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1. Metafolin
2. N-(4-(((2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl)methyl)amino)benzoyl)-l-glutamic Acid Calcium Salt
3. Safyral
1. 151533-22-1
2. Calcium Levomefolate
3. Bodyfolin
4. Metafolin
5. Nutrifolin
6. Levomefolinate Calcium
7. Lmca
8. L-methylfolate Calcium
9. Extrafolate-s
10. Levomefolate (calcium)
11. Deplin
12. Levomefolate Calcium [usan]
13. L-5-mthf-ca
14. L-methylfolate-calcium
15. Calcium L-5-methyltetrahydrofolate
16. Lmc-a
17. L-5-methyl Tetrahydrofolic
18. Bay86-7660
19. Bay 86-7660
20. L-5-methyltetrahydrofolate Calcium
21. A9r10k3f2f
22. (s)-2-(4-((((s)-2-amino-5-methyl-4-oxo-3,4,5,6,7,8-hexahydropteridin-6-yl)methyl)amino)benzamido)pentanedioic Acid, Calcium Salt
23. Metafolin (tn)
24. (6s)-5-methyltetrahydrofolic Acid Calcium Salt
25. Levomefolate Calcium (usan)
26. Calcium;(2s)-2-[[4-[[(6s)-2-amino-5-methyl-4-oxo-3,6,7,8-tetrahydropteridin-6-yl]methylamino]benzoyl]amino]pentanedioate
27. L-5-methyletrahydrofolate Calcium
28. Calcium N-(4-((((6s)-2-amino-5-methyl-4-oxo-1,4,5,6,7,8-hexahydropteridin-6-yl)methyl)amino)benzoyl)-l-glutamate
29. Unii-a9r10k3f2f
30. Calcium L-methylfolate
31. Ndi 638 [fdms]
32. Chembl1615371
33. Ndi 638
34. Chebi:189695
35. Calcium;(2s)-2-[[4-[[(6s)-2-amino-5-methyl-4-oxo-1,6,7,8-tetrahydropteridin-6-yl]methylamino]benzoyl]amino]pentanedioate
36. Levomefolate Calcium [vandf]
37. Calcium Levomefolate [mart.]
38. Mfcd18642975
39. Calcium Levomefolate [who-dd]
40. Akos025117256
41. Akos025402270
42. Ac-7457
43. Cs-1066
44. Gs-6017
45. Hy-17383
46. Levomefolate Calcium [orange Book]
47. N-(4-(((2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl)methyl)amino)benzoyl)-l-glutamic Acid Calcium Salt
48. Beyaz Component Levomefolate Calcium
49. Safyral Component Levomefolate Calcium
50. Levomefolate Calcium Component Of Beyaz
51. D09354
52. Calcium L-5-methyltetrahydrofolate [dsc]
53. Levomefolate Calcium Component Of Safyral
54. L-5-methyltetrahydrofolic Acid, Calcium Salt
55. Q27273818
56. 6(s)-5-methyltetrahydrofolic Acid, Calcium Salt [ndi]
57. (s)-2-(4-((((s)-2-amino-5-methyl-4-oxo-3,4,5,6,7,8-hexahydropteridin-6-yl)methyl)amino)benzamido)pentanedioicacid,calciumsalt
58. 129025-21-4
59. Calcium (2s)-2-[4-({[(6s)-2-amino-5-methyl-4-oxo-3,4,5,6,7,8-hexahydropteridin-6-yl]methyl}amino)benzamido]pentanedioate
60. Calcium (2s)-2-{[4-({[(6s)-2-amino-5-methyl-4-oxo-3,4,5,6,7,8-hexahydropteridin-6-yl]methyl}amino)phenyl]formamido}pentanedioate
61. Calcium (4-((((s)-2-amino-5-methyl-4-oxo-3,4,5,6,7,8-hexahydropteridin-6-yl)methyl)amino)benzoyl)-l-glutamate
62. L-glutamic Acid, N-(4-((((6s)-2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl)methyl)amino)benzoyl)-, Calcium Salt (1:1)
1. Deplin
2. Prefolic A
3. L-methyl Folate
4. Methyl Folate
Molecular Weight | 497.5 g/mol |
---|---|
Molecular Formula | C20H23CaN7O6 |
Hydrogen Bond Donor Count | 5 |
Hydrogen Bond Acceptor Count | 10 |
Rotatable Bond Count | 7 |
Exact Mass | 497.1335723 g/mol |
Monoisotopic Mass | 497.1335723 g/mol |
Topological Polar Surface Area | 204 Ų |
Heavy Atom Count | 34 |
Formal Charge | 0 |
Complexity | 854 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
GDUFA
DMF Review : Complete
Rev. Date : 2022-02-17
Pay. Date : 2021-12-14
DMF Number : 36528
Submission : 2021-12-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-10-21
Pay. Date : 2016-08-31
DMF Number : 26016
Submission : 2012-04-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25789
Submission : 2013-03-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-24
Pay. Date : 2013-04-03
DMF Number : 26531
Submission : 2013-03-12
Status : Active
Type : II
Calcium L-5 MethylTetrahydrofolate USP
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0104
Address of the Firm : 125 & 126, Sipcot Industrial Complex, Hosur 635126, Tamil Nadu
Calcium L-5 Methyltetrahydrofolate USP
Date of Issue : 22-07-2025
Valid Till : 07-07-2028
Written Confirmation Number : WC--0104
Address of the Firm : 124, 125 and 126, SIPCOT Industrial Complex, Hosur -635126, Tamil Nadu, India
NDC Package Code : 43615-002
Start Marketing Date : 2015-05-31
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 76438-005
Start Marketing Date : 2021-12-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 54239-008
Start Marketing Date : 2012-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 80680-001
Start Marketing Date : 2020-09-21
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 69723-002
Start Marketing Date : 2015-05-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 51927-5180
Start Marketing Date : 2022-05-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
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Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
Undisclosed
Lead Product(s): Ethinyl Estradiol,Drospirenone,Levomefolate Calcium
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 18, 2013
