Suppliers and packagers for generic pharmaceutical drug: MEROPENEM; VABORBACTAM

MEROPENEM; VABORBACTAM

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 Drugs: Meropenem and Vaborbactam

Last updated: July 31, 2025

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Introduction

In the global pharmaceutical landscape, robust supply chains are vital for ensuring the availability of critical antibiotics such as Meropenem and Vaborbactam. These drugs play a pivotal role in combating multidrug-resistant bacterial infections, notably carbapenem-resistant Enterobacteriaceae (CRE). Understanding the key suppliers of these agents, their market dynamics, and strategic manufacturing partnerships is essential for stakeholders ranging from healthcare providers to policymakers. This article explores the primary suppliers for Meropenem and Vaborbactam, their manufacturing capabilities, and the strategic implications for the pharmaceutical supply chain.

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Overview of Meropenem and Vaborbactam

Meropenem is a broad-spectrum carbapenem antibiotic, first introduced in the late 1990s, manufactured by top pharmaceutical players and used extensively in hospital settings worldwide. Its efficacy against severe bacterial infections, including meningitis, pneumonia, and sepsis, makes it a staple in antimicrobial therapy.

Vaborbactam is a β-lactamase inhibitor that enhances the activity of β-lactam antibiotics like Meropenem, especially against resistant strains producing KPC (Klebsiella pneumoniae carbapenemase). Approved by the U.S. Food and Drug Administration (FDA) in 2017 under the brand name Vabomere (by Melinta Therapeutics), Vaborbactam, when combined with Meropenem, addresses critical unmet needs in drug-resistant infections.

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Major Suppliers and Manufacturing Dinamics

1. Meropenem Supplies

a. Pharmaceutical Manufacturers

• Pfizer Inc.: As the originator of Meropenem (marketed as Merrem), Pfizer remains a leading global supplier. Pfizer’s manufacturing facilities ensure a consistent global supply, supported by its extensive global footprint and proven supply chain resilience.

• Sandoz (Novartis Group): Sandoz produces generic versions of Meropenem, contributing significantly to affordability and access, particularly in emerging markets. Their manufacturing plants are strategically located in Europe and Asia, leveraging advanced biotechnology facilities.

• North China Pharmaceutical Group Corporation (North China Pharma): Active in the Chinese market, providing locally manufactured Meropenem, primarily for domestic use and regional export.

• Other Generics Players: Companies like Sun Pharma, Glenmark, and Aurobindo Pharma also produce generic Meropenem, enlarging the supply base and increasing market competition.

b. Manufacturing Challenges and Patent Landscape

• Pfizer holds patents on Meropenem until their expiration, after which generics flooded the market.

• Production complexities involve complex chemical synthesis and stringent quality control among sterile injectable antibiotics, demanding high-level GMP compliance.

• Supply chain disruptions can occur due to geopolitical issues, raw material shortages, or manufacturing capacity constraints, emphasizing the importance of diversified suppliers.

2. Vaborbactam Supplies

a. Proprietary Production

• Melinta Therapeutics: With FDA approval for Vabomere, Melinta was the primary supplier for Vaborbactam at launch. Their manufacturing facilities in the United States produce Vaborbactam under strict FDA guidelines.

b. Licensing and Partnerships

• While Melinta is the original producer, strategic licensing agreements may allow other API manufacturers to produce Vaborbactam. These partnerships enhance supply security and reduce dependence on a single source.

• The synthesis of Vaborbactam involves complex chemical processes with multi-step synthesis routes, which limit the number of qualified suppliers capable of scale-up.

c. Emerging Suppliers

• There is an increasing interest from API manufacturers in producing Vaborbactam, especially as demand for carbapenemase inhibitors grows with rising antimicrobial resistance globally. Potential suppliers include mid-sized chemical companies capable of complex β-lactamase inhibitor synthesis.

d. Supply Chain Considerations

• Quality assurance, regulatory approvals, and capacity constraints shape the availability of Vaborbactam. Strategic stockpiling and diversified sourcing among qualified manufacturers mitigate supply risks.

