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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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LTD","supplierCountry":"CHINA","foreign_port":"QINGDAO","customer":"ADITYA CHEMICALS","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"24.8","totalValueFC":"25038.6","currency":"USD","unitRateINR":"2113","date":"12-Nov-2024","totalValueINR":"2112960","totalValueInUsd":"25038.6","indian_port":"Ahmedabad ICD","hs_no":"29362910","bill_no":"6626244","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"QINGDAO","supplierAddress":"ROOM 501-502, TOWER E, YUANJIAN BUI LDING, YUANYANG INTRNATIONAL CENTER , HANGZHOU-310011, CHINA CHINA","customerAddress":"S.F. 204, PRESIDENT PLAZA, OPP-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732732200,"product":"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":"AMSTERDAM, SCHIPHOL","customer":"DSM NUTRITIONAL PRODUCTS INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"750.00","actualQuantity":"750","unit":"KGS","unitRateFc":"12067.9","totalValueFC":"107253.4","currency":"INR","unitRateINR":"12067.9","date":"28-Nov-2024","totalValueINR":"9050917.5","totalValueInUsd":"107253.4","indian_port":"Bombay Air","hs_no":"29362910","bill_no":"6922846","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"AMSTERDAM, SCHIPHOL","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":"Q1","strtotime":1735929000,"product":"VITAMIN MINERAL PREMIX - SAMPLE - NCV - FOR R&D PURPOSE ONLY(1 X 100 G)VITAMIN MINERAL PREMIX - SAMPLE - NCV - FOR R&D PURPOSE ONLY","address":"PLOT NO.3, SURVEYNO.285,VILLAGE MAN","city":"PUNE DIST. MAHARASHTRA","supplier":"DOHLER GMBH","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"DOEHLER INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"42","totalValueFC":"4.2","currency":"USD","unitRateINR":"3636.9","date":"04-Jan-2025","totalValueINR":"363.69","totalValueInUsd":"4.2","indian_port":"Bombay Air","hs_no":"29369000","bill_no":"7620082","productDescription":"R&D Sample","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"RIEDSTRASSE 7-9 D-64295 DARMSTADT G ERMANY Darmstadt - D-64295, Germany Tel.:+49 (0)6151 306-0 Germany","customerAddress":"PLOT NO.3, SURVEYNO.285,VILLAGE MAN"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1736101800,"product":"FOLIC ACID (NOT FOR MEDICINAL USE) FOLIC ACID (NOT FOR MEDICINAL USE)","address":"ROOM NO.34\/B, MANGALDAS BLDG NO.1","city":"MARINE LINES, MUMBAI, M.S.","supplier":"CIDIC HOLDING CO LTD","supplierCountry":"CAMBODIA","foreign_port":"LAEM CHABANG","customer":"MINERVA BIOGENIX PRIVATE LTD","customerCountry":"INDIA","quantity":"4500.00","actualQuantity":"4500","unit":"KGS","unitRateFc":"25.5","totalValueFC":"115243.4","currency":"USD","unitRateINR":"2208.3","date":"06-Jan-2025","totalValueINR":"9937350","totalValueInUsd":"115243.4","indian_port":"JNPT","hs_no":"29362910","bill_no":"7643376","productDescription":"API","marketType":"","country":"CAMBODIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LAEM CHABANG","supplierAddress":"RM-1002,10\/F,EASEY COMM BLDG 253-261 HENNESSY ROAD WANCHAI HONGKONG HK","customerAddress":"ROOM NO.34\/B, MANGALDAS BLDG NO.1"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741717800,"product":"FOLIC ACID 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":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"46.5","totalValueFC":"47134.8","currency":"USD","unitRateINR":"4082.7","date":"12-Mar-2025","totalValueINR":"4082700","totalValueInUsd":"47134.8","indian_port":"Madras-EPZ\/SEZ","hs_no":"29362910","bill_no":"8844381","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":1748457000,"product":"FOLIC ACID FOLIC ACID","address":"PLOT.NO.49,CANARA BANK ROAD,","city":"PHASE-I,BANGALORE","supplier":"JIANGXI TIANXIN PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"ANTHEM BIOSCIENCES LTD","customerCountry":"INDIA","quantity":"2500.00","actualQuantity":"2500","unit":"KGS","unitRateFc":"55.7","totalValueFC":"141103","currency":"USD","unitRateINR":"4808.8","date":"29-May-2025","totalValueINR":"12022071","totalValueInUsd":"141103","indian_port":"Madras Sea","hs_no":"29362910","bill_no":"2343138","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"LEPING INDUSTRIAL ZONE, LEPING, JIA NGXI 333300, CHINA JIANGXI - 333300 , , CHINA CHINA","customerAddress":"PLOT.NO.49,CANARA BANK ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753295400,"product":"FOLIC ACID (NOT FOR MEDICINAL USE) BATCH NO : FA25052505 FOLIC ACID NOT FOR MEDICINAL USE BATCH NO : FA25012004","address":"25 BUNDER STREET","city":"CHENNAI","supplier":"JIANGXI TIANXIN PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"PANVO ORGANICS PRIVATE LTD","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"62.1","totalValueFC":"31291.3","currency":"USD","unitRateINR":"5386.2","date":"24-Jul-2025","totalValueINR":"2693119","totalValueInUsd":"31291.3","indian_port":"Madras Sea","hs_no":"29362910","bill_no":"3461810","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"LEPING INDUSTRIAL ZONE LEPING JIAN GXI 333300 CHINA, , CHINA SDNF CHINA","customerAddress":"25 BUNDER