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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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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":1737052200,"product":"FOLIC ACID PH - SWITZERLAND FOLIC ACID PH - 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":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"157.2","totalValueFC":"635.2","currency":"INR","unitRateINR":"13693.1","date":"17-Jan-2025","totalValueINR":"54772.52","totalValueInUsd":"635.2","indian_port":"Bombay Air","hs_no":"29362910","bill_no":"7828478","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":1737138600,"product":"FOLIC ACID NOT FOR MEDICINAL USE BATCH NO : FA24112018 FOLIC ACID NOT FOR MEDICINAL USE BATCH NO : FA24102015","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":"30.2","totalValueFC":"15235","currency":"USD","unitRateINR":"2627.4","date":"18-Jan-2025","totalValueINR":"1313705","totalValueInUsd":"15235","indian_port":"Madras Sea","hs_no":"29362910","bill_no":"7852543","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":"Q1","strtotime":1739989800,"product":"FOLIC ACID 96% FEED GRADE (NOT FOR HUMAN\/MEDICINAL USE,FOR USE IN ANIMAL FEED ONLY)FOLIC ACID 96% FEED GRADE","address":"IS.40 KHB INDUSTRIAL AREA","city":"BANGALORE ,KARNATAKA","supplier":"CARGILL INTERNATIONAL S A","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"PROVIMI ANIMAL NUTRITION INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"25.3","totalValueFC":"5153.6","currency":"USD","unitRateINR":"2240.9","date":"20-Feb-2025","totalValueINR":"448177.54","totalValueInUsd":"5153.6","indian_port":"Madras Sea","hs_no":"29362910","bill_no":"8473604","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"ESPLANADE DE PONT-ROUGE 4 , CH-1212 GRAND-LANCY GENEVE CH","customerAddress":"IS.40 KHB INDUSTRIAL AREA"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740421800,"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":"CHINA","foreign_port":"BANGKOK","customer":"MINERVA BIOGENIX PRIVATE LTD","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"34.3","totalValueFC":"34578.6","currency":"USD","unitRateINR":"3007.1","date":"25-Feb-2025","totalValueINR":"3007100","totalValueInUsd":"34578.6","indian_port":"JNPT","hs_no":"29362910","bill_no":"8562098","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BANGKOK","supplierAddress":"RM 1002,10\/F ,EASEY COMM BLDG 253- 261,HENNESSY ROAD, WANCHAI HONG KON G China","customerAddress":"ROOM NO.34\/B, MANGALDAS BLDG NO.1"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744569000,"product":"FOLIC ACID FCC GRADE FOLIC ACID FCC GRADE","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"JIANGXI TIANXIN PHARMACEUTICAL COLTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"PIRAMAL PHARMA LTD","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"66.4","totalValueFC":"33580","currency":"USD","unitRateINR":"5749","date":"14-Apr-2025","totalValueINR":"2874511.64","totalValueInUsd":"33580","indian_port":"Bombay Air","hs_no":"29362990","bill_no":"9481151","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"LEPING INDUSTRIAL ZONE, LEPING, JIA NGXI 333300, CHINA Jiangxi, , China SDNF China","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746815400,"product":"FOLIC ACID (NOT FOR MEDICINAL USE) FOLIC ACID (NOT FOR MEDICINAL USE)","address":"EI-362-363-364 SITAPURA INDL. AREA,","city":"JAIPUR","supplier":"ACI BIOTECH IMPORT AND EXPORT CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"AMOL PHARMACEUTICALS PRIVATE LTD","customerCountry":"INDIA","quantity":"80.00","actualQuantity":"80","unit":"KGS","unitRateFc":"87.5","totalValueFC":"7028.7","currency":"USD","unitRateINR":"7485.6","date":"10-May-2025","totalValueINR":"598850","totalValueInUsd":"7028.7","indian_port":"Bombay Air","hs_no":"29362910","bill_no":"9987640","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"8138 DAYE ROAD, FENGCHENG TOWN FENGXIAN DISTRICT, SHANGHAI, CHINA","customerAddress":"EI-362-363-364 SITAPURA INDL. AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746815400,"product":"QUATREFOLIC (6S)5METHYLTETRAHYDROFOLIC ACID, GLUCOSAMINE SALT(BATCH NO:CM24001847,CM25000292)QUATREFOLIC (6S)5METHYLTETRAHYDROFOLIC ACID, GLUCOSAMINE SAL","address":"OLD NO.24 NEW NO.5,1ST MAIN ROAD,","city":"CHENNAI , TAMIL NADU.","supplier":"GENCOR PACIFIC LTD","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"GENCOR PACIFIC ORGANICS INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"8652.6","totalValueFC":"43440.4","currency":"USD","unitRateINR":"740229.9","date":"10-May-2025","totalValueINR":"3701149.65","totalValueInUsd":"43440.4","indian_port":"Madras Air","hs_no":"29362990","bill_no":"9989646","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"301 KAM ON BUILDING 176-A,QUEENS RO AD CENTRAL , , HONG KONG SDNF HONG KONG","customerAddress":"OLD NO.24 NEW NO.5,1ST MAIN ROAD,"},{"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":"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":1767897000,"product":"FOLIC ACID (NOT FOR MEDICAL USE) FOLIC ACID (NOT FOR MEDICAL USE)","address":"25D, Basant Vihar,","city":"Agra","supplier":"ZHEJIANG HUILI PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"RADHASHOK PHARMACHEM PRIVATE LTD","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"31","totalValueFC":"62043.8","currency":"USD","unitRateINR":"2814.8","date":"09-Jan-2026","totalValueINR":"5629600","totalValueInUsd":"62043.8","indian_port":"Delhi PPG ICD","hs_no":"29419090","bill_no":"61","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"ROOM 2403-A BOEE B NO. 836 MINHE RO AD XIAOSHAN DISTRICT HANGZHOU ZHEJI ANG - 310052, , China China","customerAddress":"25D, Basant Vihar,"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1770661800,"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":"29.8","totalValueFC":"29940.5","currency":"USD","unitRateINR":"2717.7","date":"10-Feb-2026","totalValueINR":"2717662.5","totalValueInUsd":"29940.5","indian_port":"Surat-EPZ\/SEZ","hs_no":"29362910","bill_no":"8061","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"Room 602,One Culture Plaza No.1349 LiYuan North Road, Ningbo SDNF China","customerAddress":"A\/403,ANJANI COMPLEX"}]
02-Jan-2022
28-Feb-2026
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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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

Aspol Manufacturers

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

Aspol Suppliers

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

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

Aspol USDMF

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

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

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

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

Aspol CEP

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

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

Aspol WC

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

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

Aspol 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 Aspol as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Aspol GMP

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

Aspol CoA

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

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

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