Lead Product(s) : Ethinyl Estradiol,Drospirenone,Levomefolate Calcium
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 18, 2013
Details:
Undisclosed
Lead Product(s):
Omega-3 Fatty Acid,Full Spectrum Vitamin,Essential - Hydroxytyrosol,Maltodextrin Fiber Supplement,Mineral Boost (Magnesium),Nicotinamide,Methyl B12,Taurine,Creatine,Vitamin B1,Riboflavin,Acetylcysteine,Alpha Lipoic Acid,L Acetyl Carnitine,
Therapeutic Area: Neurology
Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Other Small Molecule Sponsor:
Direct MS Canada | DJO Incorporated | Pinnaclife Inc. | TZ Press, LLC
Deal Size: Inapplicable
Upfront Cash: Inapplicable
Deal Type: Inapplicable
June 27, 2011
Lead Product(s) :
Omega-3 Fatty Acid,Full Spectrum Vitamin,Essential - Hydroxytyrosol,Maltodextrin Fiber Supplement,Mineral Boost (Magnesium),Nicotinamide,Methyl B12,Taurine,Creatine,Vitamin B1,Riboflavin,Acetylcysteine,Alpha Lipoic Acid,L Acetyl Carnitine,
Therapeutic Area :
Neurology Highest Development Status :
Phase I Partner/Sponsor/Collaborator :
Direct MS Canada | DJO Incorporated | Pinnaclife Inc. | TZ Press, LLC Deal Size : Inapplicable Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
June 27, 2011
Details:
Undisclosed
Lead Product(s): Drospirenone,Ethinyl Estradiol,Levomefolate Calcium
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Hormone
Sponsor: Bayer AG
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 26, 2011
Lead Product(s) : Drospirenone,Ethinyl Estradiol,Levomefolate Calcium
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Bayer AG
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Hormone
Upfront Cash : Inapplicable
May 26, 2011
Regulatory Info : RX
Registration Country : USA
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
Brand Name : DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
Dosage Form : TABLET;ORAL
Dosage Strength : 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG
Packaging :
Approval Date : 2016-10-11
Application Number : 203593
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
Brand Name : DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
Dosage Form : TABLET;ORAL
Dosage Strength : 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG
Packaging :
Approval Date : 2016-10-11
Application Number : 203594
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form :
Dosage Strength : 1MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
Brand Name : SAFYRAL
Dosage Form : TABLET;ORAL
Dosage Strength : 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG
Packaging :
Approval Date : 2010-12-16
Application Number : 22574
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Canada
Brand Name : YAZ PLUS
Dosage Form : TABLET
Dosage Strength : 0.451MG
Packaging : 28
Approval Date :
Application Number : 2387433
Regulatory Info :
Registration Country : Canada
Regulatory Info : Originator
Registration Country : South Africa
Levomefolate Calcium (24 pink)
Brand Name : Yaz Plus
Dosage Form : FCT
Dosage Strength : 3mg
Packaging : 28X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Levomefolate Calcium (4 light orange)
Brand Name : Yaz Plus
Dosage Form : FCT
Dosage Strength : 3mg
Packaging : 28X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Levomefolate Calcium (7 light orange)
Brand Name : Yasmin Plus
Dosage Form : FCT
Dosage Strength : 3mg
Packaging : 28X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Oral Dispersible Film
Dosage Strength : 15MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
Brand Name : DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
Dosage Form : TABLET;ORAL
Dosage Strength : 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG
Packaging :
Approval Date : 2018-06-13
Application Number : 205947
Regulatory Info : RX
Registration Country : USA
RLD : No
TE Code : AB
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
Brand Name : DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
Dosage Form : TABLET;ORAL
Dosage Strength : 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG
Approval Date : 2016-10-11
Application Number : 203593
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
Brand Name : DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
Dosage Form : TABLET;ORAL
Dosage Strength : 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG
Approval Date : 2016-10-11
Application Number : 203594
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : Yes
TE Code : AB
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
Brand Name : BEYAZ
Dosage Form : TABLET;ORAL
Dosage Strength : 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG
Approval Date : 2010-09-24
Application Number : 22532
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : Yes
TE Code : AB
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
Brand Name : SAFYRAL
Dosage Form : TABLET;ORAL
