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ACTIVE PHARMA INGREDIENTS

20 API Suppliers, 10 USDMF, 5 CEP/COS, 3 JDMF, 1 EU WC, 2 KDMF, 19 NDC API, 11 Listed Suppliers, $ API Reference Price

20 API Suppliers
10 USDMF
5 CEP/COS
3 JDMF
1 EU WC
2 KDMF
19 NDC API
11 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

64 Drugs in Development

64 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

188 FDF Dossiers, 85 FDA Orange Book, 53 Europe, 4 Australia, 6 South Africa, 40 Listed Dossiers

188 FDF Dossiers
85 FDA Orange Book
53 Europe
4 Australia
6 South Africa
40 Listed Dossiers

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 4 SPI Pharma, 2 Seqens, 7 DKSH, 5 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 20 BASF, 10 Corel Pharma Chem, 5 DFE Pharma, 1 Finar, 8 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 6 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 18 Roquette, 7 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

69 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 31 Controlled & Modified Release, 30 Direct Compression, 26 Thickeners and Stabilizers, 21 Disintegrants & Superdisintegrants, 20 Granulation, 16 Lubricants & Glidants, 14 Co-Processed Excipients, 13 Parenteral, 11 Film Formers & Plasticizers, 11 Solubilizers, 10 Topical, 9 Empty Capsules, 9 Taste Masking, 6 Chewable & Orodispersible Aids, 5 API Stability Enhancers, 4 Vegetarian Capsules, 4 Coloring Agents, 4 Emulsifying Agents, 3 Rheology Modifiers

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 19 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
19 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

52 Finished Drug Prices, 1 Annual Reports

globalSalesInformation
52 Finished Drug Prices
1 Annual Reports

MARKET PLACE

14 APIs, 7 FDF Dossiers

marketPlace
14 APIs
7 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 USP , 1 JP , 1 Others

otherSolutions
1 USP
1 JP
1 Others

Rochem Calcium Folinate

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 2,262

MARKET PLACE

API

FDF

1INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

188

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

64DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

Annual Reports (USD Million)

Finished Drug Prices

228 RELATED EXCIPIENT COMPANIES

369EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Calcium folinate, Calcium citrovorum factor, Folinic acid calcium salt, Folinic acid-sf, calcium salt, (+)-l-folinic acid, calcium salt, 1492-18-8

Molecular Formula

C₂₀H₂₃CaN₇O₇+₂

Molecular Weight

513.5 g/mol

InChI Key

KVUAALJSMIVURS-ZEDZUCNESA-N

The active metabolite of FOLIC ACID. Leucovorin is used principally as an antidote to FOLIC ACID ANTAGONISTS.

1 2D Structure

Calcium Folinate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

calcium;(2S)-2-[[4-[(2-amino-5-formyl-4-oxo-3,6,7,8-tetrahydropteridin-6-yl)methylamino]benzoyl]amino]pentanedioic acid

2.1.2 InChI

InChI=1S/C20H23N7O7.Ca/c21-20-25-16-15(18(32)26-20)27(9-28)12(8-23-16)7-22-11-3-1-10(2-4-11)17(31)24-13(19(33)34)5-6-14(29)30;/h1-4,9,12-13,22H,5-8H2,(H,24,31)(H,29,30)(H,33,34)(H4,21,23,25,26,32);/q;+2/t12?,13-;/m0./s1

2.1.3 InChI Key

KVUAALJSMIVURS-ZEDZUCNESA-N

2.1.4 Canonical SMILES

C1C(N(C2=C(N1)N=C(NC2=O)N)C=O)CNC3=CC=C(C=C3)C(=O)NC(CCC(=O)O)C(=O)O.[Ca+2]

2.1.5 Isomeric SMILES

C1C(N(C2=C(N1)N=C(NC2=O)N)C=O)CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(=O)O)C(=O)O.[Ca+2]

2.2 Synonyms

2.2.1 MeSH Synonyms

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

2.2.2 Depositor-Supplied Synonyms

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)-

2.3 Create Date

2019-01-15

3 Chemical and Physical Properties

Molecular Formula	C₂₀H₂₃CaN₇O₇+₂
Molecular Weight	513.5 g/mol
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 Å²
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

4 Pharmacology and Biochemistry

4.1 MeSH Pharmacological Classification

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.)

