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API SUPPLIERS
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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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ABOUT THIS PAGE
21
PharmaCompass offers a list of Folic Acid API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.
A Megafol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Megafol, including repackagers and relabelers. The FDA regulates Megafol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Megafol 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 Megafol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Megafol supplier is an individual or a company that provides Megafol active pharmaceutical ingredient (API) or Megafol finished formulations upon request. The Megafol suppliers may include Megafol API manufacturers, exporters, distributors and traders.
click here to find a list of Megafol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Megafol DMF (Drug Master File) is a document detailing the whole manufacturing process of Megafol active pharmaceutical ingredient (API) in detail. Different forms of Megafol DMFs exist exist since differing nations have different regulations, such as Megafol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Megafol DMF submitted to regulatory agencies in the US is known as a USDMF. Megafol USDMF includes data on Megafol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Megafol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Megafol 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 Megafol Drug Master File in Japan (Megafol JDMF) empowers Megafol 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 Megafol JDMF during the approval evaluation for pharmaceutical products. At the time of Megafol 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 Megafol suppliers with JDMF on PharmaCompass.
A Megafol CEP of the European Pharmacopoeia monograph is often referred to as a Megafol Certificate of Suitability (COS). The purpose of a Megafol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Megafol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Megafol to their clients by showing that a Megafol CEP has been issued for it. The manufacturer submits a Megafol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Megafol CEP holder for the record. Additionally, the data presented in the Megafol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Megafol DMF.
A Megafol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Megafol 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 Megafol suppliers with CEP (COS) on PharmaCompass.
A Megafol written confirmation (Megafol WC) is an official document issued by a regulatory agency to a Megafol manufacturer, verifying that the manufacturing facility of a Megafol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Megafol APIs or Megafol finished pharmaceutical products to another nation, regulatory agencies frequently require a Megafol WC (written confirmation) as part of the regulatory process.
click here to find a list of Megafol 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 Megafol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Megafol 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 Megafol 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 Megafol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Megafol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Megafol suppliers with NDC on PharmaCompass.
Megafol 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 Megafol GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Megafol GMP manufacturer or Megafol GMP API supplier for your needs.
A Megafol CoA (Certificate of Analysis) is a formal document that attests to Megafol's compliance with Megafol specifications and serves as a tool for batch-level quality control.
Megafol CoA mostly includes findings from lab analyses of a specific batch. For each Megafol 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.
Megafol may be tested according to a variety of international standards, such as European Pharmacopoeia (Megafol EP), Megafol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Megafol USP).
