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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
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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 01769_FLUKA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 01769_FLUKA, including repackagers and relabelers. The FDA regulates 01769_FLUKA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 01769_FLUKA 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 01769_FLUKA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 01769_FLUKA supplier is an individual or a company that provides 01769_FLUKA active pharmaceutical ingredient (API) or 01769_FLUKA finished formulations upon request. The 01769_FLUKA suppliers may include 01769_FLUKA API manufacturers, exporters, distributors and traders.
click here to find a list of 01769_FLUKA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 01769_FLUKA DMF (Drug Master File) is a document detailing the whole manufacturing process of 01769_FLUKA active pharmaceutical ingredient (API) in detail. Different forms of 01769_FLUKA DMFs exist exist since differing nations have different regulations, such as 01769_FLUKA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 01769_FLUKA DMF submitted to regulatory agencies in the US is known as a USDMF. 01769_FLUKA USDMF includes data on 01769_FLUKA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 01769_FLUKA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 01769_FLUKA 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 01769_FLUKA Drug Master File in Japan (01769_FLUKA JDMF) empowers 01769_FLUKA 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 01769_FLUKA JDMF during the approval evaluation for pharmaceutical products. At the time of 01769_FLUKA 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 01769_FLUKA suppliers with JDMF on PharmaCompass.
A 01769_FLUKA CEP of the European Pharmacopoeia monograph is often referred to as a 01769_FLUKA Certificate of Suitability (COS). The purpose of a 01769_FLUKA CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 01769_FLUKA EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 01769_FLUKA to their clients by showing that a 01769_FLUKA CEP has been issued for it. The manufacturer submits a 01769_FLUKA CEP (COS) as part of the market authorization procedure, and it takes on the role of a 01769_FLUKA CEP holder for the record. Additionally, the data presented in the 01769_FLUKA CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 01769_FLUKA DMF.
A 01769_FLUKA CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 01769_FLUKA 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 01769_FLUKA suppliers with CEP (COS) on PharmaCompass.
A 01769_FLUKA written confirmation (01769_FLUKA WC) is an official document issued by a regulatory agency to a 01769_FLUKA manufacturer, verifying that the manufacturing facility of a 01769_FLUKA active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 01769_FLUKA APIs or 01769_FLUKA finished pharmaceutical products to another nation, regulatory agencies frequently require a 01769_FLUKA WC (written confirmation) as part of the regulatory process.
click here to find a list of 01769_FLUKA 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 01769_FLUKA as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 01769_FLUKA 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 01769_FLUKA 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 01769_FLUKA and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 01769_FLUKA NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 01769_FLUKA suppliers with NDC on PharmaCompass.
01769_FLUKA 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 01769_FLUKA 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 01769_FLUKA GMP manufacturer or 01769_FLUKA GMP API supplier for your needs.
A 01769_FLUKA CoA (Certificate of Analysis) is a formal document that attests to 01769_FLUKA's compliance with 01769_FLUKA specifications and serves as a tool for batch-level quality control.
01769_FLUKA CoA mostly includes findings from lab analyses of a specific batch. For each 01769_FLUKA 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.
01769_FLUKA may be tested according to a variety of international standards, such as European Pharmacopoeia (01769_FLUKA EP), 01769_FLUKA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (01769_FLUKA USP).
