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EDQM
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USP
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JP
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Others
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Europe
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DRUG PRODUCT COMPOSITIONS
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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 : 2022-06-06
Valid Till : 2025-06-05
Written Confirmation Number : WC-0523
Address of the Firm : Unit-II, No. 276-P & 277-P, Sy no.20, Bannikuppe Road, Harohalli Industrial area...
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
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Global Sales Information
Company : Bayer,Pharm Div
Drospir/Eth Estra/Levomefol Ca
Drug Cost (USD) : 31,516
Year : 2023
Prescribers : 14
Prescriptions : 48
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Lupin Pharmaceu
Drospir/Eth Estra/Levomefol Ca
Drug Cost (USD) : 20,877
Year : 2023
Prescribers : 40
Prescriptions : 109
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Sandoz
Drospir/Eth Estra/Levomefol Ca
Drug Cost (USD) : 32,098
Year : 2023
Prescribers : 43
Prescriptions : 149
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Aventura Pharma
Levomefolate Calcium
Drug Cost (USD) : 579
Year : 2023
Prescribers :
Prescriptions : 12
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Bayer,Pharm Div
Drospir/Eth Estra/Levomefol Ca
Drug Cost (USD) : 7,555
Year : 2023
Prescribers :
Prescriptions : 19
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Lupin Pharmaceu
Drospir/Eth Estra/Levomefol Ca
Drug Cost (USD) : 6,158
Year : 2023
Prescribers : 12
Prescriptions : 44
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Aventura Pharma
Levomefolate Calcium
Drug Cost (USD) : 478
Year : 2022
Prescribers :
Prescriptions : 12
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Bayer,Pharm Div
Drospir/Eth Estra/Levomefol Ca
Drug Cost (USD) : 40,307
Year : 2022
Prescribers : 21
Prescriptions : 69
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Lupin Pharmaceu
Drospir/Eth Estra/Levomefol Ca
Drug Cost (USD) : 18,581
Year : 2022
Prescribers : 30
Prescriptions : 85
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Lupin Pharmaceu
Drospir/Eth Estra/Levomefol Ca
Drug Cost (USD) : 6,321
Year : 2022
Prescribers :
Prescriptions : 22
Portfolio PDF
Product Web Link
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Market Place
Reply
29 Apr 2024
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17 Feb 2022
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22 Mar 2021
Patents & EXCLUSIVITIES
Patent Expiration Date : 2030-07-17
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
US Patent Number : 11617751
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 22532
Patent Use Code : U-3574
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2030-07-17
Patent Expiration Date : 2030-02-08
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
US Patent Number : 8617597
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 22574
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2030-02-08
Patent Expiration Date : 2030-02-08
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
US Patent Number : 8617597
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 22532
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2030-02-08
Patent Expiration Date : 2030-07-17
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
US Patent Number : 11617751
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 22574
Patent Use Code : U-1
Delist Requested :
Patent Use Description : PREVENTION OF PREGNANC...
Patent Expiration Date : 2030-07-17
Patent Expiration Date : 2030-07-17
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
US Patent Number : 11617751
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 22574
Patent Use Code : U-3572
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2030-07-17
Patent Expiration Date : 2030-07-17
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
US Patent Number : 11617751
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 22532
Patent Use Code : U-1
Delist Requested :
Patent Use Description : PREVENTION OF PREGNANC...
Patent Expiration Date : 2030-07-17
Patent Expiration Date : 2030-07-17
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
US Patent Number : 11617751
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 22532
Patent Use Code : U-3572
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2030-07-17
Patent Expiration Date : 2030-07-17
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
US Patent Number : 11617751
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 22532
Patent Use Code : U-3573
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2030-07-17
ABOUT THIS PAGE
55
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 Deplin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Deplin, including repackagers and relabelers. The FDA regulates Deplin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Deplin 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 Deplin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Deplin supplier is an individual or a company that provides Deplin active pharmaceutical ingredient (API) or Deplin finished formulations upon request. The Deplin suppliers may include Deplin API manufacturers, exporters, distributors and traders.
click here to find a list of Deplin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Deplin DMF (Drug Master File) is a document detailing the whole manufacturing process of Deplin active pharmaceutical ingredient (API) in detail. Different forms of Deplin DMFs exist exist since differing nations have different regulations, such as Deplin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Deplin DMF submitted to regulatory agencies in the US is known as a USDMF. Deplin USDMF includes data on Deplin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Deplin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Deplin suppliers with USDMF on PharmaCompass.
A Deplin written confirmation (Deplin WC) is an official document issued by a regulatory agency to a Deplin manufacturer, verifying that the manufacturing facility of a Deplin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Deplin APIs or Deplin finished pharmaceutical products to another nation, regulatory agencies frequently require a Deplin WC (written confirmation) as part of the regulatory process.
click here to find a list of Deplin 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 Deplin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Deplin 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 Deplin 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 Deplin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Deplin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Deplin suppliers with NDC on PharmaCompass.
Deplin 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 Deplin 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 Deplin GMP manufacturer or Deplin GMP API supplier for your needs.
A Deplin CoA (Certificate of Analysis) is a formal document that attests to Deplin's compliance with Deplin specifications and serves as a tool for batch-level quality control.
Deplin CoA mostly includes findings from lab analyses of a specific batch. For each Deplin 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.
Deplin may be tested according to a variety of international standards, such as European Pharmacopoeia (Deplin EP), Deplin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Deplin USP).