4.2 ATC Code

V - Various

V03 - All other therapeutic products

V03A - All other therapeutic products

V03AF - Detoxifying agents for antineoplastic treatment

V03AF03 - Calcium folinate

API SUPPLIERS

01

Rochem International Inc

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Attending

Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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U.S.A

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

Sichuan Huiyu Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PharmaVenue

Not Confirmed

03

Huzhou Zhanwang Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PharmaVenue

Not Confirmed

04

MERCK & CIE

Switzerland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PharmaVenue

Not Confirmed

MERCK & CIE

Switzerland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PharmaVenue

Not Confirmed

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Switzerland

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USDMF

CEP/COS

JDMF

EU-WC NDC

KDMF

VMF Others AUDIT

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

05

GMT Fine Chemicals SA

Switzerland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PharmaVenue

Not Confirmed

06

Cerbios-Pharma SA

Switzerland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PharmaVenue

Not Confirmed

Cerbios-Pharma SA

Switzerland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Not Confirmed

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Switzerland

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USDMF

CEP/COS

JDMF

EU-WC NDC

KDMF

VMF Others AUDIT

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Corporate PDF

07

ALP Pharm

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PharmaVenue

Not Confirmed

08

GMT Fine Chemicals SA

Switzerland

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PharmaVenue

Not Confirmed

09

Country

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

PharmaVenue

Not Confirmed

10

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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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CEP/COS

