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1. 5 Formyltetrahydrofolate
2. 5 Formyltetrahydropteroylglutamate
3. 5-formyltetrahydrofolate
4. 5-formyltetrahydropteroylglutamate
5. Acid, Folinic
6. Calcium Folinate
7. Citrovorum Factor
8. Factor, Citrovorum
9. Folinate, Calcium
10. Folinic Acid
11. Folinic Acid Sf
12. Folinic Acid-sf
13. Leucovorin
14. Leucovorin, (d)-isomer
15. Leucovorin, (dl)-isomer
16. Leucovorin, (r)-isomer
17. Leucovorin, Calcium
18. Leucovorin, Calcium (1:1) Salt
19. Leucovorin, Calcium (1:1) Salt, (dl)-isomer
20. Leucovorin, Calcium (1:1) Salt, Pentahydrate
21. Leucovorin, Monosodium Salt
22. Leukovorin
23. Leukovorum
24. Monosodium Salt Leucovorin
25. N(5)-formyltetrahydrofolate
26. Wellcovorin
1. Calcium Folinate
2. Calcium Citrovorum Factor
3. Folinic Acid Calcium Salt
4. Folinic Acid-sf, Calcium Salt
5. (+)-l-folinic Acid, Calcium Salt
6. 1492-18-8
7. Nsc3590
8. Sr-05000001662
9. Pharmakon1600-01500364
10. Nsc757083
11. Nsc-757083
12. Sr-05000001662-1
13. Sr-05000001662-2
14. Glutamic Acid,6,7,8-tetrahydro-4-hydroxy-6- Pteridinyl)methyl]amino]benzoyl]-, Calcium Salt (1:1), L-
15. L-glutamic Acid,4,5,6,7,8-hexahydro-4-oxo-6- Pteridinyl)methyl]amino]benzoyl]-, Calcium Salt (1:1), (s)-
Molecular Weight | 513.5 g/mol |
---|---|
Molecular Formula | C20H23CaN7O7+2 |
Hydrogen Bond Donor Count | 7 |
Hydrogen Bond Acceptor Count | 10 |
Rotatable Bond Count | 9 |
Exact Mass | 513.1284869 g/mol |
Monoisotopic Mass | 513.1284869 g/mol |
Topological Polar Surface Area | 216 Ų |
Heavy Atom Count | 35 |
Formal Charge | 2 |
Complexity | 911 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 1 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
Antidotes
Agents counteracting or neutralizing the action of POISONS. (See all compounds classified as Antidotes.)
Vitamin B Complex
A group of water-soluble vitamins, some of which are COENZYMES. (See all compounds classified as Vitamin B Complex.)
V - Various
V03 - All other therapeutic products
V03A - All other therapeutic products
V03AF - Detoxifying agents for antineoplastic treatment
V03AF03 - Calcium folinate
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-10-18
Pay. Date : 2024-09-19
DMF Number : 40427
Submission : 2024-09-04
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-07-26
Pay. Date : 2024-06-10
DMF Number : 38878
Submission : 2023-09-27
Status : Active
Type : II
Certificate Number : R1-CEP 2011-370 - Rev 00
Issue Date : 2019-07-26
Type : Chemical
Substance Number : 978
Status : Valid
NDC Package Code : 63660-0012
Start Marketing Date : 2012-10-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-02
Pay. Date : 2018-02-20
DMF Number : 5261
Submission : 1984-01-23
Status : Active
Type : II
Certificate Number : R1-CEP 1996-055 - Rev 08
Issue Date : 2023-05-19
Type : Chemical
Substance Number : 978
Status : Valid
Registration Number : 218MF10352
Registrant's Address : Weisshausmatte CH-6460 Altdorf Switzerland
Initial Date of Registration : 2006-03-17
Latest Date of Registration : --
NDC Package Code : 54784-009
Start Marketing Date : 1984-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Wooshin Labotech Co., Ltd.
Registration Date : 2021-04-05
Registration Number : 20210405-210-J-686
Manufacturer Name : Merck & Cie KmG@Dottikon Exclusive Synthesis AG
Manufacturer Address : Im Laternenacker 5,CH-8200 Schaffhausen, Switzerland@Hembrunnstrasse 17 CH-5605 Dottikon Switzerland
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-08-16
Pay. Date : 2019-06-24
DMF Number : 33740
Submission : 2019-05-18
Status : Active
Type : II
NDC Package Code : 68034-100
Start Marketing Date : 2019-05-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-04
Pay. Date : 2013-09-25
DMF Number : 5046
Submission : 1983-06-30
Status : Active
Type : II
Certificate Number : CEP 1997-051 - Rev 10
Issue Date : 2024-03-06
Type : Chemical
Substance Number : 978
Status : Valid
Registration Number : 221MF10021
Registrant's Address : Via Figino 6,6917 Barbengo/Lugano, Switzerland
Initial Date of Registration : 2009-01-28
Latest Date of Registration : --
NDC Package Code : 54239-002
Start Marketing Date : 1983-06-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2022-01-05
Registration Number : 20220105-210-J-1193
Manufacturer Name : Cerbios pharma SA
Manufacturer Address : Via Figino 6, 6917 Barbengo/Lugano, Switzerland
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25334
Submission : 2011-08-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16718
Submission : 2003-07-18
Status : Inactive
Type : II
Certificate Number : CEP 2004-009 - Rev 04
Issue Date : 2024-04-15
Type : Chemical
Substance Number : 978
Status : Valid
Registration Number : 227MF10147
Registrant's Address : 6, rue des Iles CH-2108 COUVET Switzerland
Initial Date of Registration : 2015-05-20
Latest Date of Registration : --
NDC Package Code : 68034-100
Start Marketing Date : 2019-05-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3715
Submission : 1980-02-11
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5429
Submission : 1984-07-09
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25334
Submission : 2011-08-09
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-04
Pay. Date : 2013-09-25
DMF Number : 5046
Submission : 1983-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-08-16
Pay. Date : 2019-06-24
DMF Number : 33740
Submission : 2019-05-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16718
Submission : 2003-07-18
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-07-26
Pay. Date : 2024-06-10
DMF Number : 38878
Submission : 2023-09-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-02
Pay. Date : 2018-02-20
DMF Number : 5261
Submission : 1984-01-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-10-18
Pay. Date : 2024-09-19
DMF Number : 40427
Submission : 2024-09-04
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10232
Submission : 1993-03-06
Status : Inactive
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 : 5429
Submission : 1984-07-09
Status : Inactive
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 : 3715
Submission : 1980-02-11
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Calcium Folinate Hydrate, Amorphous
Certificate Number : CEP 2013-176 - Rev 02
