ERTAPENEM SODIUM: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Acs Dobfar Spa	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	208790	ANDA	Hikma Pharmaceuticals USA, Inc.	0143-9398-10	10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9398-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9398-01)	2021-08-02
Acs Dobfar Spa	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	208790	ANDA	Hospira, Inc.	0409-3510-22	10 VIAL, SINGLE-DOSE in 1 CARTON (0409-3510-22) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0409-3510-21)	2020-10-19
Acs Dobfar Spa	ERTAPENEM SODIUM	ertapenem sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	208790	ANDA	WG Critical Care, LLC	44567-820-10	10 VIAL, SINGLE-DOSE in 1 CARTON (44567-820-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (44567-820-01)	2020-01-07
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

Ertapenem sodium is a broad-spectrum carbapenem antibiotic used extensively in hospital and clinical settings to treat various severe bacterial infections. Its efficacy against multidrug-resistant strains makes it a vital component in the anti-infective arsenal. With the global rise in antibiotic resistance, securing reliable suppliers for ertapenem sodium becomes paramount for pharmaceutical companies, healthcare providers, and government health agencies. This article examines key suppliers, their manufacturing capabilities, regulatory statuses, and market positioning to provide a comprehensive overview for stakeholders.

Manufacturers of Ertapenem Sodium

1. Merck & Co. / MSD (United States)

Merck & Co., under the brand name Invanz, holds the original patent and regulatory approvals for ertapenem sodium. As the pioneer, Merck's manufacturing facilities in the United States and international subsidiaries produce high-quality ertapenem sodium. The company maintains strict compliance with Good Manufacturing Practices (GMP) and holds extensive approvals from the FDA and EMA, positioning it as a primary supplier for global markets.

Strengths:

Established global manufacturing infrastructure
Strict adherence to international regulatory standards
Proven supply chain resilience

Limitations:

Higher pricing due to patent protections and proprietary manufacturing processes

2. Sandoz / Novartis (Switzerland)

As a leader in generic pharmaceuticals, Sandoz manufactures and supplies biosimilar versions of ertapenem sodium in multiple regions, including Europe and select Asian markets. Their production facilities in Europe are GMP-certified, enabling widespread distribution.

Strengths:

Competitive pricing
Wide geographic distribution network
Experienced in biosimilars and generics manufacturing

Limitations:

Regulatory approval timelines may vary across countries
Possible variations in bioequivalence studies depending on local regulatory requirements

3. Qingdao Bright Moon Seaweed Group (China)

While primarily known for plant-based alginate products, Qingdao Bright Moon has recently diversified into complex pharmaceuticals, including the manufacture of carbapenem antibiotics like ertapenem sodium in China.

Strengths:

Cost-effective manufacturing with local Chinese market focus
Growing expertise in complex APIs and sterilized formulations

Limitations:

Limited international regulatory approvals for global export
Lower brand recognition compared to Western pharmaceutical giants

4. Wuhan Pharscin Pharmaceutical Co. Ltd. (China)

This Wuhan-based manufacturer has established an API manufacturing plant specializing in carbapenems. They've gained approval for domestic distribution and are expanding into international markets, especially Southeast Asia and Africa.

Strengths:

Competitive pricing structures
Rapid expansion into emerging markets

Limitations:

Regulatory hurdles for Western markets
Need for further quality certifications to match international standards

5. Teva Pharmaceutical Industries (Israel)

Though not currently a major producer of ertapenem sodium, Teva's extensive API manufacturing capacity and distribution network indicate potential future entry into this market. Their focus on generics and biosimilars suggests capacity expansion.

Strengths:

Global distribution channels
Established reputation in generic pharmaceuticals

Limitations:

No current manufacturing data specific to ertapenem sodium

Market Dynamics and Supply Considerations

Regulatory Landscape

Ertapenem sodium's complex chemical synthesis demands strict quality controls, especially given its critical hospital use. Regulatory approvals from agencies like the FDA, EMA, and China's NMPA influence supplier credibility and market access. Manufacturers with approved manufacturing facilities can assure uninterrupted supply.

