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ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 12 USDMF, 5 JDMF, 2 EU WC, 1 KDMF, 11 NDC API, 22 Listed Suppliers, $ API Reference Price

32 API Suppliers
12 USDMF
5 JDMF
2 EU WC
1 KDMF
11 NDC API
22 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

51 FDF Dossiers, 26 FDA Orange Book, 8 Europe, 4 Canada, 2 South Africa, 11 Listed Dossiers

51 FDF Dossiers
26 FDA Orange Book
8 Europe
4 Canada
2 South Africa
11 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INTRAVENOUS - EQ 100MG BASE/VIAL, INJECTABLE;INTRAVENOUS - EQ 50MG BASE/VIAL, SOLUTION;INTRAVENOUS - EQ 100MG BASE/100ML (EQ 1MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 150MG BASE/150ML (EQ 1MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 50MG BASE/50ML (EQ 1MG BASE/ML)

drugProductComposition
INJECTABLE;INTRAVENOUS - EQ 100MG BASE/VIAL
INJECTABLE;INTRAVENOUS - EQ 50MG BASE/VIAL
SOLUTION;INTRAVENOUS - EQ 100MG BASE/100ML (EQ 1MG BASE/ML)
SOLUTION;INTRAVENOUS - EQ 150MG BASE/150ML (EQ 1MG BASE/ML)
SOLUTION;INTRAVENOUS - EQ 50MG BASE/50ML (EQ 1MG BASE/ML)

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 17 NEWS #PharmaBuzz

media
3 DATA COMPILATION #PharmaFlow
17 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 6 Finished Drug Prices, 8 Annual Reports

globalSalesInformation
2 US Medicaid Prescriptions
6 Finished Drug Prices
8 Annual Reports

MARKET PLACE

9 APIs, 1 FDF Dossiers

marketPlace
9 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

7 Health Canada Patents

patents
7 Health Canada Patents

Synopsis

ACTIVE PHARMA INGREDIENTS

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CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

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API REF. PRICE (USD/KG)

$ 102,938

MARKET PLACE

API

FDF

3INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

4DRUGS 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)

8,796,583

Annual Reports (USD Million)

1,729

Finished Drug Prices

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 208538-73-2, Funguard, Mycamine, Fk463 sodium, Fk-463, Micafungin na

Molecular Formula

C₅₆H₇₀N₉NaO₂₃S

Molecular Weight

1292.3 g/mol

InChI Key

KOOAFHGJVIVFMZ-WZPXRXMFSA-M

FDA UNII

IS1UP79R56

A cyclic lipo-hexapeptide echinocandin antifungal agent that is used for the treatment and prevention of CANDIDIASIS.

1 2D Structure

Micafungin

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

sodium;[5-[(1S,2S)-2-[(3S,6S,9S,11R,15S,18S,20R,21R,24S,25S,26S)-3-[(1R)-3-amino-1-hydroxy-3-oxopropyl]-11,20,21,25-tetrahydroxy-15-[(1R)-1-hydroxyethyl]-26-methyl-2,5,8,14,17,23-hexaoxo-18-[[4-[5-(4-pentoxyphenyl)-1,2-oxazol-3-yl]benzoyl]amino]-1,4,7,13,16,22-hexazatricyclo[22.3.0.09,13]heptacosan-6-yl]-1,2-dihydroxyethyl]-2-hydroxyphenyl] sulfate

2.1.2 InChI

InChI=1S/C56H71N9O23S.Na/c1-4-5-6-17-86-32-14-11-28(12-15-32)39-21-33(63-87-39)27-7-9-29(10-8-27)49(75)58-34-20-38(70)52(78)62-54(80)45-46(72)25(2)23-65(45)56(82)43(37(69)22-41(57)71)60-53(79)44(48(74)47(73)30-13-16-36(68)40(18-30)88-89(83,84)85)61-51(77)35-19-31(67)24-64(35)55(81)42(26(3)66)59-50(34)76;/h7-16,18,21,25-26,31,34-35,37-38,42-48,52,66-70,72-74,78H,4-6,17,19-20,22-24H2,1-3H3,(H2,57,71)(H,58,75)(H,59,76)(H,60,79)(H,61,77)(H,62,80)(H,83,84,85);/q;+1/p-1/t25-,26+,31+,34-,35-,37+,38+,42-,43-,44-,45-,46-,47-,48-,52+;/m0./s1

