Synopsis
Synopsis
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KDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
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Stock Recap #PipelineProspector
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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
Basic Nutrition, your expert for sourcing from China, India and Europe.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17004
Submission : 2003-12-08
Status : Active
Type : II
Certificate Number : R1-CEP 2005-031 - Rev 01
Issue Date : 2021-02-15
Type : Chemical
Substance Number : 67
Status : Valid
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
GDUFA
DMF Review : Reviewed
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 : 2318
Submission : 1974-08-23
Status : Inactive
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4898
Submission : 1983-04-02
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
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| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Drugs in Development
Details:
Inofolic is a natural health product, combining myo-inositol and folic acid in a unique soft-gel capsule for women living with PCOS. Inofolic® helped 70% of women with PCOSii to regulate their menstrual cycles throughout the 16-week study period.
Lead Product(s): Inositol,Folic Acid
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Inofolic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 08, 2023
Lead Product(s) : Inositol,Folic Acid
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
BioSyent Launches Inofolic® for Women with Polycystic Ovary Syndrome (PCOS)
Details : Inofolic is a natural health product, combining myo-inositol and folic acid in a unique soft-gel capsule for women living with PCOS. Inofolic® helped 70% of women with PCOSii to regulate their menstrual cycles throughout the 16-week study period.
Product Name : Inofolic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 08, 2023
Details:
Cipla has acquired the four brands namely CPink, CDense, Productiv and Folinine to further strengthen its presence in the women's health segment, Cipla said in a filing to the BSE.
Lead Product(s): Folic Acid,Iron
Therapeutic Area: Hematology Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Vitamins/Minerals/Inorganic Salts
Sponsor: Cipla
Deal Size: $12.3 million Upfront Cash: Undisclosed
Deal Type: Acquisition July 02, 2020
Lead Product(s) : Folic Acid,Iron
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Cipla
Deal Size : $12.3 million
Deal Type : Acquisition
Cipla acquires 4 key brands from Wanbury for up to Rs 89 crore.
Details : Cipla has acquired the four brands namely CPink, CDense, Productiv and Folinine to further strengthen its presence in the women's health segment, Cipla said in a filing to the BSE.
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Undisclosed
July 02, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
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Regulatory Info :
Registration Country : Switzerland
Ferrum(II) ionisatum; Acidum folicum; Acidum ascorbicum (Vitamin C; E300)
Brand Name : Duofer Fol
Dosage Form : Filmtabl
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Italy
Brand Name : FERTIFOL
Dosage Form : Tablets
Dosage Strength : 400mcg
Packaging : 120 UNITS 400 MCG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : FOLIC ACID EG
Dosage Form : Tablets
Dosage Strength : 5 mg
Packaging : 60 UNITS 5 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Riboflavin; Disodium Hydrogen Phosphate; Niacinamide; Pyridoxine Hydrochloride; Pantothenic Acid; Ascorbic Acid; Biotin; Folic Acid; Vitamin B 12
Brand Name : Soluvit
Dosage Form : Thiamin Riboflav+.+Sodium Phosph.+Nicotinam.+Piridoss.+Ac.Pantoten.+Ac.Ascorb.+Biotin+Ac.Folic Cianocobal+.10Ml 10 Units
Dosage Strength : "AD" 10 VIALS EV 10 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Portugal
Thiamine; Riboflavin; Niacin; Pantothenic Acid; Pyridoxine; Vitamin B 12; Biotin; Folic Acid
Brand Name :
Dosage Form : Liquid Solution
Dosage Strength :
Packaging : 1 Bottle- 100 ML
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Portugal
Regulatory Info :
Registration Country : Portugal
Iron; Thiamine; Riboflavin; Niacin; Pyridoxine; Vitamin B 12; Folic Acid
Brand Name :
Dosage Form : Liquid Solution
Dosage Strength :
Packaging : 1 Bottle- 200 ML
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Portugal
Regulatory Info :
Registration Country : Sweden
Brand Name : folacin
Dosage Form : TABLET
Dosage Strength : 5 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Switzerland
Ferrum(II) ionisatum; Acidum folicum
Brand Name : Gyno-Tardyferon
Dosage Form : Ret Tabl
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Italy
Brand Name : FOLINA
Dosage Form : Soft Capsules
Dosage Strength : 5 mg
Packaging : 120 UNITS 5 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Generic
Registration Country : Turkey
Brand Name : Pregniofol
Dosage Form : TABLET
Dosage Strength :
Packaging : 90 Tablets
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : Turkey
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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 Vitamin B11 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vitamin B11, including repackagers and relabelers. The FDA regulates Vitamin B11 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vitamin B11 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 Vitamin B11 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vitamin B11 supplier is an individual or a company that provides Vitamin B11 active pharmaceutical ingredient (API) or Vitamin B11 finished formulations upon request. The Vitamin B11 suppliers may include Vitamin B11 API manufacturers, exporters, distributors and traders.
click here to find a list of Vitamin B11 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vitamin B11 DMF (Drug Master File) is a document detailing the whole manufacturing process of Vitamin B11 active pharmaceutical ingredient (API) in detail. Different forms of Vitamin B11 DMFs exist exist since differing nations have different regulations, such as Vitamin B11 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vitamin B11 DMF submitted to regulatory agencies in the US is known as a USDMF. Vitamin B11 USDMF includes data on Vitamin B11's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vitamin B11 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vitamin B11 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 Vitamin B11 Drug Master File in Japan (Vitamin B11 JDMF) empowers Vitamin B11 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 Vitamin B11 JDMF during the approval evaluation for pharmaceutical products. At the time of Vitamin B11 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 Vitamin B11 suppliers with JDMF on PharmaCompass.
A Vitamin B11 CEP of the European Pharmacopoeia monograph is often referred to as a Vitamin B11 Certificate of Suitability (COS). The purpose of a Vitamin B11 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Vitamin B11 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Vitamin B11 to their clients by showing that a Vitamin B11 CEP has been issued for it. The manufacturer submits a Vitamin B11 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Vitamin B11 CEP holder for the record. Additionally, the data presented in the Vitamin B11 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Vitamin B11 DMF.
A Vitamin B11 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Vitamin B11 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 Vitamin B11 suppliers with CEP (COS) on PharmaCompass.
A Vitamin B11 written confirmation (Vitamin B11 WC) is an official document issued by a regulatory agency to a Vitamin B11 manufacturer, verifying that the manufacturing facility of a Vitamin B11 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vitamin B11 APIs or Vitamin B11 finished pharmaceutical products to another nation, regulatory agencies frequently require a Vitamin B11 WC (written confirmation) as part of the regulatory process.
click here to find a list of Vitamin B11 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 Vitamin B11 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vitamin B11 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 Vitamin B11 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 Vitamin B11 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vitamin B11 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vitamin B11 suppliers with NDC on PharmaCompass.
Vitamin B11 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 Vitamin B11 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 Vitamin B11 GMP manufacturer or Vitamin B11 GMP API supplier for your needs.
A Vitamin B11 CoA (Certificate of Analysis) is a formal document that attests to Vitamin B11's compliance with Vitamin B11 specifications and serves as a tool for batch-level quality control.
Vitamin B11 CoA mostly includes findings from lab analyses of a specific batch. For each Vitamin B11 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.
Vitamin B11 may be tested according to a variety of international standards, such as European Pharmacopoeia (Vitamin B11 EP), Vitamin B11 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vitamin B11 USP).
