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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

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    01-Jan-2021
    29-Apr-2025
    KGS
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    DRUG PRODUCT COMPOSITIONS

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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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    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

    Folvron Manufacturers

    A Folvron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Folvron, including repackagers and relabelers. The FDA regulates Folvron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Folvron 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 Folvron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Folvron Suppliers

    A Folvron supplier is an individual or a company that provides Folvron active pharmaceutical ingredient (API) or Folvron finished formulations upon request. The Folvron suppliers may include Folvron API manufacturers, exporters, distributors and traders.

    click here to find a list of Folvron suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Folvron USDMF

    A Folvron DMF (Drug Master File) is a document detailing the whole manufacturing process of Folvron active pharmaceutical ingredient (API) in detail. Different forms of Folvron DMFs exist exist since differing nations have different regulations, such as Folvron USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Folvron DMF submitted to regulatory agencies in the US is known as a USDMF. Folvron USDMF includes data on Folvron's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Folvron USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Folvron suppliers with USDMF on PharmaCompass.

    Folvron 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 Folvron Drug Master File in Japan (Folvron JDMF) empowers Folvron 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 Folvron JDMF during the approval evaluation for pharmaceutical products. At the time of Folvron 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 Folvron suppliers with JDMF on PharmaCompass.

    Folvron CEP

    A Folvron CEP of the European Pharmacopoeia monograph is often referred to as a Folvron Certificate of Suitability (COS). The purpose of a Folvron CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Folvron EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Folvron to their clients by showing that a Folvron CEP has been issued for it. The manufacturer submits a Folvron CEP (COS) as part of the market authorization procedure, and it takes on the role of a Folvron CEP holder for the record. Additionally, the data presented in the Folvron CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Folvron DMF.

    A Folvron CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Folvron 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 Folvron suppliers with CEP (COS) on PharmaCompass.

    Folvron WC

    A Folvron written confirmation (Folvron WC) is an official document issued by a regulatory agency to a Folvron manufacturer, verifying that the manufacturing facility of a Folvron active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Folvron APIs or Folvron finished pharmaceutical products to another nation, regulatory agencies frequently require a Folvron WC (written confirmation) as part of the regulatory process.

    click here to find a list of Folvron suppliers with Written Confirmation (WC) on PharmaCompass.

    Folvron 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 Folvron as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Folvron 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 Folvron 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 Folvron and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Folvron NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Folvron suppliers with NDC on PharmaCompass.

    Folvron GMP

    Folvron 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 Folvron 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 Folvron GMP manufacturer or Folvron GMP API supplier for your needs.

    Folvron CoA

    A Folvron CoA (Certificate of Analysis) is a formal document that attests to Folvron's compliance with Folvron specifications and serves as a tool for batch-level quality control.

    Folvron CoA mostly includes findings from lab analyses of a specific batch. For each Folvron 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.

    Folvron may be tested according to a variety of international standards, such as European Pharmacopoeia (Folvron EP), Folvron JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Folvron 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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