2.1.3 InChI Key

KOOAFHGJVIVFMZ-WZPXRXMFSA-M

2.1.4 Canonical SMILES

CCCCCOC1=CC=C(C=C1)C2=CC(=NO2)C3=CC=C(C=C3)C(=O)NC4CC(C(NC(=O)C5C(C(CN5C(=O)C(NC(=O)C(NC(=O)C6CC(CN6C(=O)C(NC4=O)C(C)O)O)C(C(C7=CC(=C(C=C7)O)OS(=O)(=O)[O-])O)O)C(CC(=O)N)O)C)O)O)O.[Na+]

2.1.5 Isomeric SMILES

CCCCCOC1=CC=C(C=C1)C2=CC(=NO2)C3=CC=C(C=C3)C(=O)N[C@H]4C[C@H]([C@H](NC(=O)[C@@H]5[C@H]([C@H](CN5C(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@@H]6C[C@H](CN6C(=O)[C@@H](NC4=O)[C@@H](C)O)O)[C@@H]([C@H](C7=CC(=C(C=C7)O)OS(=O)(=O)[O-])O)O)[C@@H](CC(=O)N)O)C)O)O)O.[Na+]

2.2 Other Identifiers

2.2.1 UNII

IS1UP79R56

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Fk 463

2. Fk-463

3. Fk463

4. Micafungin

5. Mycamine

2.3.2 Depositor-Supplied Synonyms

1. 208538-73-2

2. Funguard

3. Mycamine

4. Fk463 Sodium

5. Fk-463

6. Micafungin Na

7. Micafungin Sodium Salt

8. Fk 463

9. Micafungin Sodium [usan]

10. Is1up79r56

11. Chebi:80105

12. Fk463

13. Sodium;[5-[(1s,2s)-2-[(3s,6s,9s,11r,15s,18s,20r,21r,24s,25s,26s)-3-[(1r)-3-amino-1-hydroxy-3-oxopropyl]-11,20,21,25-tetrahydroxy-15-[(1r)-1-hydroxyethyl]-26-methyl-2,5,8,14,17,23-hexaoxo-18-[[4-[5-(4-pentoxyphenyl)-1,2-oxazol-3-yl]benzoyl]amino]-1,4,7,13,16,22-hexazatricyclo[22.3.0.09,13]heptacosan-6-yl]-1,2-dihydroxyethyl]-2-hydroxyphenyl] Sulfate

14. Mycamine Sodium

15. Funguard (tn)

16. Mycamine (tn)

17. Mcfg

18. Micafungin Sodium- Bio-x

19. Unii-is1up79r56

20. Micafungin Na [vandf]

21. Micafungin Sodium (jan/usan)

22. Micafungin Sodium [jan]

23. Chembl1237070

24. Ex-a4114a

25. Micafungin Sodium [mart.]

26. Micafungin Sodium [who-dd]

27. Micafungin Sodium Salt [mi]

28. Mfcd08067752

29. S4287

30. Ccg-270668

31. Micafungin Sodium [orange Book]

32. Ac-30600

33. Bm164667

34. D02465

35. Q27149252

36. Pneumocandin A0, 1-((4r,5r)-4,5-dihydroxy-n2-(4-(5-(5-(pentyloxy)phenyl)-3-isoxazolyl)benzoyl)-l-ornithine)-4-((4s)-4-hydroxy-4-(4-hydroxy-3-(sulfooxy)phenyl)-l-threonine)-, Monosodium Salt

37. Pneumocandin A0, 1-(4r,5r)-4,5-ihydroxy-2-4-5-4-(pentyloxy)henyl]-3-soxazolyl]enzoyl]--rnithine]-4-(4s)-4-ydroxy-4-4-ydroxy-3-(sulfooxy)henyl]

