CEFEPIME HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
B Braun	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	cefepime hydrochloride	INJECTABLE;INJECTION	050821	NDA	B. Braun Medical Inc.	0264-3193-11	24 CONTAINER in 1 CASE (0264-3193-11) / 50 mL in 1 CONTAINER	2010-05-06
B Braun	CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER	cefepime hydrochloride	INJECTABLE;INJECTION	050821	NDA	B. Braun Medical Inc.	0264-3195-11	24 CONTAINER in 1 CASE (0264-3195-11) / 50 mL in 1 CONTAINER	2010-05-06
Acs Dobfar	CEFEPIME HYDROCHLORIDE	cefepime hydrochloride	INJECTABLE;INJECTION	065441	ANDA	Hospira, Inc.	0409-9566-10	10 VIAL in 1 CARTON (0409-9566-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-9566-01)	2020-08-24
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This report details the current global supplier landscape for cefepime hydrochloride, a fourth-generation cephalosporin antibiotic. Key manufacturers, their production capacities, regulatory compliance, and geographic distribution are analyzed to inform strategic R&D and investment decisions. The analysis highlights established players and emerging suppliers, with a focus on their role in meeting global demand for this critical antibiotic.

Who are the primary global manufacturers of cefepime hydrochloride active pharmaceutical ingredient (API)?

The global supply of cefepime hydrochloride API is concentrated among a few key manufacturers. These companies possess the necessary infrastructure, regulatory approvals, and scale to produce the compound to meet international pharmaceutical standards. Major suppliers include:

Sandoz International GmbH (a Novartis company): A significant player in generic pharmaceuticals, Sandoz has a well-established manufacturing base.
Teva Pharmaceutical Industries Ltd.: A leading global generics manufacturer, Teva produces a broad range of APIs, including cephalosporins.
Amneal Pharmaceuticals LLC: This US-based company has expanded its API manufacturing capabilities, including in the cephalosporin space.
Altan Pharmaceuticals: A European-based manufacturer with a focus on sterile injectables and APIs.
CordenPharma International GmbH: A contract development and manufacturing organization (CDMO) with API manufacturing sites, potentially supplying cefepime hydrochloride.
Bristol Myers Squibb: While primarily known for branded pharmaceuticals, BMS has a history of API production and may still be involved in supplying certain compounds, though its role in generics is less prominent.
Various Chinese Manufacturers: Numerous companies in China, such as Shandong Xinhua Pharmaceutical Co., Ltd. and Zhejiang NHU Co., Ltd., are significant contributors to the global API supply chain for many antibiotics, including cefepime hydrochloride. These manufacturers often offer competitive pricing.
Indian Manufacturers: Companies like Dr. Reddy's Laboratories and Sun Pharmaceutical Industries Ltd. are major API producers and are likely to be involved in the cefepime hydrochloride market.

The specific market share of each of these manufacturers can fluctuate based on production volumes, contract manufacturing agreements, and regional demand.

What is the typical production capacity and scale of these suppliers?

Production capacities for cefepime hydrochloride API are not always publicly disclosed in precise figures. However, major manufacturers operate multi-tonnage scale facilities to meet global demand.

Large-scale API manufacturers (e.g., Sandoz, Teva, major Chinese and Indian producers) typically have annual capacities ranging from 100 to 500 metric tons for key antibiotic APIs, which would include cefepime hydrochloride. These facilities are often equipped with multiple reactor lines, advanced purification systems, and sterile processing capabilities.
Specialized or CDMOs may operate with more flexible capacities, potentially ranging from tens to hundreds of metric tons annually, depending on client demand and specific campaign manufacturing.
The scale of production is directly influenced by the global demand for finished dosage forms of cefepime hydrochloride, which is a widely used antibiotic for moderate to severe infections. Factors such as disease prevalence, healthcare access in different regions, and the availability of alternative treatments impact overall volume requirements.

Which regulatory bodies have approved the manufacturing sites for cefepime hydrochloride API?

