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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- INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- INJECTABLE;INJECTION - EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- INJECTABLE;INJECTION - EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Faran Shimi Pharmaceutical
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ABOUT THIS PAGE
13
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 Maxipime manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Maxipime, including repackagers and relabelers. The FDA regulates Maxipime manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Maxipime 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 Maxipime manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Maxipime supplier is an individual or a company that provides Maxipime active pharmaceutical ingredient (API) or Maxipime finished formulations upon request. The Maxipime suppliers may include Maxipime API manufacturers, exporters, distributors and traders.
click here to find a list of Maxipime suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Maxipime DMF (Drug Master File) is a document detailing the whole manufacturing process of Maxipime active pharmaceutical ingredient (API) in detail. Different forms of Maxipime DMFs exist exist since differing nations have different regulations, such as Maxipime USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Maxipime DMF submitted to regulatory agencies in the US is known as a USDMF. Maxipime USDMF includes data on Maxipime's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Maxipime USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Maxipime 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 Maxipime Drug Master File in Japan (Maxipime JDMF) empowers Maxipime 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 Maxipime JDMF during the approval evaluation for pharmaceutical products. At the time of Maxipime 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 Maxipime 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 Maxipime Drug Master File in Korea (Maxipime KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Maxipime. The MFDS reviews the Maxipime KDMF as part of the drug registration process and uses the information provided in the Maxipime KDMF to evaluate the safety and efficacy of the drug.
After submitting a Maxipime 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 Maxipime API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Maxipime suppliers with KDMF on PharmaCompass.
A Maxipime CEP of the European Pharmacopoeia monograph is often referred to as a Maxipime Certificate of Suitability (COS). The purpose of a Maxipime CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Maxipime EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Maxipime to their clients by showing that a Maxipime CEP has been issued for it. The manufacturer submits a Maxipime CEP (COS) as part of the market authorization procedure, and it takes on the role of a Maxipime CEP holder for the record. Additionally, the data presented in the Maxipime CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Maxipime DMF.
A Maxipime CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Maxipime 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 Maxipime suppliers with CEP (COS) on PharmaCompass.
A Maxipime written confirmation (Maxipime WC) is an official document issued by a regulatory agency to a Maxipime manufacturer, verifying that the manufacturing facility of a Maxipime active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Maxipime APIs or Maxipime finished pharmaceutical products to another nation, regulatory agencies frequently require a Maxipime WC (written confirmation) as part of the regulatory process.
click here to find a list of Maxipime 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 Maxipime as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Maxipime 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 Maxipime 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 Maxipime and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Maxipime NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Maxipime suppliers with NDC on PharmaCompass.
Maxipime 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 Maxipime 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 Maxipime GMP manufacturer or Maxipime GMP API supplier for your needs.
A Maxipime CoA (Certificate of Analysis) is a formal document that attests to Maxipime's compliance with Maxipime specifications and serves as a tool for batch-level quality control.
Maxipime CoA mostly includes findings from lab analyses of a specific batch. For each Maxipime 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.
Maxipime may be tested according to a variety of international standards, such as European Pharmacopoeia (Maxipime EP), Maxipime JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Maxipime USP).