2.4 Create Date

2008-02-05

3 Chemical and Physical Properties

Molecular Formula	C₅₆H₇₀N₉NaO₂₃S
Molecular Weight	1292.3 g/mol
Hydrogen Bond Donor Count	15
Hydrogen Bond Acceptor Count	24
Rotatable Bond Count	18
Exact Mass	1291.42029497 g/mol
Monoisotopic Mass	1291.42029497 g/mol
Topological Polar Surface Area	521 Å²
Heavy Atom Count	90
Formal Charge	0
Complexity	2580
Isotope Atom Count	0
Defined Atom Stereocenter Count	15
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Mycamine
PubMed Health	Micafungin (Injection)
Drug Classes	Antifungal
Drug Label	Mycamine is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma e...
Active Ingredient	Micafungin sodium
Dosage Form	Injectable
Route	injection; Iv (infusion)
Strength	100mg/vial; 50mg; 50mg/vial
Market Status	Prescription
Company	Astellas; Fujisawa Hlthcare

2 of 2
Drug Name	Mycamine
PubMed Health	Micafungin (Injection)
Drug Classes	Antifungal
Drug Label	Mycamine is a sterile, lyophilized product for intravenous (IV) infusion that contains micafungin sodium. Micafungin sodium is a semisynthetic lipopeptide (echinocandin) synthesized by a chemical modification of a fermentation product of Coleophoma e...
Active Ingredient	Micafungin sodium
Dosage Form	Injectable
Route	injection; Iv (infusion)
Strength	100mg/vial; 50mg; 50mg/vial
Market Status	Prescription
Company	Astellas; Fujisawa Hlthcare

4.2 Drug Indication

Mycamine is indicated for:

* Adults, adolescents 16 years of age and elderly:

- treatment of invasive candidiasis;

- treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate;

- prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem-cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/l) for 10 or more days.

* Children (including neonates) and adolescents < 16 years of age:

- treatment of invasive candidiasis.

The decision to use Mycamine should take into account a potential risk for the development of liver tumours. Mycamine should therefore only be used if other antifungals are not appropriate.

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antifungal Agents

Substances that destroy fungi by suppressing their ability to grow or reproduce. They differ from FUNGICIDES, INDUSTRIAL because they defend against fungi present in human or animal tissues. (See all compounds classified as Antifungal Agents.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Lipopeptides [CS]; Echinocandin Antifungal [EPC]

5.3 ATC Code

J02AX05

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SOLA BRIDGE,,","city":"AHMEDABAD,GUJARAT","supplier":"XXDICXXM MXXUFAXXURIXX MAXXA, XXD.","supplierCountry":"MALTA","foreign_port":"MALTA (VALLETTA)","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"92862.5","totalValueFC":"375887.7","currency":"USD","unitRateINR":"7832952","date":"16-May-2024","totalValueINR":"31331808","totalValueInUsd":"375887.7","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29419090","bill_no":"1001784","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA (VALLETTA)","supplierAddress":"N\/A","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"MICAFUNGIN SODIUM","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"ZHEJIANG HISUN PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"0.37","actualQuantity":"0.37","unit":"KGS","unitRateFc":"50000","totalValueFC":"18796.1","currency":"USD","unitRateINR":"4257123.5","date":"05-Sep-2024","totalValueINR":"1575135.7","totalValueInUsd":"18796.1","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"5441453","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"NO.46 WAISHA ROAD, JIAOJIANG, TAIZHOU, ZHEJIANG, P.R.CHINA SDNF CN","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"MICAFUNGIN SODIUM","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"MEDICHEM S.A","supplierCountry":"MALTA","foreign_port":"MALTA","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"0.03","unit":"KGS","unitRateFc":"85000","totalValueFC":"2581.9","currency":"USD","unitRateINR":"7212250","date":"05-Sep-2024","totalValueINR":"216367.5","totalValueInUsd":"2581.9","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"5438628","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA","supplierAddress":"HF 61, HAL FAR INDUSTRIAL ESTATE BB G-3000, HAL FAR, MALTA HAL FAR, , M alta Malta Malta","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"MICAFUNGIN SODIUM","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR","city":"AHMEDABAD\/GUJRAT","supplier":"MEDICHEM S.A","supplierCountry":"MALTA","foreign_port":"MALTA","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"0.06","actualQuantity":"0.06","unit":"KGS","unitRateFc":"85000","totalValueFC":"5163.8","currency":"USD","unitRateINR":"7212250","date":"05-Sep-2024","totalValueINR":"432735","totalValueInUsd":"5163.8","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"5438628","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA","supplierAddress":"HF 61, HAL FAR INDUSTRIAL ESTATE BB G-3000, HAL FAR, MALTA HAL FAR, , M alta Malta Malta","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726425000,"product":"MICAFUNGIN SODIUM (LOT - 204240021)","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"MEDICHEM MANUFACTURING MALTA, LTD","supplierCountry":"MALTA","foreign_port":"MALTA (VALETTA)","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"4.91","actualQuantity":"4.905","unit":"KGS","unitRateFc":"85000","totalValueFC":"422391.6","currency":"USD","unitRateINR":"7216500","date":"16-Sep-2024","totalValueINR":"35396932.5","totalValueInUsd":"422391.6","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29419090","bill_no":"5622273","productDescription":"API","marketType":"REGULATED MARKET","country":"MALTA","selfForZScoreResived":"Pharma Grade","supplierPort":"MALTA (VALETTA)","supplierAddress":"HF 61, Hal Far Industrial Estate BBG-3000, Hal Far, Malta SDNF Malta","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732818600,"product":"MICAFUNGIN SODIUM (1000 G) (LIST 3 SR NO 114) (LIST 1 SR NO114 FOR GST)","address":"2NF FLOOR,BUILDING A,","city":"ANDHERI[W],MUMBAI,","supplier":"BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO.,LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"GUFIC BIOSCIENCES","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1000","unit":"GMS","unitRateFc":"56","totalValueFC":"56638.3","currency":"USD","unitRateINR":"4779.6","date":"29-Nov-2024","totalValueINR":"4779600","totalValueInUsd":"56638.3","indian_port":"Madras Air","hs_no":"29419090","bill_no":"6950971","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"ADD:BUILDING C25-C28 NO 218 XINGHU ROAD SIP SUZHOU JIANGSU CHINA SDNF CHINA","customerAddress":"2NF FLOOR,BUILDING A,"}]

