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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 | |
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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 | |
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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 |
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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.
A FOL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of FOL, including repackagers and relabelers. The FDA regulates FOL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. FOL 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 FOL manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A FOL supplier is an individual or a company that provides FOL active pharmaceutical ingredient (API) or FOL finished formulations upon request. The FOL suppliers may include FOL API manufacturers, exporters, distributors and traders.
click here to find a list of FOL suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A FOL DMF (Drug Master File) is a document detailing the whole manufacturing process of FOL active pharmaceutical ingredient (API) in detail. Different forms of FOL DMFs exist exist since differing nations have different regulations, such as FOL USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A FOL DMF submitted to regulatory agencies in the US is known as a USDMF. FOL USDMF includes data on FOL's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The FOL USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of FOL 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 FOL Drug Master File in Japan (FOL JDMF) empowers FOL 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 FOL JDMF during the approval evaluation for pharmaceutical products. At the time of FOL 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 FOL suppliers with JDMF on PharmaCompass.
A FOL CEP of the European Pharmacopoeia monograph is often referred to as a FOL Certificate of Suitability (COS). The purpose of a FOL CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of FOL EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of FOL to their clients by showing that a FOL CEP has been issued for it. The manufacturer submits a FOL CEP (COS) as part of the market authorization procedure, and it takes on the role of a FOL CEP holder for the record. Additionally, the data presented in the FOL CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the FOL DMF.
A FOL CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. FOL 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 FOL suppliers with CEP (COS) on PharmaCompass.
A FOL written confirmation (FOL WC) is an official document issued by a regulatory agency to a FOL manufacturer, verifying that the manufacturing facility of a FOL active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting FOL APIs or FOL finished pharmaceutical products to another nation, regulatory agencies frequently require a FOL WC (written confirmation) as part of the regulatory process.
click here to find a list of FOL 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 FOL as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for FOL 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 FOL 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 FOL and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a FOL NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of FOL suppliers with NDC on PharmaCompass.
FOL 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 FOL 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 FOL GMP manufacturer or FOL GMP API supplier for your needs.
A FOL CoA (Certificate of Analysis) is a formal document that attests to FOL's compliance with FOL specifications and serves as a tool for batch-level quality control.
FOL CoA mostly includes findings from lab analyses of a specific batch. For each FOL 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.
FOL may be tested according to a variety of international standards, such as European Pharmacopoeia (FOL EP), FOL JP (Japanese Pharmacopeia) and the US Pharmacopoeia (FOL USP).