Manufacturers of cefepime hydrochloride API must comply with stringent regulatory requirements from major health authorities to supply global markets. Key approvals and inspections are sought from:

U.S. Food and Drug Administration (FDA): Sites manufacturing API for the U.S. market must undergo FDA inspections and receive approval. This includes inspections under Current Good Manufacturing Practices (cGMP).
European Medicines Agency (EMA) and National Competent Authorities: Manufacturers supplying to the European Union require compliance with EU GMP guidelines, often assessed through inspections by national regulatory bodies within the EU. Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEPs) are also crucial for market access.
Japan's Pharmaceuticals and Medical Devices Agency (PMDA): Japanese market access requires compliance with Japanese GMP standards and potential site inspections.
World Health Organization (WHO): For countries relying on WHO prequalification programs, manufacturing sites must meet WHO GMP standards.
Other National Regulatory Agencies: Manufacturers may also need approvals from agencies in countries like Canada (Health Canada), Australia (Therapeutic Goods Administration - TGA), and various other national health authorities depending on their target markets.

A review of FDA establishment registration and drug master file (DMF) filings can provide insights into which facilities are approved for API production for the U.S. market. Similarly, the European Directorate for the Quality of Medicines & HealthCare (EDQM) website lists CEP holders, indicating compliance with European Pharmacopoeia standards.

What is the typical purity and quality specification for pharmaceutical-grade cefepime hydrochloride?

Pharmaceutical-grade cefepime hydrochloride API must meet rigorous purity and quality specifications as defined by pharmacopoeias and regulatory agencies. These specifications ensure the safety and efficacy of the final drug product.

Parameter	Specification	Method of Analysis (Typical)
Assay (Potency)	Not less than 90.0% and not more than 102.0% of C23H24N6O5S2, calculated on the anhydrous, solvent-free basis.	HPLC (High-Performance Liquid Chromatography)
pH (of a solution)	4.0 – 6.0 (e.g., for a 1% w/v solution)	Potentiometry
Water Content	Not more than 3.0%	Karl Fischer Titration
Residue on Ignition	Not more than 0.1%	Gravimetric analysis
Heavy Metals	Not more than 10 ppm (parts per million)	Spectrophotometry/ICP-MS
Related Substances	Individual unknown impurities: not more than 0.10%	HPLC
	Total impurities: not more than 1.0%	HPLC
Residual Solvents	Conforms to ICH Q3C guidelines (e.g., limits for methanol, ethanol, acetone, etc.)	Gas Chromatography (GC)
Sterility	Meets the requirements of the Sterility Test (USP/EP)	Microbiological testing
Bacterial Endotoxins	Meets the requirements for injectable products (e.g., < 0.25 EU/mg for parenteral use)	LAL (Limulus Amebocyte Lysate) assay

These specifications are generally harmonized across major pharmacopoeias like the United States Pharmacopoeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP). Manufacturers must demonstrate consistent adherence to these standards through robust quality control and assurance systems.

What are the primary geographical regions for cefepime hydrochloride API manufacturing?

The manufacturing of cefepime hydrochloride API is geographically distributed, with significant contributions from Asia and, to a lesser extent, Europe and North America.

China: Dominates global API production for many antibiotics due to lower manufacturing costs, extensive chemical synthesis infrastructure, and a large number of active pharmaceutical ingredient manufacturers. Major hubs include provinces like Shandong, Jiangsu, and Zhejiang.
India: A leading global supplier of generic APIs, India has a well-established pharmaceutical industry with numerous companies capable of producing complex molecules like cefepime hydrochloride. Production is concentrated in regions like Gujarat, Maharashtra, and Andhra Pradesh.
Europe: While less dominant in high-volume, low-cost API production, European manufacturers, particularly in Germany, Switzerland, and Italy, often focus on high-value, complex APIs or operate as contract manufacturers for Western pharmaceutical companies, ensuring strict adherence to regulatory standards.
North America (USA): Some API manufacturing exists in the U.S., often for specialized products or to ensure supply chain security, but it is less prevalent for high-volume generic APIs compared to Asia.

The dominance of China and India in API manufacturing reflects their competitive cost structures and significant investment in chemical synthesis capabilities. However, concerns regarding supply chain resilience and quality control can lead to diversification efforts by pharmaceutical companies, sometimes favoring European or North American suppliers for critical APIs.

What is the patent landscape surrounding cefepime hydrochloride?

Cefepime hydrochloride itself is an established drug, and its original composition of matter patents have long expired. However, the patent landscape can still be relevant for:

Process Patents: These patents cover specific methods of synthesizing cefepime hydrochloride, novel purification techniques, or polymorphic forms of the API. Companies may hold patents on improved or more cost-effective manufacturing processes.
Formulation Patents: Patents may exist for specific drug product formulations, such as ready-to-use lyophilized powders, improved stability formulations, or combination therapies involving cefepime.
New Use Patents: While less common for older antibiotics, patents could theoretically be granted for novel therapeutic applications of cefepime hydrochloride discovered after its initial market approval.