Status : Valid
Issue Date : 2024-04-02
Type : Chemical
Substance Number : 978
Certificate Number : CEP 1997-051 - Rev 10
Status : Valid
Issue Date : 2024-03-06
Type : Chemical
Substance Number : 978
Certificate Number : CEP 2004-009 - Rev 04
Status : Valid
Issue Date : 2024-04-15
Type : Chemical
Substance Number : 978
Certificate Number : R1-CEP 2011-370 - Rev 00
Status : Valid
Issue Date : 2019-07-26
Type : Chemical
Substance Number : 978
Certificate Number : R1-CEP 1996-055 - Rev 08
Status : Valid
Issue Date : 2023-05-19
Type : Chemical
Substance Number : 978
Registration Number : 221MF10021
Registrant's Address : Via Figino 6,6917 Barbengo/Lugano, Switzerland
Initial Date of Registration : 2009-01-28
Latest Date of Registration : 2018-01-10
Registration Number : 227MF10147
Registrant's Address : 6, rue des Iles CH-2108 COUVET Switzerland
Initial Date of Registration : 2015-05-20
Latest Date of Registration : 2015-05-20
Registration Number : 218MF10352
Registrant's Address : Weisshausmatte CH-6460 Altdorf Switzerland
Initial Date of Registration : 2006-03-17
Latest Date of Registration : 2011-08-19
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Calcium Folinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcium Folinate, including repackagers and relabelers. The FDA regulates Calcium Folinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcium Folinate 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 Calcium Folinate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calcium Folinate supplier is an individual or a company that provides Calcium Folinate active pharmaceutical ingredient (API) or Calcium Folinate finished formulations upon request. The Calcium Folinate suppliers may include Calcium Folinate API manufacturers, exporters, distributors and traders.
click here to find a list of Calcium Folinate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calcium Folinate DMF (Drug Master File) is a document detailing the whole manufacturing process of Calcium Folinate active pharmaceutical ingredient (API) in detail. Different forms of Calcium Folinate DMFs exist exist since differing nations have different regulations, such as Calcium Folinate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calcium Folinate DMF submitted to regulatory agencies in the US is known as a USDMF. Calcium Folinate USDMF includes data on Calcium Folinate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calcium Folinate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Calcium Folinate 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 Calcium Folinate Drug Master File in Japan (Calcium Folinate JDMF) empowers Calcium Folinate 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 Calcium Folinate JDMF during the approval evaluation for pharmaceutical products. At the time of Calcium Folinate 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 Calcium Folinate suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Calcium Folinate Drug Master File in Korea (Calcium Folinate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Calcium Folinate. The MFDS reviews the Calcium Folinate KDMF as part of the drug registration process and uses the information provided in the Calcium Folinate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Calcium Folinate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Calcium Folinate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Calcium Folinate suppliers with KDMF on PharmaCompass.
A Calcium Folinate CEP of the European Pharmacopoeia monograph is often referred to as a Calcium Folinate Certificate of Suitability (COS). The purpose of a Calcium Folinate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Calcium Folinate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Calcium Folinate to their clients by showing that a Calcium Folinate CEP has been issued for it. The manufacturer submits a Calcium Folinate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Calcium Folinate CEP holder for the record. Additionally, the data presented in the Calcium Folinate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Calcium Folinate DMF.
A Calcium Folinate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Calcium Folinate 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 Calcium Folinate suppliers with CEP (COS) on PharmaCompass.
A Calcium Folinate written confirmation (Calcium Folinate WC) is an official document issued by a regulatory agency to a Calcium Folinate manufacturer, verifying that the manufacturing facility of a Calcium Folinate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Calcium Folinate APIs or Calcium Folinate finished pharmaceutical products to another nation, regulatory agencies frequently require a Calcium Folinate WC (written confirmation) as part of the regulatory process.
click here to find a list of Calcium Folinate 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 Calcium Folinate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Calcium Folinate 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 Calcium Folinate 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 Calcium Folinate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Calcium Folinate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Calcium Folinate suppliers with NDC on PharmaCompass.
Calcium Folinate 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 Calcium Folinate 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 Calcium Folinate GMP manufacturer or Calcium Folinate GMP API supplier for your needs.
A Calcium Folinate CoA (Certificate of Analysis) is a formal document that attests to Calcium Folinate's compliance with Calcium Folinate specifications and serves as a tool for batch-level quality control.
Calcium Folinate CoA mostly includes findings from lab analyses of a specific batch. For each Calcium Folinate 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.
Calcium Folinate may be tested according to a variety of international standards, such as European Pharmacopoeia (Calcium Folinate EP), Calcium Folinate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Calcium Folinate USP).
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