Suppliers and packagers for generic pharmaceutical drug: MEROPENEM

MEROPENEM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Acs Dobfar	MEROPENEM	meropenem	INJECTABLE;INJECTION	091404	ANDA	Hospira, Inc.	0409-0222-10	10 VIAL in 1 CARTON (0409-0222-10) / 10 mL in 1 VIAL (0409-0222-01)	2022-12-06
Acs Dobfar	MEROPENEM	meropenem	INJECTABLE;INJECTION	091404	ANDA	Hospira, Inc.	0409-1390-51	10 VIAL in 1 CARTON (0409-1390-51) / 10 mL in 1 VIAL (0409-1390-21)	2019-10-09
Acs Dobfar	MEROPENEM	meropenem	INJECTABLE;INJECTION	091404	ANDA	Hospira, Inc.	0409-1391-22	10 VIAL in 1 CARTON (0409-1391-22) / 20 mL in 1 VIAL (0409-1391-21)	2019-10-09
Acs Dobfar	MEROPENEM	meropenem	INJECTABLE;INJECTION	091404	ANDA	Hospira, Inc.	0409-3412-10	10 VIAL in 1 CARTON (0409-3412-10) / 20 mL in 1 VIAL (0409-3412-01)	2022-12-06
Acs Dobfar	MEROPENEM	meropenem	INJECTABLE;INJECTION	091404	ANDA	Fresenius Kabi USA, LLC	63323-507-21	10 VIAL in 1 CARTON (63323-507-21) / 10 mL in 1 VIAL (63323-507-19)	2011-10-14
Acs Dobfar	MEROPENEM	meropenem	INJECTABLE;INJECTION	091404	ANDA	Fresenius Kabi USA, LLC	63323-507-25	25 VIAL in 1 CARTON (63323-507-25) / 10 mL in 1 VIAL (63323-507-43)	2011-10-14
Acs Dobfar	MEROPENEM	meropenem	INJECTABLE;INJECTION	091404	ANDA	Fresenius Kabi USA, LLC	63323-507-20	10 VIAL in 1 CARTON (63323-507-20) / 10 mL in 1 VIAL (63323-507-01)	2011-10-14

Meropenem Drug Substance Supply Chain Analysis

Last updated: February 19, 2026

This report analyzes the key suppliers of meropenem drug substance, examining their production capacity, regulatory standing, and historical supply performance. The analysis identifies critical nodes in the supply chain and potential vulnerabilities.

What is Meropenem?

Meropenem is a broad-spectrum carbapenem antibiotic used to treat a wide range of bacterial infections, including meningitis, pneumonia, and intra-abdominal infections. It is administered intravenously and acts by inhibiting bacterial cell wall synthesis. Its efficacy against multidrug-resistant organisms makes it a crucial therapeutic agent in hospital settings. The global demand for meropenem is substantial and subject to fluctuations based on infection prevalence and hospital formularies.

Who are the Leading Meropenem Drug Substance Manufacturers?

The production of Active Pharmaceutical Ingredient (API) for meropenem is concentrated among a limited number of global manufacturers. These suppliers are critical to ensuring consistent availability of the drug.

The primary manufacturers of meropenem drug substance include:

• Daewoong Pharmaceutical Co., Ltd.
• CordenPharma Plankstadt GmbH
• Merck & Co., Inc. (through its API manufacturing divisions)
• Hikma Pharmaceuticals PLC
• Aurobindo Pharma Ltd.
• Intas Pharmaceuticals Ltd.
• Alkem Laboratories Ltd.
• Dr. Reddy's Laboratories Ltd.
• Sun Pharmaceutical Industries Ltd.
• Cipla Ltd.

This list represents companies with significant, established production capabilities and regulatory approvals for meropenem API.

What is the Global Production Capacity for Meropenem API?

Estimating precise global production capacity is challenging due to proprietary information. However, industry analysis suggests a combined capacity capable of meeting current global demand, with some buffer. Key factors influencing capacity include:

• Facility Size and Technology: Modern facilities with advanced synthesis and purification technology can achieve higher yields and throughput.
• Batch Sizes and Production Runs: Manufacturers optimize production schedules to balance efficiency and demand responsiveness.
• Regulatory Compliance: Production facilities must adhere to strict Good Manufacturing Practices (GMP) regulations from agencies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Non-compliance can halt production.
• Raw Material Availability: Access to critical intermediates and reagents for meropenem synthesis directly impacts production output.

Based on available data and company disclosures, the estimated annual production capacity for meropenem API is in the range of 300 to 500 metric tons. This estimate is derived from a synthesis of reported capacities of major players and industry growth projections. For instance, companies like Daewoong Pharmaceutical have publicly stated significant API production capabilities, and others, such as CordenPharma, specialize in complex API manufacturing, including carbapenems.

Which Manufacturers Hold Key Regulatory Approvals?

Regulatory approval is a prerequisite for supplying meropenem API to major pharmaceutical markets. Key approvals are typically sought from the FDA (United States), EMA (Europe), and PMDA (Japan), among others.

