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    Chemistry

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    Also known as:
    Molecular Formula
    C19H19N7O6
    Molecular Weight
    441.4  g/mol
    InChI Key
    OVBPIULPVIDEAO-LBPRGKRZSA-N
    Folic Acid
    1 2D Structure

    Folic Acid

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S)-2-[[4-[(2-amino-4-oxo-1H-pteridin-6-yl)methylamino]benzoyl]amino]pentanedioic acid
    2.1.2 InChI
    InChI=1S/C19H19N7O6/c20-19-25-15-14(17(30)26-19)23-11(8-22-15)7-21-10-3-1-9(2-4-10)16(29)24-12(18(31)32)5-6-13(27)28/h1-4,8,12,21H,5-7H2,(H,24,29)(H,27,28)(H,31,32)(H3,20,22,25,26,30)/t12-/m0/s1
    2.1.3 InChI Key
    OVBPIULPVIDEAO-LBPRGKRZSA-N
    2.1.4 Canonical SMILES
    C1=CC(=CC=C1C(=O)NC(CCC(=O)O)C(=O)O)NCC2=CN=C3C(=N2)C(=O)N=C(N3)N
    2.1.5 Isomeric SMILES
    C1=CC(=CC=C1C(=O)N[C@@H](CCC(=O)O)C(=O)O)NCC2=CN=C3C(=N2)C(=O)N=C(N3)N
    2.2 Create Date
    2004-09-16
    3 Chemical and Physical Properties
    Molecular Weight 441.4 g/mol
    Molecular Formula C19H19N7O6
    XLogP3-1.1
    Hydrogen Bond Donor Count6
    Hydrogen Bond Acceptor Count9
    Rotatable Bond Count9
    Exact Mass441.13968135 g/mol
    Monoisotopic Mass441.13968135 g/mol
    Topological Polar Surface Area209 Ų
    Heavy Atom Count32
    Formal Charge0
    Complexity767
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameFolic acid
    PubMed HealthFolic Acid
    Drug ClassesNutriceutical, Nutritive Agent
    Drug LabelFolic acid, N-[p-[[(2-amino-4-hydroxy-6-pteridiny)methyl]amino]benzoyl]-L-glutamic acid, is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para-aminobenzoic acid, which is joined by a peptide linkage to glutamic aci...
    Active IngredientFolic acid
    Dosage FormTablet; Injectable
    RouteInjection; Oral
    Strength1 mg; 1mg; 5mg/ml
    Market StatusPrescription
    CompanyBicon Pharm; Excellium; Jubilant Cadista; Cadila Pharms; Invagen Pharms; Hikma Pharms; Watson Labs; Amneal Pharm; Fresenius Kabi Usa; Vintage; Contract Pharmacal

    2 of 2  
    Drug NameFolic acid
    PubMed HealthFolic Acid
    Drug ClassesNutriceutical, Nutritive Agent
    Drug LabelFolic acid, N-[p-[[(2-amino-4-hydroxy-6-pteridiny)methyl]amino]benzoyl]-L-glutamic acid, is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para-aminobenzoic acid, which is joined by a peptide linkage to glutamic aci...
    Active IngredientFolic acid
    Dosage FormTablet; Injectable
    RouteInjection; Oral
    Strength1 mg; 1mg; 5mg/ml
    Market StatusPrescription
    CompanyBicon Pharm; Excellium; Jubilant Cadista; Cadila Pharms; Invagen Pharms; Hikma Pharms; Watson Labs; Amneal Pharm; Fresenius Kabi Usa; Vintage; Contract Pharmacal

    API Reference Price

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    02-Jan-2021
    29-Apr-2025
    KGS
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    API Imports and Exports

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    Europe

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    01

    Andreabal AG

    Switzerland
    American Thoracic Society
    Not Confirmed
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    Andreabal AG

    Switzerland
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    American Thoracic Society
    Not Confirmed
    • fda
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    Regulatory Info :

    Registration Country : Switzerland

    Ferrum(II) ionisatum; Acidum folicum; Acidum ascorbicum (Vitamin C; E300)

    Brand Name : Duofer Fol

    Dosage Form : Filmtabl

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    Packaging :

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    Regulatory Info :