01

Cerbios-Pharma SA Barbengo CH

Switzerland

Switzerland

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EU WC

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NDC API

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Listed Suppliers

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API Reference Price

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Export","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1674844200,"product":"LEUCOVORIN CALCIUM USP","address":"125 & 126 SIPCOT INDUSTRIAL COMPLE X,HOSUR, KRISHNAGIRI DIST, TAMILNAD","city":"HOSUR,TAMIL NADU","supplier":"GLOBAL CALCIUM","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"TO THE ORDER OF","customerCountry":"SPAIN","quantity":"10.80","actualQuantity":"10.8","unit":"KGS","unitRateFc":"2326","totalValueFC":"24743.3","currency":"USD","unitRateINR":187314.8148148148,"date":"28-Jan-2023","totalValueINR":"2023000","totalValueInUsd":"24743.3","indian_port":"BANGALORE AIR","hs_no":"29362990","bill_no":"7337997","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BANGALORE AIR","supplierAddress":"125 & 126 SIPCOT INDUSTRIAL COMPLE X,HOSUR, KRISHNAGIRI DIST, TAMILNAD, HOSUR,TAMIL NADU","customerAddress":""},{"dataSource":"API 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GROUP","supplierCountry":"SWITZERLAND","foreign_port":"ZURICH","customer":"VIATRIS","customerCountry":"INDIA","quantity":"26.76","actualQuantity":"26.76","unit":"KGS","unitRateFc":"3808","totalValueFC":"102991.4","currency":"USD","unitRateINR":"321395.2","date":"29-Apr-2024","totalValueINR":"8600535.55","totalValueInUsd":"102991.4","indian_port":"Bangalore Air","hs_no":"29362990","bill_no":"3259681","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Crystalline","supplierPort":"ZURICH","supplierAddress":"Im Laternenacker 5, 8200 Schaffhausen,SDNF Switzerland","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718217000,"product":"CALCIUM FOLINATE\/LEUCOVORIN CALCIUM IP ( LIST 04 SR NO. 21 )","address":"304,TOWN CENTRE,","city":"MUMBAI \/ MAHARASHTRA","supplier":"CERBIOS-PHARMA SA","supplierCountry":"SWITZERLAND","foreign_port":"ZURICH","customer":"NAPROD LIFE SCIENCES","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"3000","totalValueFC":"60589.8","currency":"USD","unitRateINR":"252900","date":"13-Jun-2024","totalValueINR":"5058000","totalValueInUsd":"60589.8","indian_port":"Bombay Air","hs_no":"29362990","bill_no":"3974714","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"ZURICH","supplierAddress":"VIA FIGINO 6, 6917 BARBENGO \/LUGANOSWITZERLAND SWITZERLAND","customerAddress":"304,TOWN CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718217000,"product":"CALCIUM FOLINATE\/LEUCOVORIN CALCIUM IP ( LIST 04 SR NO. 21 )","address":"304,TOWN CENTRE,","city":"MUMBAI \/ MAHARASHTRA","supplier":"CERBIOS-PHARMA SA","supplierCountry":"SWITZERLAND","foreign_port":"ZURICH","customer":"NAPROD LIFE SCIENCES","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"3000","totalValueFC":"90884.7","currency":"USD","unitRateINR":"252900","date":"13-Jun-2024","totalValueINR":"7587000","totalValueInUsd":"90884.7","indian_port":"Bombay Air","hs_no":"29362990","bill_no":"3974714","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"ZURICH","supplierAddress":"VIA FIGINO 6, 6917 BARBENGO \/LUGANOSWITZERLAND SWITZERLAND","customerAddress":"304,TOWN CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721413800,"product":"CALCIUM FOLINATE HYDRATE EP\/LEUCOVORIN CALCIUM USP","address":"PLOT NO. 87-96, SY.NO. 174 (P),","city":"R.R. DIST, HYDERABAD","supplier":"GMT FINE CHEMICALS SA","supplierCountry":"SWITZERLAND","foreign_port":"ZURICH","customer":"ZENARA PHARMA","customerCountry":"INDIA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"4600","totalValueFC":"13958.3","currency":"USD","unitRateINR":"388930","date":"20-Jul-2024","totalValueINR":"1166790","totalValueInUsd":"13958.3","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"4608561","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"ZURICH","supplierAddress":"RUE DES LLES 62108 COUVETSDNF CH","customerAddress":"PLOT NO. 87-96, SY.NO. 174 (P),"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724437800,"product":"CALCIUM FOLINATE PH EUR","address":"NO.18,DR NAIR ROAD, T NAGAR,","city":"CHENNAI","supplier":"BIOFER","supplierCountry":"ITALY","foreign_port":"BOLOGNA","customer":"STERIL-GENE LIFE SCIENCES (P) LTD","customerCountry":"INDIA","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"2200","totalValueFC":"36923","currency":"EUR","unitRateINR":"206470","date":"24-Aug-2024","totalValueINR":"3097050","totalValueInUsd":"36923","indian_port":"Madras Air","hs_no":"29420090","bill_no":"5226759","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"BOLOGNA","supplierAddress":"VIA TOMMASO DACAZZANIGA 9\/6 20121MILANO (MI) ITALY","customerAddress":"NO.18,DR NAIR ROAD, T NAGAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724956200,"product":"CALCIUM FOLINATE\/LEUCOVORIN CALCIUM IP ( LIST 04 SR NO. 21 )","address":"304,TOWN CENTRE,","city":"MUMBAI \/ MAHARASHTRA","supplier":"CERBIOS-PHARMA SA","supplierCountry":"SWITZERLAND","foreign_port":"ZURICH","customer":"NAPROD LIFE SCIENCES","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"3000","totalValueFC":"91042.4","currency":"USD","unitRateINR":"254550","date":"30-Aug-2024","totalValueINR":"7636500","totalValueInUsd":"91042.4","indian_port":"Bombay Air","hs_no":"29362990","bill_no":"5329140","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"ZURICH","supplierAddress":"VIA FIGINO 6, 6917 BARBENGO \/LUGANOSWITZERLAND SWITZERLAND","customerAddress":"304,TOWN CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725647400,"product":"CALCIUM FOLINATE HYDRATE EP (LOT NO:C00046)","address":"LINCOLN HOUSE, B\/H SATYAM","city":"AHMEDABAD ,GUJARAT","supplier":"CERBIOS-PHARMA SA","supplierCountry":"SWITZERLAND","foreign_port":"ZURICH","customer":"LINCOLN PHARMACEUTICALS","customerCountry":"INDIA","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"4500","totalValueFC":"13677","currency":"USD","unitRateINR":"382050","date":"07-Sep-2024","totalValueINR":"1146150","totalValueInUsd":"13677","indian_port":"Ahmedabad Air","hs_no":"29362990","bill_no":"5480281","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"ZURICH","supplierAddress":"VIA FIGINO 6 6917 BARBENGO \/ LUGANO SWITZERLAND CH CH","customerAddress":"LINCOLN HOUSE, B\/H SATYAM"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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ABOUT THIS PAGE