STREET"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1754505000,"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":"SHANGHAI","customer":"MC COY DRUGS PRIVATE LTD","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"44","totalValueFC":"43660.3","currency":"USD","unitRateINR":"3821.1","date":"07-Aug-2025","totalValueINR":"3821136.28","totalValueInUsd":"43660.3","indian_port":"Surat-EPZ\/SEZ","hs_no":"29362910","bill_no":"3740559","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"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":1762194600,"product":"FOLIC ACID VITAMIN B1 MONO(THIAMINE MONONITRATE)","address":"PLOT NO.B11, PHASE-1, MEPZ-SEZ,","city":"CHENNAI, TAMIL NADU","supplier":"SINOCO CHEMICAL CO LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"HEXAGON NUTRITION EXPORTS PRIVATE LTD","customerCountry":"INDIA","quantity":"4000.00","actualQuantity":"4000","unit":"KGS","unitRateFc":"43","totalValueFC":"171649.8","currency":"USD","unitRateINR":"3814.1","date":"04-Nov-2025","totalValueINR":"15256400","totalValueInUsd":"171649.8","indian_port":"Madras-EPZ\/SEZ","hs_no":"29362910","bill_no":"1","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":"Q4","strtotime":1763317800,"product":"FOLIC ACID (TECHNICAL GRADE) - BATCH NO. 04251047 (AS PER INV & PL)FOLIC ACID (TECHNICAL GRADE) - BATCH NO. 04251047 (AS PER IN","address":"N\/A","city":"","supplier":"LUCKY STEP CORP LTD","supplierCountry":"CHINA","foreign_port":"NANJING","customer":"PUSHTI EXIM","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"30.9","totalValueFC":"31115.2","currency":"USD","unitRateINR":"2765.6","date":"17-Nov-2025","totalValueINR":"2765550","totalValueInUsd":"31115.2","indian_port":"Ahmedabad Air","hs_no":"29362910","bill_no":"48","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NANJING","supplierAddress":"FLAT\/RM 2108, 21\/F, CC WU BUILDING, 302-308 HENNESSY ROAD, WAN CHAI, H ONG KONG Hong Kong, , HONG KONG HONG KONG","customerAddress":"N\/A"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1767810600,"product":"VITAMIN MIX PDR;013114\/002(SAMPLE - NCV -TRIAL PURPOSE) VITAMIN MIX PDR013114\/002(SAMPLE - NCV -TRIAL PURPOSE)","address":"PLOT NO.26,2ND CROSS,JIGANI","city":"BANGALORE","supplier":"GIVAUDAN SOUTH AFRICA (PTY) LTD.","supplierCountry":"SOUTH AFRICA","foreign_port":"JOHANNESBURG - JOHAN","customer":"GIVAUDAN INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"0.20","actualQuantity":"0.2","unit":"KGS","unitRateFc":"82.6","totalValueFC":"16.5","currency":"INR","unitRateINR":"7500","date":"08-Jan-2026","totalValueINR":"1500","totalValueInUsd":"16.5","indian_port":"Bombay Air","hs_no":"29369000","bill_no":"51","productDescription":"R&D Sample","marketType":"","country":"SOUTH AFRICA","selfForZScoreResived":"Pharma Grade","supplierPort":"JOHANNESBURG - JOHAN","supplierAddress":"9-11 BRUNEL ROAD, 2197 JOHANNESBURG SDNF SOUTH AFRICA","customerAddress":"PLOT NO.26,2ND CROSS,JIGANI"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1771785000,"product":"FOLIC ACID (NOT FOR MEDICINAL USE)","address":"A\/403,ANJANI COMPLEX","city":"ANDHERI (EAST),MUMBAI","supplier":"NINGBO HITECH BIOCHEMICALS CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"MC COY DRUGS PVT LTD","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"37","totalValueFC":"74922.2","currency":"USD","unitRateINR":"3400.3","date":"23-Feb-2026","totalValueINR":"6800600","totalValueInUsd":"74922.2","indian_port":"Surat-EPZ\/SEZ","hs_no":"29362910","bill_no":"6503175","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"N\/A","customerAddress":"A\/403,ANJANI COMPLEX"}]
11-Jan-2022
23-Feb-2026
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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

25

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

Apo-Folic Manufacturers

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

Apo-Folic Suppliers

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

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

Apo-Folic USDMF

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

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

click here to find a list of Apo-Folic suppliers with USDMF on PharmaCompass.

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

Apo-Folic CEP

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

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

Apo-Folic WC

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

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

Apo-Folic 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 Apo-Folic as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Apo-Folic suppliers with NDC on PharmaCompass.

Apo-Folic GMP

Apo-Folic 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 Apo-Folic 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 Apo-Folic GMP manufacturer or Apo-Folic GMP API supplier for your needs.

Apo-Folic CoA

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

Apo-Folic CoA mostly includes findings from lab analyses of a specific batch. For each Apo-Folic 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.

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