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DRUG PRODUCT COMPOSITIONS0
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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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Drugs in Development
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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**Federal Register...DOSAGE - TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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***Fe...DOSAGE - INJECTABLE;INJECTION - 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**F...DOSAGE - INJECTABLE;INJECTION - 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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ABOUT THIS PAGE
A Vitamin K1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vitamin K1, including repackagers and relabelers. The FDA regulates Vitamin K1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vitamin K1 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 Vitamin K1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vitamin K1 supplier is an individual or a company that provides Vitamin K1 active pharmaceutical ingredient (API) or Vitamin K1 finished formulations upon request. The Vitamin K1 suppliers may include Vitamin K1 API manufacturers, exporters, distributors and traders.
click here to find a list of Vitamin K1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vitamin K1 DMF (Drug Master File) is a document detailing the whole manufacturing process of Vitamin K1 active pharmaceutical ingredient (API) in detail. Different forms of Vitamin K1 DMFs exist exist since differing nations have different regulations, such as Vitamin K1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vitamin K1 DMF submitted to regulatory agencies in the US is known as a USDMF. Vitamin K1 USDMF includes data on Vitamin K1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vitamin K1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vitamin K1 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 Vitamin K1 Drug Master File in Japan (Vitamin K1 JDMF) empowers Vitamin K1 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 Vitamin K1 JDMF during the approval evaluation for pharmaceutical products. At the time of Vitamin K1 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 Vitamin K1 suppliers with JDMF on PharmaCompass.
A Vitamin K1 CEP of the European Pharmacopoeia monograph is often referred to as a Vitamin K1 Certificate of Suitability (COS). The purpose of a Vitamin K1 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Vitamin K1 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Vitamin K1 to their clients by showing that a Vitamin K1 CEP has been issued for it. The manufacturer submits a Vitamin K1 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Vitamin K1 CEP holder for the record. Additionally, the data presented in the Vitamin K1 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Vitamin K1 DMF.
A Vitamin K1 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Vitamin K1 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 Vitamin K1 suppliers with CEP (COS) on PharmaCompass.
A Vitamin K1 written confirmation (Vitamin K1 WC) is an official document issued by a regulatory agency to a Vitamin K1 manufacturer, verifying that the manufacturing facility of a Vitamin K1 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vitamin K1 APIs or Vitamin K1 finished pharmaceutical products to another nation, regulatory agencies frequently require a Vitamin K1 WC (written confirmation) as part of the regulatory process.
click here to find a list of Vitamin K1 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 Vitamin K1 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vitamin K1 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 Vitamin K1 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 Vitamin K1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vitamin K1 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vitamin K1 suppliers with NDC on PharmaCompass.
Vitamin K1 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 Vitamin K1 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 Vitamin K1 GMP manufacturer or Vitamin K1 GMP API supplier for your needs.
A Vitamin K1 CoA (Certificate of Analysis) is a formal document that attests to Vitamin K1's compliance with Vitamin K1 specifications and serves as a tool for batch-level quality control.
Vitamin K1 CoA mostly includes findings from lab analyses of a specific batch. For each Vitamin K1 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.
Vitamin K1 may be tested according to a variety of international standards, such as European Pharmacopoeia (Vitamin K1 EP), Vitamin K1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vitamin K1 USP).
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