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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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ASPEN COURT,R A","city":"CHENNAI,TAMIL NADU","supplier":"ZHEJIANG SHENGDA BIO PHARMA CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"TROUW NUTRITION INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"40","totalValueFC":"40660.5","currency":"USD","unitRateINR":"3536","date":"15-Feb-2025","totalValueINR":"3536000","totalValueInUsd":"40660.5","indian_port":"JNPT","hs_no":"29362990","bill_no":"8373000","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO. 789, RENMIN EAST ROAD, TIANTAI, ZHEJIANG . - 317200, , CHINA SDNF CHINA","customerAddress":"III FLOOR NO.39\/19 ASPEN COURT,R A"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747247400,"product":"FOLIC ACID (NOT FOR MEDICINAL USE) NA","address":"25D, Basant Vihar,","city":"Agra","supplier":"AMS CHINA HK COLIMITED CO","supplierCountry":"CHINA","foreign_port":"HONG KONG","customer":"RADHASHOK PHARMACHEM PRIVATE LTD","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"37","totalValueFC":"37151.7","currency":"USD","unitRateINR":"3165.4","date":"15-May-2025","totalValueINR":"3165350","totalValueInUsd":"37151.7","indian_port":"Delhi Air","hs_no":"29309099","bill_no":"2060552","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HONG KONG","supplierAddress":"UNIT 1406A,14\/F,THE BELGIAN BANK BUILDING,NOS.721 -725 NATHAN ROAD KOWLOON,HONGKONG, CHINA","customerAddress":"25D, Basant Vihar,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747247400,"product":"FOLIC ACID FOR BIOCHEMISTRY 1PCS X 25G (PHARMA GRADE) ORGANIC CHEMICAL","address":"50A , RING ROAD,","city":"BANGALORE, KARNATAKA","supplier":"MERCK LIFE SCIENCE KGAA","supplierCountry":"INDIA","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"MERCK LIFE SCIENCE PRIVATE LTD","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"0.025","unit":"KGS","unitRateFc":"3074.5","totalValueFC":"77.2","currency":"INR","unitRateINR":"263025.2","date":"15-May-2025","totalValueINR":"6575.63","totalValueInUsd":"77.2","indian_port":"Bombay Air","hs_no":"29362990","bill_no":"2068410","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"Frankfurter Strasse 25064293 Darmst adt Germany (BENEFICIARY MERCKFINA NCIAL SERVICES GMBH) GERMANY","customerAddress":"50A , RING ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748025000,"product":"VITAMIN B1 MONO FOLIC ACID","address":"PLOT NO.B11, PHASE-1, MEPZ-SEZ,","city":"CHENNAI, TAMIL NADU","supplier":"SINCO CHEMICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"HEXAGON NUTRITION EXPORTS PRIVATE LTD","customerCountry":"INDIA","quantity":"3000.00","actualQuantity":"3000","unit":"KGS","unitRateFc":"31","totalValueFC":"94309.1","currency":"USD","unitRateINR":"2678.4","date":"24-May-2025","totalValueINR":"8035200","totalValueInUsd":"94309.1","indian_port":"Madras-EPZ\/SEZ","hs_no":"29362210","bill_no":"2257286","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"TRUST COMPANY COMPLEX AJELTAKE ROAD AJELTAKE ISLAND MAJURO MHL SDNF CHINA","customerAddress":"PLOT NO.B11, PHASE-1, MEPZ-SEZ,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750357800,"product":"FOLIC ACID FCC GRADE FOLIC ACID FCC GRADE","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"JIANGXI TIANXIN PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"PIRAMAL PHARMA LTD","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"63.7","totalValueFC":"32502.8","currency":"USD","unitRateINR":"5585.6","date":"20-Jun-2025","totalValueINR":"2792819.56","totalValueInUsd":"32502.8","indian_port":"JNPT","hs_no":"29362910","bill_no":"2770028","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"LEPING INDUSTRIAL ZONE, LEPING, JIA NGXI 333300 CHINA SDNF China","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1754418600,"product":"FOLIC ACID FOOD GRADE -SWITZERLAND FOLIC ACID FOOD GRADE -SWITZERLAND","address":"401 4TH FL WINDSOR HOUSE CST RD","city":"MUMBAI, MAHARASHTRA.","supplier":"DSM NUTRITIONAL PRODUCTS ASIA PACIFIC","supplierCountry":"SWITZERLAND","foreign_port":"ROTTERDAM","customer":"DSM NUTRITIONAL PRODUCTS INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"375.00","actualQuantity":"375","unit":"KGS","unitRateFc":"34.7","totalValueFC":"12895.7","currency":"N\/A","unitRateINR":"3009.7","date":"06-Aug-2025","totalValueINR":"1128630","totalValueInUsd":"12895.7","indian_port":"JNPT","hs_no":"29362910","bill_no":"3712325","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"ROTTERDAM","supplierAddress":"30 PASIR PANJANG ROAD #13-31, MAPLE TREE BUSINESS CITY, Singapore - 117 440, , Singapore Singapore","customerAddress":"401 4TH FL WINDSOR HOUSE CST RD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1754418600,"product":"FOLIC ACID(NOT FOR MEDICINAL USE) FOLIC ACID(NOT FOR MEDICINAL USE)","address":"NO.11, NYNIAPPA NAICK STREET","city":"CHENNAI","supplier":"YOUYANG CO LTD","supplierCountry":"CAMBODIA","foreign_port":"PHNOM PENH","customer":"S