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CEP/COS
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JDMF
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KDMF
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USP
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JP
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Europe
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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 |
Panvo Organics: Advancing quality APIs and formulations with Halal, Kosher, US FDA, and WHO-approved manufacturing excellence.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm :
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25789
Submission : 2013-03-01
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2022-02-17
Pay. Date : 2021-12-14
DMF Number : 36528
Submission : 2021-12-20
Status : Active
Type : II
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 PRESCRIPTION COMPOUNDING

GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-24
Pay. Date : 2013-04-03
DMF Number : 26531
Submission : 2013-03-12
Status : Active
Type : II


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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 : 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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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 : 69723-002
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 : 51927-5180
Start Marketing Date : 2022-05-13
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...

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Panvo Organics: Advancing quality APIs and formulations with Halal, Kosher, US FDA, and WHO-approved manufacturing excellence.
About the Company : Panvo Organics Pvt. Ltd., established in 2006, is a WHO-GMP certified manufacturer of Active Pharmaceutical Ingredients, novel formulations, and sustainable agriculture inputs. The...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Nuray Chemicals Pvt Ltd, established in 2012 near Chennai, is an API manufacturer for highly regulated markets. Its state-of-the-art R&D facility specializes in synthesizing NCEs, ...
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
About the Company : Zeon Pharma Industries India Pvt. Ltd. is an ISO 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), phytochemicals, herba...
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
L-5-Methyl Tetrahydrofolate Calcium
About the Company : Macsen is a USFDA-registered, TGA GMP and WHO-GMP certified manufacturer and supplier of Active Pharmaceutical Ingredients (APIs), Biological Stains, and Specialty Fine Chemicals. ...
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
L5-Methyltetrahydrofolate Calcium
About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...
L-5-Methyltetrahydrofolate Calcium
About the Company : Allastir instituted the services in 2010 with a motive to cater the pharmaceutical industry with niche API's. In Allastir we strongly believe in team work and customer satisfaction...

About the Company : Anthem Biosciences is a leading contract research and innovation service provider (CRISP) in Bengaluru, India, which manufactures novel drug actives. Established in 2007, it specia...

About the Company : Anthem Biosciences is a leading contract research and innovation service provider (CRISP) in Bengaluru, India, which manufactures novel drug actives. Established in 2007, it specia...

About the Company : The company is in the business of manufacturing and marketing botanical extracts and nutraceuticals formulations to both domestic and global customers. The products include health/...

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Dosage Form : Emulsion
Grade : Parenteral
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Grade : Parenteral
Application : Parenteral
Excipient Details : Soybean oil is used as a solvent for common and complex injections.
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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 L-methylfolate-calcium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of L-methylfolate-calcium, including repackagers and relabelers. The FDA regulates L-methylfolate-calcium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. L-methylfolate-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 L-methylfolate-calcium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A L-methylfolate-calcium supplier is an individual or a company that provides L-methylfolate-calcium active pharmaceutical ingredient (API) or L-methylfolate-calcium finished formulations upon request. The L-methylfolate-calcium suppliers may include L-methylfolate-calcium API manufacturers, exporters, distributors and traders.
click here to find a list of L-methylfolate-calcium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A L-methylfolate-calcium DMF (Drug Master File) is a document detailing the whole manufacturing process of L-methylfolate-calcium active pharmaceutical ingredient (API) in detail. Different forms of L-methylfolate-calcium DMFs exist exist since differing nations have different regulations, such as L-methylfolate-calcium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A L-methylfolate-calcium DMF submitted to regulatory agencies in the US is known as a USDMF. L-methylfolate-calcium USDMF includes data on L-methylfolate-calcium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The L-methylfolate-calcium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of L-methylfolate-calcium suppliers with USDMF on PharmaCompass.
A L-methylfolate-calcium written confirmation (L-methylfolate-calcium WC) is an official document issued by a regulatory agency to a L-methylfolate-calcium manufacturer, verifying that the manufacturing facility of a L-methylfolate-calcium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting L-methylfolate-calcium APIs or L-methylfolate-calcium finished pharmaceutical products to another nation, regulatory agencies frequently require a L-methylfolate-calcium WC (written confirmation) as part of the regulatory process.
click here to find a list of L-methylfolate-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 L-methylfolate-calcium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for L-methylfolate-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 L-methylfolate-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 L-methylfolate-calcium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a L-methylfolate-calcium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of L-methylfolate-calcium suppliers with NDC on PharmaCompass.
L-methylfolate-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 L-methylfolate-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 L-methylfolate-calcium GMP manufacturer or L-methylfolate-calcium GMP API supplier for your needs.
A L-methylfolate-calcium CoA (Certificate of Analysis) is a formal document that attests to L-methylfolate-calcium's compliance with L-methylfolate-calcium specifications and serves as a tool for batch-level quality control.
L-methylfolate-calcium CoA mostly includes findings from lab analyses of a specific batch. For each L-methylfolate-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.
L-methylfolate-calcium may be tested according to a variety of international standards, such as European Pharmacopoeia (L-methylfolate-calcium EP), L-methylfolate-calcium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (L-methylfolate-calcium USP).