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