A search of patent databases such as those maintained by the United States Patent and Trademark Office (USPTO), the European Patent Office (EPO), and the World Intellectual Property Organization (WIPO) is necessary to identify any active patents related to manufacturing processes or novel formulations. Companies actively developing new manufacturing methods or stable formulations may seek patent protection. For example, patents might cover:

Specific crystallization conditions to achieve desired particle size or polymorphic form.
Methods for reducing specific impurities during synthesis.
Formulations that enhance solubility or shelf-life.

The absence of composition of matter patents means that generic manufacturers can legally produce and sell cefepime hydrochloride once regulatory approval is obtained, provided they do not infringe on any existing process or formulation patents.

What are the key regulatory considerations for API suppliers and finished drug manufacturers?

Suppliers of cefepime hydrochloride API and manufacturers of the finished drug product must navigate a complex web of regulatory requirements to ensure product quality, safety, and market access.

API Suppliers:
- cGMP Compliance: Manufacturers must adhere to current Good Manufacturing Practices (cGMP) as defined by regulatory bodies (FDA, EMA, etc.). This encompasses facility design, equipment validation, process control, personnel training, and quality management systems.
- Drug Master Files (DMFs) / Certificates of Suitability (CEPs): API suppliers typically file DMFs with regulatory agencies like the FDA, providing detailed information about the manufacturing process, controls, and quality of the API. For the EU market, CEPs issued by the EDQM are essential.
- Impurity Profiling and Control: Strict control and characterization of impurities, including residual solvents, heavy metals, and related substances, are mandatory. Limits are set by pharmacopoeias and ICH guidelines.
- Stability Testing: API must undergo rigorous stability testing to establish shelf-life and appropriate storage conditions.
- Supply Chain Transparency: Ensuring the security and traceability of raw materials used in API synthesis is increasingly important.
Finished Drug Manufacturers:
- ANDA / MAA Submissions: To market generic cefepime hydrochloride injections, companies must submit an Abbreviated New Drug Application (ANDA) to the FDA or a Marketing Authorisation Application (MAA) to the EMA. These submissions require detailed information on the finished product, including the API source, formulation, manufacturing process, and bioequivalence studies.
- API Sourcing and Qualification: Finished drug manufacturers must rigorously qualify their API suppliers, ensuring they meet cGMP standards and provide high-quality API. Audits of API manufacturing sites are common.
- Sterility Assurance: As cefepime hydrochloride is typically an injectable, manufacturers must demonstrate robust sterility assurance through validated aseptic processing or terminal sterilization methods.
- Product Specification and Stability: The finished drug product must meet defined specifications for potency, purity, dissolution (if applicable, though less so for injectables), and stability.
- Pharmacovigilance: Post-market surveillance and reporting of adverse events are critical.

Navigating these regulations is a significant barrier to entry and requires substantial investment in quality systems, personnel, and documentation.

What are the potential risks and challenges in the cefepime hydrochloride supply chain?

The supply chain for cefepime hydrochloride, like many pharmaceutical APIs, faces several risks and challenges:

Geopolitical and Supply Chain Disruptions: Over-reliance on specific geographical regions (e.g., China, India) for API production can create vulnerabilities due to trade disputes, natural disasters, pandemics, or political instability in those regions.
Quality Control and Compliance Issues: Ensuring consistent quality and adherence to cGMP across multiple manufacturing sites, especially in rapidly developing API production hubs, can be challenging. Regulatory actions against non-compliant facilities can lead to immediate supply shortages.
Price Volatility: Raw material costs, energy prices, and increasing regulatory compliance burdens can lead to fluctuations in API pricing, impacting the cost-effectiveness of finished drug products.
Intellectual Property Disputes: While the core molecule may be off-patent, disputes over process patents or novel formulations can lead to legal challenges and market disruptions.
Environmental Regulations: Increasingly stringent environmental regulations in API manufacturing hubs can lead to production slowdowns or increased costs as companies invest in pollution control measures.
Antimicrobial Resistance (AMR) and Stewardship: While not a direct supply chain risk, global efforts to combat AMR and promote antimicrobial stewardship can indirectly influence demand for older antibiotics like cefepime hydrochloride, potentially impacting long-term production planning.
Consolidation among Suppliers: Mergers and acquisitions within the API manufacturing sector can lead to reduced competition and potential price increases.

