Find Folic Acid manufacturers, exporters & distributors on PharmaCompass

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FDF DossiersDRUG PRODUCT COMPOSITIONS

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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

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, 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.

API | Excipient name

Folic Acid

Folcidin Manufacturers

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

Folcidin Suppliers

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

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

Folcidin USDMF

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

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

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

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

Folcidin CEP

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

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

Folcidin WC

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

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

Folcidin 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 Folcidin as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Folcidin GMP

Folcidin 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 Folcidin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Folcidin GMP manufacturer or Folcidin GMP API supplier for your needs.

Folcidin CoA

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

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

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