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