Manufacturing Capabilities

Supply chain stability hinges on manufacturing capacity, raw material sourcing, and compliance with GMP. Top-tier suppliers like Merck & Co. maintain multiple manufacturing sites with validated processes, ensuring high-volume production. Chinese manufacturers' capacities are expanding, but often require further validation to meet international standards.

Pricing and Accessibility

While brand-name producers generally command higher prices, the emergence of biosimilars and generics from China and India offers cost-effective alternatives. Stakeholders must evaluate quality assurances alongside cost considerations, especially for public health procurement.

Intellectual Property Rights

Patent expiration, which varies by jurisdiction, allows generic manufacturing to proliferate. In regions where patents have lapsed, multiple suppliers offer ertapenem sodium, boosting competition and access. Conversely, patent-holding companies may retain exclusive rights elsewhere.

Quality and Regulatory Compliance

Suppliers' ability to meet stringent GMP standards is crucial. Regulatory agencies conduct rigorous inspections, and suppliers adept at navigating these requirements can better assure drug safety and efficacy. International approvals and certifications such as ISO are also indicators of compliance.

Strategic Considerations for Stakeholders

Healthcare Providers and Pharmacists: Prioritize suppliers with consistent quality records and regulatory approvals, balancing cost and supply reliability.
Pharmaceutical Companies: Consider establishing manufacturing partnerships with high-volume suppliers to ensure uninterrupted supply chains or develop in-house capabilities.
Government Agencies: Promote competition among generic manufacturers to lower costs and enhance supply security, especially in public health programs.

Key Challenges in the Supply Chain

Raw material shortages: The complex synthesis of ertapenem sodium depends on specific precursors, which can become bottlenecks.
Regulatory delays: Approvals and inspections vary, impacting new suppliers’ market entry.
Quality assurance: Variability in API quality can affect clinical outcomes, requiring robust quality control systems.
Market fluctuations: Global demand spikes, such as during epidemics, strain supply chains, necessitating proactive capacity planning.

Future Outlook

The ertapenem sodium supply landscape is evolving with increased manufacturing capacities in China and India, driven by patent expirations and technological advancements. Regulatory harmonization and quality standard upgrades are essential for expanding access. Emerging biosimilars may also influence the market, fostering competition and potentially reducing prices.

Key Takeaways

Merck & Co. remains the leading supplier with proven quality and regulatory standing but commands higher prices.
Chinese manufacturers such as Qingdao Bright Moon and Wuhan Pharscin are increasing their contribution, offering cost-effective options with expanding regulatory approvals.
Suppliers' manufacturing scalability, regulatory compliance, and quality controls are critical factors influencing supply stability.
Stakeholders should develop diversified supplier networks to mitigate risks associated with raw material shortages, regulatory delays, and market fluctuations.
Continuous monitoring of global regulatory developments and capacity building will be essential to meet the rising demand for ertapenem sodium efficiently.

FAQs

1. Are biosimilar versions of ertapenem sodium available globally?
Yes, mainly from Chinese and Indian manufacturers, offering cost-effective alternatives. However, their regulatory approvals vary by country, impacting global availability.

2. What are the primary challenges in sourcing ertapenem sodium?
Challenges include ensuring consistent quality, navigating complex regulatory approvals, raw material supply constraints, and managing costs.

3. How does patent status affect the availability of generic ertapenem sodium?
Patent expiration in key markets allows generic manufacturers to produce and sell ertapenem sodium, increasing competition and accessibility.

4. Which regulatory agencies approve ertapenem sodium manufacturing?
The FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and NMPA (China’s National Medical Products Administration) are the key regulatory bodies.

5. What should healthcare providers consider when choosing a supplier for ertapenem sodium?
They should assess regulatory approval status, manufacturing quality standards, supply chain reliability, and cost implications.

References

[1] FDA Drug Approvals and Labeling. U.S. Food and Drug Administration. 2022.
[2] EMA Medicines Database. European Medicines Agency. 2022.
[3] WHO Good Manufacturing Practices Guidelines. World Health Organization. 2021.
[4] Global API Manufacturing Industry Insights. Pharma Business Reports. 2022.
[5] Patent Status of Ertapenem in Major Markets. Intellectual Property Office Records. 2023.

Suppliers and packagers for generic pharmaceutical drug: ERTAPENEM SODIUM