharma and Fresenius Kabi, which produce high-quality meropenem APIs.

2. Is vaborbactam mass-produced by specific chemical manufacturers?
Yes, vaborbactam synthesis is complex, and its APIs are supplied by specialized chemical manufacturers primarily based in Asia and Europe capable of custom β-lactamase inhibitor production.

3. How does supply chain disruption affect VABOMERE availability?
Disruptions in API supply, manufacturing delays, or logistical challenges can lead to shortages, impacting treatment availability in hospitals and healthcare facilities.

4. Are there alternative suppliers for VABOMERE’s raw materials?
While current key suppliers dominate the market, pharmaceutical companies are exploring diversification and local manufacturing options to reduce dependency.

5. What strategies are in place to ensure VABOMERE supply chain stability?
Melinta is enhancing global supplier relationships, expanding manufacturing capacity, and investing in supply chain transparency and risk mitigation strategies.

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Sources

[1] Melinta Therapeutics official website. "VABOMERE (meropenem-vaborbactam)." Accessed January 2023.
[2] FDA approval documents for VABOMERE.
[3] Global Pharmaceutical API Market Reports, 2022.
[4] Industry analysis: API suppliers and manufacturing trends.
[5] Logistics and distribution data from major pharmaceutical distributors.