Synopsis
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KDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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API SUPPLIERS
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
CEP/COS 
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-17
Pay. Date : 2014-05-12
DMF Number : 27805
Submission : 2013-12-28
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26447
Submission : 2012-09-26
Status :
Type : II
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Certificate Number : R0-CEP 2017-243 - Rev 01
Status : Valid
Issue Date : 2022-03-22
Type : Chemical
Substance Number : 3011
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API Imports and Exports
Drugs in Development
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DOSAGE - TABLET;ORAL - 5MG **Federal Register...DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 10104
DOSAGE - INJECTABLE;INJECTION - 10MG/ML ***Fe...DOSAGE - INJECTABLE;INJECTION - 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 12223
DOSAGE - INJECTABLE;INJECTION - 1MG/0.5ML **F...DOSAGE - INJECTABLE;INJECTION - 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 12223
DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL...DOSAGE - FOR SOLUTION;INTRAVENOUS - 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG BASE/VIAL;0.7MG/VIAL;7MG/VIAL
USFDA APPLICATION NUMBER - 18920
DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/...DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML
USFDA APPLICATION NUMBER - 21163
DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/...DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML
USFDA APPLICATION NUMBER - 21163
DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;...DOSAGE - INJECTABLE;INTRAVENOUS - 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL
USFDA APPLICATION NUMBER - 21625
DOSAGE - INJECTABLE;INJECTION - 1MG/0.5ML
USFDA APPLICATION NUMBER - 83722
DOSAGE - INJECTABLE;INJECTION - 1MG/0.5ML
USFDA APPLICATION NUMBER - 87954
DOSAGE - INJECTABLE;INJECTION - 10MG/ML
USFDA APPLICATION NUMBER - 87955
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EUROAPI
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ABOUT THIS PAGE
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PharmaCompass offers a list of Vitamin K1 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 Vitamin K1 manufacturer or Vitamin K1 supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vitamin K1 manufacturer or Vitamin K1 supplier.
PharmaCompass also assists you with knowing the Vitamin K1 API Price utilized in the formulation of products. Vitamin K1 API Price is not always fixed or binding as the Vitamin K1 Price is obtained through a variety of data sources. The Vitamin K1 Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fitomenadiona manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fitomenadiona, including repackagers and relabelers. The FDA regulates Fitomenadiona manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fitomenadiona 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 Fitomenadiona manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fitomenadiona supplier is an individual or a company that provides Fitomenadiona active pharmaceutical ingredient (API) or Fitomenadiona finished formulations upon request. The Fitomenadiona suppliers may include Fitomenadiona API manufacturers, exporters, distributors and traders.
click here to find a list of Fitomenadiona suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fitomenadiona DMF (Drug Master File) is a document detailing the whole manufacturing process of Fitomenadiona active pharmaceutical ingredient (API) in detail. Different forms of Fitomenadiona DMFs exist exist since differing nations have different regulations, such as Fitomenadiona USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fitomenadiona DMF submitted to regulatory agencies in the US is known as a USDMF. Fitomenadiona USDMF includes data on Fitomenadiona's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fitomenadiona USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fitomenadiona 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 Fitomenadiona Drug Master File in Japan (Fitomenadiona JDMF) empowers Fitomenadiona 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 Fitomenadiona JDMF during the approval evaluation for pharmaceutical products. At the time of Fitomenadiona 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 Fitomenadiona suppliers with JDMF on PharmaCompass.
A Fitomenadiona CEP of the European Pharmacopoeia monograph is often referred to as a Fitomenadiona Certificate of Suitability (COS). The purpose of a Fitomenadiona CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fitomenadiona EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fitomenadiona to their clients by showing that a Fitomenadiona CEP has been issued for it. The manufacturer submits a Fitomenadiona CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fitomenadiona CEP holder for the record. Additionally, the data presented in the Fitomenadiona CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fitomenadiona DMF.
A Fitomenadiona CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fitomenadiona 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 Fitomenadiona suppliers with CEP (COS) on PharmaCompass.
A Fitomenadiona written confirmation (Fitomenadiona WC) is an official document issued by a regulatory agency to a Fitomenadiona manufacturer, verifying that the manufacturing facility of a Fitomenadiona active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fitomenadiona APIs or Fitomenadiona finished pharmaceutical products to another nation, regulatory agencies frequently require a Fitomenadiona WC (written confirmation) as part of the regulatory process.
click here to find a list of Fitomenadiona 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 Fitomenadiona as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fitomenadiona 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 Fitomenadiona 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 Fitomenadiona and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fitomenadiona NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fitomenadiona suppliers with NDC on PharmaCompass.
Fitomenadiona 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 Fitomenadiona 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 Fitomenadiona GMP manufacturer or Fitomenadiona GMP API supplier for your needs.
A Fitomenadiona CoA (Certificate of Analysis) is a formal document that attests to Fitomenadiona's compliance with Fitomenadiona specifications and serves as a tool for batch-level quality control.
Fitomenadiona CoA mostly includes findings from lab analyses of a specific batch. For each Fitomenadiona 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.
Fitomenadiona may be tested according to a variety of international standards, such as European Pharmacopoeia (Fitomenadiona EP), Fitomenadiona JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fitomenadiona USP).