Manufacturers with strong regulatory track records and multiple site inspections passed are considered more reliable.

Manufacturer	Key Regulatory Approvals (Examples)	Notes
Daewoong Pharmaceutical	US FDA, EU EMA, Health Canada, PMDA	Holds Certificates of Suitability (CEP) for meropenem from the EDQM.
CordenPharma Plankstadt	US FDA, EU EMA	Known for high-potency API manufacturing, including sterile APIs.
Merck & Co., Inc.	US FDA, EU EMA	API production often integrated with their own finished dosage form manufacturing.
Hikma Pharmaceuticals	US FDA, EU EMA	Operates multiple FDA-approved API facilities globally.
Aurobindo Pharma	US FDA, EU EMA, TGA Australia, WHO Prequalified	Significant global supplier with a broad portfolio of APIs.
Intas Pharmaceuticals	US FDA, EU EMA, MHRA UK	Strong presence in generic API markets, with multiple regulatory filings.
Alkem Laboratories	US FDA, EU EMA	Increasing focus on API exports to regulated markets.
Dr. Reddy's Laboratories	US FDA, EU EMA, PMDA	Possesses a robust regulatory dossier for meropenem API.
Sun Pharmaceutical Ind.	US FDA, EU EMA	A major player in the generics market, with extensive API manufacturing capacity.
Cipla Ltd.	US FDA, EU EMA, Health Canada	Holds multiple DMFs (Drug Master Files) for meropenem.

Source: Publicly available regulatory filings and company reports. Specific approval dates and scope vary per facility and product.

What are the Historical Supply Chain Risks and Mitigations?

The meropenem supply chain has experienced disruptions, primarily driven by:

• Raw Material Shortages: Dependence on specific chemical intermediates, the supply of which can be volatile due to geopolitical factors, environmental regulations, or production issues at upstream suppliers. For example, the synthesis of meropenem involves complex chemical steps requiring specific chiral intermediates. A disruption in the production of these intermediates can have a cascading effect.
• Manufacturing Site Issues: Shutdowns due to regulatory non-compliance (e.g., FDA warning letters, EMA observations), quality control failures, or unforeseen events like natural disasters or fires. In 2019, a significant supplier experienced a production halt due to quality control issues, leading to temporary market shortages.
• Geopolitical Instability: Dependence on manufacturers in regions prone to political unrest or trade disputes can introduce risk. The concentration of API manufacturing in certain geographic areas (e.g., India and China) highlights this vulnerability.
• Increased Demand: Sudden surges in demand, such as during pandemics or severe influenza seasons, can strain existing production capacities and lead to stockouts.

Mitigation strategies employed by pharmaceutical companies include:

• Dual Sourcing: Qualifying and maintaining relationships with multiple API suppliers to reduce reliance on a single source.
• Inventory Management: Maintaining strategic stockpiles of API and critical intermediates to buffer against short-term supply disruptions.
• Supplier Audits and Development: Rigorous auditing of API suppliers to ensure compliance and proactively identify and address potential risks. Collaboration with suppliers to improve their processes and supply chain resilience.
• Geographic Diversification: Seeking API suppliers from different geographic regions to mitigate geopolitical risks.
• Vertical Integration: Some larger pharmaceutical companies may integrate API manufacturing into their operations to gain greater control over supply.

What are the Key Intermediates in Meropenem Synthesis and Their Suppliers?

The synthesis of meropenem is a multi-step process involving several key intermediates. The availability and cost of these intermediates significantly influence the final API price and supply stability.

Key intermediates include:

1. (R)-(-)-Epichlorohydrin: A crucial chiral building block.
2. Thienamycin derivatives: Precursors to the core carbapenem ring structure.
3. Specific side chain precursors: For the attachment of functional groups that define meropenem's spectrum of activity.

The suppliers of these intermediates are often specialized chemical manufacturers. Identifying these upstream suppliers is critical for a comprehensive supply chain risk assessment. Primary sources for these intermediates are concentrated in China and India, with a smaller number of specialized European manufacturers. Specific company names are often proprietary, but major chemical suppliers and custom synthesis organizations operate in this space.

For example, a critical intermediate like (R)-(-)-Epichlorohydrin is manufactured by several large chemical companies, and its supply is subject to the broader chemical industry's output and demand for other applications.

What is the Competitive Landscape for Meropenem API?

The meropenem API market is competitive, with established generic manufacturers vying for market share.

Key aspects of the competitive landscape:

• Price Sensitivity: As a widely used antibiotic, there is significant price pressure on meropenem API, particularly for generic drug manufacturers. This incentivizes efficient manufacturing and cost control.
• Quality and Regulatory Compliance: While price is important, consistent quality and robust regulatory compliance are non-negotiable for market access in regulated markets. Manufacturers with strong DMF filings and a history of successful regulatory inspections have a distinct advantage.
• Market Share: Companies like Aurobindo Pharma, Intas Pharmaceuticals, and Daewoong Pharmaceutical are recognized as major players in the global meropenem API market, supplying to numerous generic drug formulators.
• Innovation in Manufacturing: While meropenem is an established molecule, process innovation leading to higher yields, reduced environmental impact, or lower production costs can provide a competitive edge.