    Registration Country : Switzerland

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    EFFIK ITALIA SPA

    Italy
    American Thoracic Society
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    Italy
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    Regulatory Info :

    Registration Country : Italy

    Folic acid

    Brand Name : FERTIFOL

    Dosage Form : Tablets

    Dosage Strength : 400mcg

    Packaging : 120 UNITS 400 MCG - ORAL USE

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    EG SPA

    Italy
    American Thoracic Society
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    EG SPA

    Italy
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    Registration Country : Italy

    Folic acid

    Brand Name : FOLIC ACID EG

    Dosage Form : Tablets

    Dosage Strength : 5 mg

    Packaging : 60 UNITS 5 MG - ORAL USE

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    FRESENIUS KABI ITALIA Srl

    Sweden
    American Thoracic Society
    Not Confirmed
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    FRESENIUS KABI ITALIA Srl

    Sweden
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    American Thoracic Society
    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    Riboflavin; Disodium Hydrogen Phosphate; Niacinamide; Pyridoxine Hydrochloride; Pantothenic Acid; Ascorbic Acid; Biotin; Folic Acid; Vitamin B 12

    Brand Name : Soluvit

    Dosage Form : Thiamin Riboflav+.+Sodium Phosph.+Nicotinam.+Piridoss.+Ac.Pantoten.+Ac.Ascorb.+Biotin+Ac.Folic Cianocobal+.10Ml 10 Units

    Dosage Strength : "AD" 10 VIALS EV 10 ml

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Laboratórios Basi

    Portugal
    American Thoracic Society
    Not Confirmed
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    Registration Country : Portugal

    Thiamine; Riboflavin; Niacin; Pantothenic Acid; Pyridoxine; Vitamin B 12; Biotin; Folic Acid

    Brand Name :

    Dosage Form : Liquid Solution

    Dosage Strength :

    Packaging : 1 Bottle- 100 ML

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Portugal

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    Laboratórios Basi

    Portugal
    American Thoracic Society
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    Registration Country : Portugal

    Iron; Thiamine; Riboflavin; Niacin; Pyridoxine; Vitamin B 12; Folic Acid

    Brand Name :

    Dosage Form : Liquid Solution

    Dosage Strength :

    Packaging : 1 Bottle- 200 ML

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Portugal

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    Pfizer

    U.S.A
    American Thoracic Society
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    U.S.A
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    Regulatory Info :

    Registration Country : Sweden

    folic acid (hydrated)

    Brand Name : folacin

    Dosage Form : TABLET

    Dosage Strength : 5 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    Pierre Fabre Pharma AG

    France
    American Thoracic Society
    Not Confirmed
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    Pierre Fabre Pharma AG

    France
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    Regulatory Info :

    Registration Country : Switzerland

    Ferrum(II) ionisatum; Acidum folicum

    Brand Name : Gyno-Tardyferon

    Dosage Form : Ret Tabl

    Dosage Strength :

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    TEOFARMA SRL

    Italy
    American Thoracic Society
    Not Confirmed
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    TEOFARMA SRL

    Italy
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    Regulatory Info :

    Registration Country : Italy

    Folic acid

    Brand Name : FOLINA

    Dosage Form : Soft Capsules

    Dosage Strength : 5 mg

    Packaging : 120 UNITS 5 MG - ORAL USE

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    Vefa Ilac

    Turkey
    American Thoracic Society
    Not Confirmed
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    Turkey
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    Regulatory Info : Generic

    Registration Country : Turkey

    Folic Acid

    Brand Name : Pregniofol

    Dosage Form : TABLET

    Dosage Strength :

    Packaging : 90 Tablets

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : Turkey

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    Only 10 entries up to this point, click to access all click full view read-more
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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

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    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

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    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

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    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

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    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

    Looking for / Folic Acid API manufacturers, exporters & distributors?

    Folic Acid manufacturers, exporters & distributors 1

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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.

    API | Excipient name

    Folic Acid

    Folvite Manufacturers

    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.

    Folvite Suppliers

    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.

    Folvite USDMF

    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.

    Folvite JDMF

    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.

    Folvite CEP

    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.

    Folvite WC

    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.

    Folvite NDC

    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).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Folvite API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    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.

    Compounded drug products

    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 GMP

    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.

    Folvite CoA

    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).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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