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USDMF
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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- INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- INJECTABLE;INJECTION - EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- INJECTABLE;INJECTION - EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Related Excipient Companies
Pfanstiehl
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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 HCI manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CEFEPIME HCI, including repackagers and relabelers. The FDA regulates CEFEPIME HCI manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CEFEPIME HCI 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 HCI manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A CEFEPIME HCI supplier is an individual or a company that provides CEFEPIME HCI active pharmaceutical ingredient (API) or CEFEPIME HCI finished formulations upon request. The CEFEPIME HCI suppliers may include CEFEPIME HCI API manufacturers, exporters, distributors and traders.
click here to find a list of CEFEPIME HCI suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A CEFEPIME HCI DMF (Drug Master File) is a document detailing the whole manufacturing process of CEFEPIME HCI active pharmaceutical ingredient (API) in detail. Different forms of CEFEPIME HCI DMFs exist exist since differing nations have different regulations, such as CEFEPIME HCI USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CEFEPIME HCI DMF submitted to regulatory agencies in the US is known as a USDMF. CEFEPIME HCI USDMF includes data on CEFEPIME HCI's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CEFEPIME HCI USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of CEFEPIME HCI 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 HCI Drug Master File in Japan (CEFEPIME HCI JDMF) empowers CEFEPIME HCI 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 HCI JDMF during the approval evaluation for pharmaceutical products. At the time of CEFEPIME HCI 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 HCI 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 HCI Drug Master File in Korea (CEFEPIME HCI KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of CEFEPIME HCI. The MFDS reviews the CEFEPIME HCI KDMF as part of the drug registration process and uses the information provided in the CEFEPIME HCI KDMF to evaluate the safety and efficacy of the drug.
After submitting a CEFEPIME HCI 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 HCI API can apply through the Korea Drug Master File (KDMF).
click here to find a list of CEFEPIME HCI suppliers with KDMF on PharmaCompass.
A CEFEPIME HCI CEP of the European Pharmacopoeia monograph is often referred to as a CEFEPIME HCI Certificate of Suitability (COS). The purpose of a CEFEPIME HCI CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of CEFEPIME HCI EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of CEFEPIME HCI to their clients by showing that a CEFEPIME HCI CEP has been issued for it. The manufacturer submits a CEFEPIME HCI CEP (COS) as part of the market authorization procedure, and it takes on the role of a CEFEPIME HCI CEP holder for the record. Additionally, the data presented in the CEFEPIME HCI CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the CEFEPIME HCI DMF.
A CEFEPIME HCI CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. CEFEPIME HCI 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 HCI suppliers with CEP (COS) on PharmaCompass.
A CEFEPIME HCI written confirmation (CEFEPIME HCI WC) is an official document issued by a regulatory agency to a CEFEPIME HCI manufacturer, verifying that the manufacturing facility of a CEFEPIME HCI active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting CEFEPIME HCI APIs or CEFEPIME HCI finished pharmaceutical products to another nation, regulatory agencies frequently require a CEFEPIME HCI WC (written confirmation) as part of the regulatory process.
click here to find a list of CEFEPIME HCI 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 HCI as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for CEFEPIME HCI 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 HCI 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 HCI and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CEFEPIME HCI NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of CEFEPIME HCI suppliers with NDC on PharmaCompass.
CEFEPIME HCI 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 HCI 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 HCI GMP manufacturer or CEFEPIME HCI GMP API supplier for your needs.
A CEFEPIME HCI CoA (Certificate of Analysis) is a formal document that attests to CEFEPIME HCI's compliance with CEFEPIME HCI specifications and serves as a tool for batch-level quality control.
CEFEPIME HCI CoA mostly includes findings from lab analyses of a specific batch. For each CEFEPIME HCI 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 HCI may be tested according to a variety of international standards, such as European Pharmacopoeia (CEFEPIME HCI EP), CEFEPIME HCI JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CEFEPIME HCI USP).