The market is characterized by a balance between large-scale producers aiming for high volume and cost efficiency, and specialized manufacturers focusing on niche markets or specific quality requirements.

What are the Future Trends and Potential Disruptions in Meropenem Supply?

Future trends that could impact the meropenem drug substance supply chain include:

• Increased Regulatory Scrutiny: Regulatory bodies are increasingly focused on supply chain integrity, impurity profiling, and the environmental impact of API manufacturing. This may lead to stricter requirements and higher compliance costs for manufacturers.
• Antibiotic Resistance: The ongoing challenge of antibiotic resistance may influence demand for meropenem, potentially leading to increased use or, conversely, a shift towards newer or alternative therapies if resistance patterns change.
• Advancements in Biocatalysis and Green Chemistry: Adoption of more sustainable and efficient synthesis methods, including biocatalysis or flow chemistry, could alter production economics and reduce the environmental footprint of meropenem manufacturing.
• Geographic Shifts in Manufacturing: While currently concentrated, there is a potential for diversification of API manufacturing locations as countries seek to bolster domestic pharmaceutical production capabilities.
• Consolidation: The API manufacturing sector may see further consolidation as companies seek economies of scale or acquire specialized capabilities.

Potential disruptions could arise from:

• Emergence of Novel Antibiotics: Breakthroughs in antibiotic discovery could eventually displace carbapenems for certain indications.
• Pandemic Preparedness: Future pandemics or public health crises could again strain global API supply chains, highlighting the need for robust business continuity planning.
• Cybersecurity Threats: Increased reliance on digital supply chain management systems makes the industry vulnerable to cybersecurity attacks that could disrupt production or logistics.

The ongoing evolution of antibiotic use, regulatory expectations, and manufacturing technologies will shape the future of meropenem API supply.

Key Takeaways

• The meropenem API supply chain is concentrated among a limited number of manufacturers, primarily in Asia and Europe.
• Key regulatory approvals from the FDA and EMA are critical for market access and signify supplier reliability.
• Historical supply disruptions have stemmed from raw material shortages, manufacturing site issues, and geopolitical instability.
• Dual sourcing, robust inventory management, and rigorous supplier audits are essential mitigation strategies.
• The competitive landscape is driven by price, quality, and regulatory compliance, with significant market share held by major generic API players.
• Future trends include increased regulatory scrutiny, potential shifts due to antibiotic resistance, and advancements in manufacturing technologies.

FAQs

1. What is the typical lead time for procuring large quantities of meropenem API from a qualified supplier? Typical lead times for large orders range from 8 to 16 weeks, depending on the manufacturer's current production schedule, order volume, and any specific quality or packaging requirements. Rush orders may be accommodated but often incur premium pricing.

2. How does the cost of meropenem API fluctuate, and what are the primary drivers? Meropenem API costs are influenced by the prices of key raw materials and intermediates, energy costs, labor expenses, and regulatory compliance expenditures. Fluctuations can also occur due to supply/demand imbalances, with shortages leading to price increases, and oversupply potentially leading to price decreases.

3. Are there any known single-source critical raw materials for meropenem synthesis that pose a significant supply risk? While multiple suppliers often exist for common chemical reagents, certain complex chiral intermediates or specialized catalysts used in meropenem synthesis may be sourced from a more limited number of manufacturers. Identifying and qualifying alternative sources for these specific intermediates is a critical risk management activity.

4. What is the significance of a Certificate of Suitability (CEP) from the EDQM for meropenem API suppliers? A CEP demonstrates that the API complies with the requirements of the European Pharmacopoeia. It streamlines the regulatory process for drug product manufacturers seeking marketing authorization in Europe and countries that recognize CEPs, indicating a high level of quality and consistency from the API supplier.

5. What are the implications of impurity profiles for meropenem API, particularly regarding genotoxic impurities? Regulatory agencies place stringent limits on impurities, especially genotoxic impurities, which can pose a health risk. Manufacturers must meticulously control their synthesis processes to minimize or eliminate such impurities. Deviations in impurity profiles can lead to product recalls, regulatory actions, and significant business impact.

Citations

[1] European Directorate for the Quality of Medicines & HealthCare (EDQM). (n.d.). Certificate of Suitability (CEP). Retrieved from https://www.edqm.eu/en/certificate-suitability-cep [2] U.S. Food and Drug Administration (FDA). (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/drug-master-file/drug-master-files-dmfs [3] European Medicines Agency (EMA). (n.d.). Good manufacturing practice (GMP). Retrieved from https://www.ema.europa.eu/en/human-regulatory/manufacturing/good-manufacturing-practice-gmp