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USDMF
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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 - 20MG/ML;0.006...DOSAGE - INJECTABLE;INJECTION - 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML
USFDA APPLICATION NUMBER - 8809
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EUROAPI
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ABOUT THIS PAGE
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PharmaCompass offers a list of Folic Acid 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 Folic Acid manufacturer or Folic Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Folic Acid manufacturer or Folic Acid supplier.
PharmaCompass also assists you with knowing the Folic Acid API Price utilized in the formulation of products. Folic Acid API Price is not always fixed or binding as the Folic Acid Price is obtained through a variety of data sources. The Folic Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Vitamin B9 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vitamin B9, including repackagers and relabelers. The FDA regulates Vitamin B9 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vitamin B9 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 B9 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vitamin B9 supplier is an individual or a company that provides Vitamin B9 active pharmaceutical ingredient (API) or Vitamin B9 finished formulations upon request. The Vitamin B9 suppliers may include Vitamin B9 API manufacturers, exporters, distributors and traders.
click here to find a list of Vitamin B9 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vitamin B9 DMF (Drug Master File) is a document detailing the whole manufacturing process of Vitamin B9 active pharmaceutical ingredient (API) in detail. Different forms of Vitamin B9 DMFs exist exist since differing nations have different regulations, such as Vitamin B9 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vitamin B9 DMF submitted to regulatory agencies in the US is known as a USDMF. Vitamin B9 USDMF includes data on Vitamin B9's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vitamin B9 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vitamin B9 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 B9 Drug Master File in Japan (Vitamin B9 JDMF) empowers Vitamin B9 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 B9 JDMF during the approval evaluation for pharmaceutical products. At the time of Vitamin B9 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 B9 suppliers with JDMF on PharmaCompass.
A Vitamin B9 CEP of the European Pharmacopoeia monograph is often referred to as a Vitamin B9 Certificate of Suitability (COS). The purpose of a Vitamin B9 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Vitamin B9 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Vitamin B9 to their clients by showing that a Vitamin B9 CEP has been issued for it. The manufacturer submits a Vitamin B9 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Vitamin B9 CEP holder for the record. Additionally, the data presented in the Vitamin B9 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Vitamin B9 DMF.
A Vitamin B9 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Vitamin B9 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 B9 suppliers with CEP (COS) on PharmaCompass.
A Vitamin B9 written confirmation (Vitamin B9 WC) is an official document issued by a regulatory agency to a Vitamin B9 manufacturer, verifying that the manufacturing facility of a Vitamin B9 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vitamin B9 APIs or Vitamin B9 finished pharmaceutical products to another nation, regulatory agencies frequently require a Vitamin B9 WC (written confirmation) as part of the regulatory process.
click here to find a list of Vitamin B9 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 B9 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vitamin B9 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 B9 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 B9 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vitamin B9 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vitamin B9 suppliers with NDC on PharmaCompass.
Vitamin B9 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 B9 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 B9 GMP manufacturer or Vitamin B9 GMP API supplier for your needs.
A Vitamin B9 CoA (Certificate of Analysis) is a formal document that attests to Vitamin B9's compliance with Vitamin B9 specifications and serves as a tool for batch-level quality control.
Vitamin B9 CoA mostly includes findings from lab analyses of a specific batch. For each Vitamin B9 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 B9 may be tested according to a variety of international standards, such as European Pharmacopoeia (Vitamin B9 EP), Vitamin B9 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vitamin B9 USP).