KESARIMAL","customerCountry":"INDIA","quantity":"1020.00","actualQuantity":"1020","unit":"KGS","unitRateFc":"37","totalValueFC":"37429.7","currency":"USD","unitRateINR":"3211.6","date":"06-Aug-2025","totalValueINR":"3275832","totalValueInUsd":"37429.7","indian_port":"Madras Sea","hs_no":"29362910","bill_no":"3714416","productDescription":"API","marketType":"","country":"CAMBODIA","selfForZScoreResived":"Pharma Grade","supplierPort":"PHNOM PENH","supplierAddress":"UNIT 1002, 10\/F, PERFECT COMM BLDG 20 AUSTIN AVENUE TSIM SHA TSUI HONG KONG HK","customerAddress":"NO.11, NYNIAPPA NAICK STREET"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1754505000,"product":"FOLIC ACID (FOR R&D PURPOSE) FOLIC ACID","address":"27\/1025A,G-285","city":"ERNAKULAM,KERALA","supplier":"WONDER INGREDIENTS COLTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AUREA BIOLABS PRIVATE LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"36.5","totalValueFC":"36.2","currency":"USD","unitRateINR":"3168.2","date":"07-Aug-2025","totalValueINR":"3168.2","totalValueInUsd":"36.2","indian_port":"Cochin Air","hs_no":"29362910","bill_no":"3734530","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"ROOM 198,NO601-603,BUILDING 3VANKE JINYU HUAFU,NO 539 WANJIALI HUAFU MIDDLE ROAD CHANGSHA CHINA CN","customerAddress":"27\/1025A,G-285"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1764009000,"product":"FOLIC ACID (NOT FOR MEDICINAL USE)","address":"A\/403,ANJANI COMPLEX","city":"ANDHERI (EAST),MUMBAI","supplier":"NINGBO HI TECH BIOCHEMICALS CO LTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"MC COY DRUGS PRIVATE LTD","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"32.5","totalValueFC":"16363.2","currency":"USD","unitRateINR":"2908.8","date":"25-Nov-2025","totalValueINR":"1454375","totalValueInUsd":"16363.2","indian_port":"Surat-EPZ\/SEZ","hs_no":"29362910","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"Room 602,One Culture Plaza No.1349 LiYuan North Road, Ningbo SDNF China","customerAddress":"A\/403,ANJANI COMPLEX"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1765823400,"product":"FOLIC ACID (NOT FOR MEDICAL USE) FOLIC ACID (NOT FOR MEDICAL USE)","address":"25D, Basant Vihar,","city":"Agra","supplier":"NANCHANG RENFERT BIOTECH CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"RADHASHOK PHARMACHEM PRIVATE LTD","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"28","totalValueFC":"56808.3","currency":"USD","unitRateINR":"2556.4","date":"16-Dec-2025","totalValueINR":"5112800","totalValueInUsd":"56808.3","indian_port":"Delhi PPG ICD","hs_no":"29419090","bill_no":"1","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"RM. 2234, BUILDING 15&16, HUAPENG D ONGAN 988 ZIYANG AVENUE, HIGH TECH ZONE, NANCHANG CITY, JIANGXI PROVIN China","customerAddress":"25D, Basant Vihar,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1766687400,"product":"FOLIC ACID PH - SWITZERLAND (FOR MEDICINAL USE) FOLIC ACID PH - (FOR MEDICINAL USE)SWITZERLAND","address":"401 4TH FL WINDSOR HOUSE CST RD","city":"MUMBAI, MAHARASHTRA.","supplier":"DSM NUTRITIONAL PRODUCTS ASIA PACIFIC","supplierCountry":"SWITZERLAND","foreign_port":"ROTTERDAM","customer":"DSM NUTRITIONAL PRODUCTS INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"134.6","totalValueFC":"273019.5","currency":"N\/A","unitRateINR":"12286","date":"26-Dec-2025","totalValueINR":"24572000","totalValueInUsd":"273019.5","indian_port":"JNPT","hs_no":"29362910","bill_no":"412788","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"ROTTERDAM","supplierAddress":"30 PASIR PANJANG ROAD #13-31, MAPLE TREE BUSINESS CITY, Singapore - 117 440, , Singapore Singapore","customerAddress":"401 4TH FL WINDSOR HOUSE CST RD"}]
    03-Feb-2022
    26-Dec-2025
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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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    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

    Foldine Manufacturers

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

    Foldine Suppliers

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

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

    Foldine USDMF

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

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

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

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

    Foldine CEP

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

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

    Foldine WC

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

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

    Foldine 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 Foldine as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Foldine GMP

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

    Foldine CoA

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

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

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