Dosage Strength : 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG
Approval Date : 2010-12-16
Application Number : 22574
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AB
RLD : No
TE Code : AB
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
Brand Name : DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
Dosage Form : TABLET;ORAL
Dosage Strength : 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG
Approval Date : 2018-06-13
Application Number : 205947
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
RLD : No
TE Code : AB
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
Brand Name : TYDEMY
Dosage Form : TABLET;ORAL
Dosage Strength : 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG
Approval Date : 2017-12-12
Application Number : 205948
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
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PharmaCompass offers a list of Levomefolate Calcium 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 Levomefolate Calcium manufacturer or Levomefolate Calcium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Levomefolate Calcium manufacturer or Levomefolate Calcium supplier.
PharmaCompass also assists you with knowing the Levomefolate Calcium API Price utilized in the formulation of products. Levomefolate Calcium API Price is not always fixed or binding as the Levomefolate Calcium Price is obtained through a variety of data sources. The Levomefolate Calcium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Levomefolate Calcium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levomefolate Calcium, including repackagers and relabelers. The FDA regulates Levomefolate Calcium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levomefolate Calcium 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 Levomefolate Calcium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levomefolate Calcium supplier is an individual or a company that provides Levomefolate Calcium active pharmaceutical ingredient (API) or Levomefolate Calcium finished formulations upon request. The Levomefolate Calcium suppliers may include Levomefolate Calcium API manufacturers, exporters, distributors and traders.
click here to find a list of Levomefolate Calcium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Levomefolate Calcium DMF (Drug Master File) is a document detailing the whole manufacturing process of Levomefolate Calcium active pharmaceutical ingredient (API) in detail. Different forms of Levomefolate Calcium DMFs exist exist since differing nations have different regulations, such as Levomefolate Calcium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levomefolate Calcium DMF submitted to regulatory agencies in the US is known as a USDMF. Levomefolate Calcium USDMF includes data on Levomefolate Calcium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levomefolate Calcium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levomefolate Calcium suppliers with USDMF on PharmaCompass.
A Levomefolate Calcium written confirmation (Levomefolate Calcium WC) is an official document issued by a regulatory agency to a Levomefolate Calcium manufacturer, verifying that the manufacturing facility of a Levomefolate Calcium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Levomefolate Calcium APIs or Levomefolate Calcium finished pharmaceutical products to another nation, regulatory agencies frequently require a Levomefolate Calcium WC (written confirmation) as part of the regulatory process.
click here to find a list of Levomefolate Calcium 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 Levomefolate Calcium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Levomefolate Calcium 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 Levomefolate Calcium 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 Levomefolate Calcium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Levomefolate Calcium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Levomefolate Calcium suppliers with NDC on PharmaCompass.
Levomefolate Calcium 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 Levomefolate Calcium 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 Levomefolate Calcium GMP manufacturer or Levomefolate Calcium GMP API supplier for your needs.
A Levomefolate Calcium CoA (Certificate of Analysis) is a formal document that attests to Levomefolate Calcium's compliance with Levomefolate Calcium specifications and serves as a tool for batch-level quality control.
Levomefolate Calcium CoA mostly includes findings from lab analyses of a specific batch. For each Levomefolate Calcium 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.
Levomefolate Calcium may be tested according to a variety of international standards, such as European Pharmacopoeia (Levomefolate Calcium EP), Levomefolate Calcium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Levomefolate Calcium USP).