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DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50679
DOSAGE - INJECTABLE;INJECTION - EQ 2GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50679
DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 50679
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PharmaCompass offers a list of Cefepime Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Cefepime Hydrochloride manufacturer or Cefepime Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cefepime Hydrochloride manufacturer or Cefepime Hydrochloride supplier.
PharmaCompass also assists you with knowing the Cefepime Hydrochloride API Price utilized in the formulation of products. Cefepime Hydrochloride API Price is not always fixed or binding as the Cefepime Hydrochloride Price is obtained through a variety of data sources. The Cefepime Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A cefepime dihydrochloride monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of cefepime dihydrochloride monohydrate, including repackagers and relabelers. The FDA regulates cefepime dihydrochloride monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. cefepime dihydrochloride monohydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of cefepime dihydrochloride monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A cefepime dihydrochloride monohydrate supplier is an individual or a company that provides cefepime dihydrochloride monohydrate active pharmaceutical ingredient (API) or cefepime dihydrochloride monohydrate finished formulations upon request. The cefepime dihydrochloride monohydrate suppliers may include cefepime dihydrochloride monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of cefepime dihydrochloride monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A cefepime dihydrochloride monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of cefepime dihydrochloride monohydrate active pharmaceutical ingredient (API) in detail. Different forms of cefepime dihydrochloride monohydrate DMFs exist exist since differing nations have different regulations, such as cefepime dihydrochloride monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A cefepime dihydrochloride monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. cefepime dihydrochloride monohydrate USDMF includes data on cefepime dihydrochloride monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The cefepime dihydrochloride monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of cefepime dihydrochloride monohydrate suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The cefepime dihydrochloride monohydrate Drug Master File in Japan (cefepime dihydrochloride monohydrate JDMF) empowers cefepime dihydrochloride monohydrate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the cefepime dihydrochloride monohydrate JDMF during the approval evaluation for pharmaceutical products. At the time of cefepime dihydrochloride monohydrate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of cefepime dihydrochloride monohydrate suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a cefepime dihydrochloride monohydrate Drug Master File in Korea (cefepime dihydrochloride monohydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of cefepime dihydrochloride monohydrate. The MFDS reviews the cefepime dihydrochloride monohydrate KDMF as part of the drug registration process and uses the information provided in the cefepime dihydrochloride monohydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a cefepime dihydrochloride monohydrate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their cefepime dihydrochloride monohydrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of cefepime dihydrochloride monohydrate suppliers with KDMF on PharmaCompass.
A cefepime dihydrochloride monohydrate CEP of the European Pharmacopoeia monograph is often referred to as a cefepime dihydrochloride monohydrate Certificate of Suitability (COS). The purpose of a cefepime dihydrochloride monohydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of cefepime dihydrochloride monohydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of cefepime dihydrochloride monohydrate to their clients by showing that a cefepime dihydrochloride monohydrate CEP has been issued for it. The manufacturer submits a cefepime dihydrochloride monohydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a cefepime dihydrochloride monohydrate CEP holder for the record. Additionally, the data presented in the cefepime dihydrochloride monohydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the cefepime dihydrochloride monohydrate DMF.
A cefepime dihydrochloride monohydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. cefepime dihydrochloride monohydrate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of cefepime dihydrochloride monohydrate suppliers with CEP (COS) on PharmaCompass.
A cefepime dihydrochloride monohydrate written confirmation (cefepime dihydrochloride monohydrate WC) is an official document issued by a regulatory agency to a cefepime dihydrochloride monohydrate manufacturer, verifying that the manufacturing facility of a cefepime dihydrochloride monohydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting cefepime dihydrochloride monohydrate APIs or cefepime dihydrochloride monohydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a cefepime dihydrochloride monohydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of cefepime dihydrochloride monohydrate suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing cefepime dihydrochloride monohydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for cefepime dihydrochloride monohydrate API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture cefepime dihydrochloride monohydrate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain cefepime dihydrochloride monohydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a cefepime dihydrochloride monohydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of cefepime dihydrochloride monohydrate suppliers with NDC on PharmaCompass.
cefepime dihydrochloride monohydrate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of cefepime dihydrochloride monohydrate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right cefepime dihydrochloride monohydrate GMP manufacturer or cefepime dihydrochloride monohydrate GMP API supplier for your needs.
A cefepime dihydrochloride monohydrate CoA (Certificate of Analysis) is a formal document that attests to cefepime dihydrochloride monohydrate's compliance with cefepime dihydrochloride monohydrate specifications and serves as a tool for batch-level quality control.
cefepime dihydrochloride monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each cefepime dihydrochloride monohydrate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
cefepime dihydrochloride monohydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (cefepime dihydrochloride monohydrate EP), cefepime dihydrochloride monohydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (cefepime dihydrochloride monohydrate USP).