Leucovorin Manufacturers

A Leucovorin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Leucovorin, including repackagers and relabelers. The FDA regulates Leucovorin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Leucovorin 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 Leucovorin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Leucovorin Suppliers

A Leucovorin supplier is an individual or a company that provides Leucovorin active pharmaceutical ingredient (API) or Leucovorin finished formulations upon request. The Leucovorin suppliers may include Leucovorin API manufacturers, exporters, distributors and traders.

click here to find a list of Leucovorin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Leucovorin USDMF

A Leucovorin DMF (Drug Master File) is a document detailing the whole manufacturing process of Leucovorin active pharmaceutical ingredient (API) in detail. Different forms of Leucovorin DMFs exist exist since differing nations have different regulations, such as Leucovorin USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Leucovorin DMF submitted to regulatory agencies in the US is known as a USDMF. Leucovorin USDMF includes data on Leucovorin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Leucovorin USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Leucovorin suppliers with USDMF on PharmaCompass.

Leucovorin JDMF

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 Leucovorin Drug Master File in Japan (Leucovorin JDMF) empowers Leucovorin 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 Leucovorin JDMF during the approval evaluation for pharmaceutical products. At the time of Leucovorin 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 Leucovorin suppliers with JDMF on PharmaCompass.

Leucovorin KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Leucovorin Drug Master File in Korea (Leucovorin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Leucovorin. The MFDS reviews the Leucovorin KDMF as part of the drug registration process and uses the information provided in the Leucovorin KDMF to evaluate the safety and efficacy of the drug.

After submitting a Leucovorin 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 Leucovorin API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Leucovorin suppliers with KDMF on PharmaCompass.

Leucovorin CEP

A Leucovorin CEP of the European Pharmacopoeia monograph is often referred to as a Leucovorin Certificate of Suitability (COS). The purpose of a Leucovorin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Leucovorin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Leucovorin to their clients by showing that a Leucovorin CEP has been issued for it. The manufacturer submits a Leucovorin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Leucovorin CEP holder for the record. Additionally, the data presented in the Leucovorin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Leucovorin DMF.

A Leucovorin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Leucovorin 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 Leucovorin suppliers with CEP (COS) on PharmaCompass.

Leucovorin WC

A Leucovorin written confirmation (Leucovorin WC) is an official document issued by a regulatory agency to a Leucovorin manufacturer, verifying that the manufacturing facility of a Leucovorin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Leucovorin APIs or Leucovorin finished pharmaceutical products to another nation, regulatory agencies frequently require a Leucovorin WC (written confirmation) as part of the regulatory process.

click here to find a list of Leucovorin suppliers with Written Confirmation (WC) on PharmaCompass.

Leucovorin NDC

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 Leucovorin as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Leucovorin API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Leucovorin 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Leucovorin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Leucovorin NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Leucovorin suppliers with NDC on PharmaCompass.

Leucovorin GMP

Leucovorin 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 Leucovorin 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 Leucovorin GMP manufacturer or Leucovorin GMP API supplier for your needs.

Leucovorin CoA

A Leucovorin CoA (Certificate of Analysis) is a formal document that attests to Leucovorin's compliance with Leucovorin specifications and serves as a tool for batch-level quality control.

Leucovorin CoA mostly includes findings from lab analyses of a specific batch. For each Leucovorin 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.

Leucovorin may be tested according to a variety of international standards, such as European Pharmacopoeia (Leucovorin EP), Leucovorin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Leucovorin USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

20 API Suppliers

10 USDMF

5 CEP/COS

3 JDMF

1 EU WC

2 KDMF

19 NDC API

11 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

64 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

188 FDF Dossiers

85 FDA Orange Book

53 Europe

4 Australia

6 South Africa

40 Listed Dossiers

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53 Coating Systems & Additives

31 Controlled & Modified Release

30 Direct Compression

26 Thickeners and Stabilizers

21 Disintegrants & Superdisintegrants

20 Granulation

16 Lubricants & Glidants

14 Co-Processed Excipients

13 Parenteral

11 Film Formers & Plasticizers

11 Solubilizers

10 Topical

9 Empty Capsules

9 Taste Masking