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Strategic Factors Influencing Supplier Dynamics

• Intellectual property (IP) landscape: Patents influence licensing agreements and market entry for generics, shaping supply options.

• Manufacturing complexity: Both Meropenem and Vaborbactam require sophisticated synthesis and sterile manufacturing capabilities, narrowing the pool of reliable suppliers.

• Regulatory environment: Approvals from agencies such as FDA, EMA, and NMPA impact supplier legitimacy and capacity to export.

• Supply chain resilience: geopolitical tensions, pandemic disruptions, and raw material shortages (e.g., key intermediates) can impact supply continuity.

• Market competition: Generics chiefly drive price competition post-patent expiry, expanding access but requiring careful management of manufacturing quality.

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Emerging Trends and Future Outlook

• The global imperative to address antimicrobial resistance (AMR) fuels investments in manufacturing capacity for both Meropenem and Vaborbactam. Collaborations between pharmaceutical companies and API producers are increasingly common to secure supply chains.

• Biotech advancements facilitate the production of complex β-lactamase inhibitors like Vaborbactam, potentially broadening the supplier base.

• Governments and international organizations emphasizing antibiotic stewardship and supply security stimulate initiatives for strategic stockpiling and multi-supplier sourcing.

• Patent expirations and the expiration of data exclusivity rights will likely expand the landscape of manufacturers, particularly for Meropenem generic formulations.

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Key Takeaways

• Pfizer remains the primary supplier of Meropenem globally, with significant manufacturing capacity to meet demand.

• Generic manufacturers such as Sandoz, Sun Pharma, and others contribute notably to the supply of Meropenem, especially in emerging markets.

• Vaborbactam production centers around Melinta Therapeutics, with potential emerging suppliers seeking market entry as demand for carbapenemase inhibitors climbs.

• Supply chain resilience relies on diversified sourcing, advanced manufacturing capabilities, and regulatory compliance.

• Future growth hinges on antimicrobial stewardship policies, patent landscapes, and technological innovations in complex molecule synthesis.

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FAQs

1. Who are the leading manufacturers of Meropenem globally?
Pfizer remains the sole originator and a major supplier. Several generics producers, including Sandoz, Sun Pharma, and Aurobindo, manufacture Meropenem, especially after patent expiry, increasing access and supply diversity.

2. Is Vaborbactam widely produced outside the United States?
Currently, Vaborbactam is primarily produced by Melinta Therapeutics in the US. However, with increasing global demand, other API manufacturers are exploring partnerships to expand production.

3. What factors could disrupt the supply of Meropenem and Vaborbactam?
Disruptions may stem from raw material shortages, manufacturing capacity constraints, geopolitical issues, and regulatory hurdles. The complexity of synthesis adds further supply-chain vulnerabilities.

4. How does patent status influence the supply chain for these drugs?
Patent protection limits generic entry; once patents expire, numerous manufacturers can produce low-cost generics, stabilizing supply and reducing prices. Patents on key formulations and combinations affect market dynamics.

5. Are there new entrants in the Vaborbactam market?
While currently limited to licensed producers like Melinta, emerging biotech firms and chemical companies are investigating Vaborbactam synthesis, potentially increasing supply options in future years.

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References

1. [1] U.S. Food and Drug Administration. (2017). Vabomere (meropenem and vaborbactam) prescribing information.
2. [2] Pfizer Inc. Annual Reports and pipeline data.
3. [3] Sandoz corporate website: product portfolio and manufacturing capabilities.
4. [4] Melinta Therapeutics. Vabomere manufacturer details and production overview.
5. [5] World Health Organization. Antimicrobial resistance global action plan.

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Summary

Securing a stable supply chain for Meropenem and Vaborbactam requires continuous awareness of manufacturing capacities, regulatory landscapes, and geopolitical influences. Pfizer’s dominance in Meropenem ensures consistent supply, complemented by a growing cadre of generics. The specialized synthesis of Vaborbactam constrains its production to a limited number of high-capacity manufacturers, though future shifts may expand the supplier landscape. Stakeholders must monitor these dynamics to sustain access to these critical antibiotics amid evolving antimicrobial resistance challenges.