Pharmaceutical companies often mitigate these risks through multi-sourcing strategies, rigorous supplier qualification, maintaining safety stocks, and investing in diversified manufacturing footprints.

Key Takeaways

The global supply of cefepime hydrochloride API is dominated by manufacturers in China and India, with established players like Sandoz and Teva also maintaining significant roles. Production capacities are substantial, often in the multi-tonnage range, catering to global demand. Compliance with stringent regulatory standards from bodies like the FDA and EMA is paramount, necessitating robust cGMP practices and detailed DMF/CEP filings. Purity and quality specifications are defined by pharmacopoeias, with strict limits on impurities, water content, and residual solvents, and critical requirements for sterility and bacterial endotoxins for injectable formulations. While the composition of matter patents for cefepime hydrochloride have expired, process and formulation patents remain relevant. Key risks in the supply chain include geopolitical instability, quality control challenges, price volatility, and the impact of environmental regulations, necessitating diversification and rigorous supplier management.

Frequently Asked Questions

What is the typical lead time for procuring cefepime hydrochloride API from a new supplier?

The typical lead time for procuring cefepime hydrochloride API from a new supplier can range from 3 to 9 months. This period accounts for supplier qualification processes, including site audits, quality agreement finalization, sample analysis, and initial order placement. Established suppliers with existing contracts may have shorter lead times for repeat orders, often ranging from 4 to 12 weeks, depending on production schedules and inventory levels.

How does the availability of alternative antibiotics affect the demand for cefepime hydrochloride?

The demand for cefepime hydrochloride is influenced by the availability and efficacy of alternative antibiotics, particularly for specific types of bacterial infections. For instance, the emergence and spread of multidrug-resistant bacteria, including carbapenem-resistant Enterobacteriaceae (CRE), can shift treatment guidelines. While cefepime remains a critical agent for many Gram-negative infections, the development and adoption of newer antibiotics with broader or more targeted spectra of activity, or those effective against resistant strains, can lead to a decline in its use for certain indications. Conversely, the need for cost-effective broad-spectrum agents in resource-limited settings can sustain demand.

What are the primary challenges in ensuring the sterility of cefepime hydrochloride for injectable use?

Ensuring the sterility of cefepime hydrochloride for injectable use presents several challenges. These include the inherent susceptibility of the API to microbial contamination during manufacturing, the need for highly controlled aseptic processing environments, and the effectiveness of terminal sterilization methods if employed. Maintaining the integrity of packaging materials and preventing cross-contamination throughout the filling and finishing processes are critical. Furthermore, rigorous environmental monitoring, validated cleaning procedures, and personnel gowning protocols are essential to mitigate risks and achieve the required sterility assurance levels as mandated by pharmacopoeias and regulatory bodies.

Can the manufacturing process for cefepime hydrochloride be significantly altered without requiring a new patent application?

The manufacturing process for cefepime hydrochloride can be altered without requiring a new patent application if the changes are incremental, do not constitute a novel invention, or if the original process patents have expired. However, if an alteration results in a significantly improved yield, reduced impurity profile, novel polymorphic form, or a more cost-effective and inventive synthesis route, it may be eligible for patent protection. Companies often patent such process improvements to secure a competitive advantage, even if the underlying composition of matter is no longer patent-protected.

What is the impact of global regulatory harmonization efforts on cefepime hydrochloride API suppliers?

Global regulatory harmonization efforts, such as those driven by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), significantly impact cefepime hydrochloride API suppliers. Harmonized guidelines on quality, such as ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients), Q3A (Impurities in New Drug Substances), and Q3C (Impurities: Guideline for Residual Solvents), promote consistent standards across major markets. This reduces the burden on suppliers to develop unique quality systems for each region, simplifying compliance and facilitating international trade. Suppliers are expected to meet the highest common denominator of these harmonized standards to access global markets effectively.

Cited Sources

[1] United States Pharmacopeia. (n.d.). Cefepime Hydrochloride. The United States Pharmacopeia. [2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Certificate of Suitability (CEP). EDQM. [3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Guidelines. ICH.

Suppliers and packagers for generic pharmaceutical drug: CEFEPIME HYDROCHLORIDE