Synopsis
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KDMF
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| Molecular Weight | 441.4 g/mol |
|---|---|
| Molecular Formula | C19H19N7O6 |
| XLogP3 | -1.1 |
| Hydrogen Bond Donor Count | 6 |
| Hydrogen Bond Acceptor Count | 9 |
| Rotatable Bond Count | 9 |
| Exact Mass | 441.13968135 g/mol |
| Monoisotopic Mass | 441.13968135 g/mol |
| Topological Polar Surface Area | 209 Ų |
| Heavy Atom Count | 32 |
| Formal Charge | 0 |
| Complexity | 767 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 2 | |
|---|---|
| Drug Name | Folic acid |
| PubMed Health | Folic Acid |
| Drug Classes | Nutriceutical, Nutritive Agent |
| Drug Label | Folic 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 Ingredient | Folic acid |
| Dosage Form | Tablet; Injectable |
| Route | Injection; Oral |
| Strength | 1 mg; 1mg; 5mg/ml |
| Market Status | Prescription |
| Company | Bicon Pharm; Excellium; Jubilant Cadista; Cadila Pharms; Invagen Pharms; Hikma Pharms; Watson Labs; Amneal Pharm; Fresenius Kabi Usa; Vintage; Contract Pharmacal |
| 2 of 2 | |
|---|---|
| Drug Name | Folic acid |
| PubMed Health | Folic Acid |
| Drug Classes | Nutriceutical, Nutritive Agent |
| Drug Label | Folic 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 Ingredient | Folic acid |
| Dosage Form | Tablet; Injectable |
| Route | Injection; Oral |
| Strength | 1 mg; 1mg; 5mg/ml |
| Market Status | Prescription |
| Company | Bicon Pharm; Excellium; Jubilant Cadista; Cadila Pharms; Invagen Pharms; Hikma Pharms; Watson Labs; Amneal Pharm; Fresenius Kabi Usa; Vintage; Contract Pharmacal |
API SUPPLIERS
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USDMF
GDUFA
DMF Review : Complete
Rev. Date : 2019-10-01
Pay. Date : 2019-06-03
DMF Number : 32976
Submission : 2018-10-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17004
Submission : 2003-12-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3870
Submission : 1980-07-14
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-14
Pay. Date : 2017-01-10
DMF Number : 30651
Submission : 2016-07-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-19
Pay. Date : 2014-12-16
DMF Number : 17600
Submission : 2004-08-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2318
Submission : 1974-08-23
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39653
Submission : 2024-03-06
Status : Active
Type : II
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4898
Submission : 1983-04-02
Status : Inactive
Type : II
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Certificate Number : R1-CEP 2005-031 - Rev 01
Status : Valid
Issue Date : 2021-02-15
Type : Chemical
Substance Number : 67
Certificate Number : R1-CEP 1996-045 - Rev 06
Status : Valid
Issue Date : 2023-08-10
Type : Chemical
Substance Number : 67
Certificate Number : CEP 1997-076 - Rev 12
Status : Valid
Issue Date : 2024-03-05
Type : Chemical
Substance Number : 67
Certificate Number : CEP 2023-161 - Rev 00
Status : Valid
Issue Date : 2024-11-13
Type : Chemical
Substance Number : 67
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Registration Number : 218MF10102
Registrant's Address : Wurmisweg 576, CH-4303, Kaiseraugst, Switzerland
Initial Date of Registration : 2006-01-30
Latest Date of Registration : 2006-07-20
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Date of Issue : 2019-07-29
Valid Till : 2022-06-28
Written Confirmation Number : WC-0033
Address of the Firm : Unit-III, Survey No. 57, Golkonda Kalan, Raikunta (V), Shamshabad (M), R.R. Dist...
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NDC Package Code : 81919-002
Start Marketing Date : 2021-09-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 63238-3400
Start Marketing Date : 2017-12-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 66326-505
Start Marketing Date : 2019-12-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 84824-001
Start Marketing Date : 2024-10-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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NDC Package Code : 84824-001
Start Marketing Date : 2024-10-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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NDC Package Code : 84824-001
Start Marketing Date : 2024-10-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Portfolio PDF
Product Web Link
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NDC Package Code : 84824-001
Start Marketing Date : 2024-10-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Basic Nutrition, your expert for sourcing from China, India and Europe.
About the Company : As an ISO9001, ISO22000 certificated supplier, Basic Nutrition supply high-quality ingredients for nutraceuticals. We can offer a range of products from small to large quantites: h...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 40 years of experience in Formulation development, manufacturing and commercialization. It offers a w...
About the Company : The company is in the business of manufacturing and marketing botanical extracts and nutraceuticals formulations to both domestic and global customers. The products include health/...
About the Company : We can help your company solve the payment problems during the trading from chinese factories. We supply you with OEM from china.We are professsionals with the competitive price an...
About the Company : Public health is always an imperative that implies immense responsibility, not a mere re-adjustable option. As a company operating under world’s second largest industry of Pharma...
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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
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
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
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
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
83
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.
A Folic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Folic Acid, including repackagers and relabelers. The FDA regulates Folic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Folic Acid 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 Folic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Folic Acid supplier is an individual or a company that provides Folic Acid active pharmaceutical ingredient (API) or Folic Acid finished formulations upon request. The Folic Acid suppliers may include Folic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Folic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Folic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Folic Acid active pharmaceutical ingredient (API) in detail. Different forms of Folic Acid DMFs exist exist since differing nations have different regulations, such as Folic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Folic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Folic Acid USDMF includes data on Folic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Folic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Folic Acid suppliers with USDMF on PharmaCompass.
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 Folic Acid Drug Master File in Japan (Folic Acid JDMF) empowers Folic Acid 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 Folic Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Folic Acid 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 Folic Acid suppliers with JDMF on PharmaCompass.
A Folic Acid CEP of the European Pharmacopoeia monograph is often referred to as a Folic Acid Certificate of Suitability (COS). The purpose of a Folic Acid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Folic Acid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Folic Acid to their clients by showing that a Folic Acid CEP has been issued for it. The manufacturer submits a Folic Acid CEP (COS) as part of the market authorization procedure, and it takes on the role of a Folic Acid CEP holder for the record. Additionally, the data presented in the Folic Acid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Folic Acid DMF.
A Folic Acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Folic Acid 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 Folic Acid suppliers with CEP (COS) on PharmaCompass.
A Folic Acid written confirmation (Folic Acid WC) is an official document issued by a regulatory agency to a Folic Acid manufacturer, verifying that the manufacturing facility of a Folic Acid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Folic Acid APIs or Folic Acid finished pharmaceutical products to another nation, regulatory agencies frequently require a Folic Acid WC (written confirmation) as part of the regulatory process.
click here to find a list of Folic Acid suppliers with Written Confirmation (WC) on PharmaCompass.
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 Folic Acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Folic Acid API and other APIs are published in this directory by the FDA.
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 Folic Acid 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.
The NDC directory also contains data on finished compounded human drug products that contain Folic Acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Folic Acid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Folic Acid suppliers with NDC on PharmaCompass.
Folic Acid 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 Folic Acid 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 Folic Acid GMP manufacturer or Folic Acid GMP API supplier for your needs.
A Folic Acid CoA (Certificate of Analysis) is a formal document that attests to Folic Acid's compliance with Folic Acid specifications and serves as a tool for batch-level quality control.
Folic Acid CoA mostly includes findings from lab analyses of a specific batch. For each Folic Acid 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.
Folic Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (Folic Acid EP), Folic Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Folic Acid USP).
