Synopsis
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DRUG PRODUCT COMPOSITIONS0
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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.
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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
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 2318
Submission : 1974-08-23
Status : Inactive
Type : II
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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
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
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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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API Imports and Exports
| 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: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 08, 2023
Lead Product(s) : Inositol,Folic Acid
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Inofolic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
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: ApprovedProduct Type: Small molecule
Sponsor: Cipla
Deal Size: $12.3 million Upfront Cash: Undisclosed
Deal Type: Acquisition February 07, 2020
Lead Product(s) : Folic Acid,Iron
Therapeutic Area : Hematology
Highest Development Status : Approved
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.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
February 07, 2020
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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Autrin Capsules
Dosage Form : CAP
Dosage Strength : 2mg
Packaging : 30X1µg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Filibon
Dosage Form : CAP
Dosage Strength : 1u
Packaging : 30X1u
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.
Regulatory Info : DISCN
Registration Country : USA
Brand Name : FOLICET
Dosage Form : TABLET;ORAL
Dosage Strength : 1MG
Packaging :
Approval Date : 1982-01-01
Application Number : 87438
Regulatory Info : DISCN
Registration Country : USA
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Iron III Hydroxide Polymaltose Complex; Folic Acid; Zinc
Brand Name :
Dosage Form : Chewable Tablet
Dosage Strength : 100MG; 0.350MG; 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Iron III Hydroxide Polymaltose Complex; Folic Acid
Brand Name :
Dosage Form : Chewable Tablet
Dosage Strength : 100MG; 0.350MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info : DMF Available|FDF Compliance-BP, USP
Registration Country : India
Brand Name :
Dosage Form : DC Granules
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : DMF Available|FDF Compliance-BP, USP
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info : DMF Available|FDF Compliance-BP, USP
Registration Country : India
Brand Name :
Dosage Form : DC Granules
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : DMF Available|FDF Compliance-BP, USP
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info : DMF Available|FDF Compliance-IH
Registration Country : India
Iron III Hydroxide Polymaltose Complex; Folic Acid
Brand Name :
Dosage Form : DC Granules
Dosage Strength : 100MG; 0.350MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : DMF Available|FDF Compliance-IH
Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Topical Massage Oil
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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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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