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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Drugs in Development

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - INJECTABLE;INTRAVENOUS - EQ 100MG BA...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 100MG BASE/VIAL

USFDA APPLICATION NUMBER - 21506

DOSAGE - INJECTABLE;INTRAVENOUS - EQ 50MG BAS...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 50MG BASE/VIAL

USFDA APPLICATION NUMBER - 21506

DOSAGE - SOLUTION;INTRAVENOUS - EQ 100MG BASE...DOSAGE - SOLUTION;INTRAVENOUS - EQ 100MG BASE/100ML (EQ 1MG BASE/ML)

USFDA APPLICATION NUMBER - 216142

DOSAGE - SOLUTION;INTRAVENOUS - EQ 150MG BASE...DOSAGE - SOLUTION;INTRAVENOUS - EQ 150MG BASE/150ML (EQ 1MG BASE/ML)

USFDA APPLICATION NUMBER - 216142

DOSAGE - SOLUTION;INTRAVENOUS - EQ 50MG BASE/...DOSAGE - SOLUTION;INTRAVENOUS - EQ 50MG BASE/50ML (EQ 1MG BASE/ML)

USFDA APPLICATION NUMBER - 216142

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DATA COMPILATION #PharmaFlow

NEWS #PharmaBuzz

Manufacturing and Marketing Approval for Three Ingredients and Eight Items

15 Feb 2024

// PRESS RELEASE

Sandoz completes acquisition of leading antifungal agent Mycamine® from Astellas

28 Aug 2023

// GLOBENEWSWIRE

Enforcement Report - Week of February 22, 2023

22 Feb 2023

// FDA

Sandoz signs deal for antifungal from Astellas in buff-up of anti-infectives

25 Jan 2023

// Paul Schloesser ENDPTS

USFDA approves Zydus Lifesciences to market generic Micafungin injection

25 Oct 2022

// ECONOMIC TIMES

Zydus's Generic Micafungin Sodium Receives Approval in the U.S.

24 Oct 2022

// FDA

Global Sales Information

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US Medicaid Prescriptions

01

Brand Name : Micafungin

Country

Duphat

Not Confirmed

Not Confirmed

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Finished Drug Prices

01

Brand Name : Mycamine

Japan

Duphat

Not Confirmed

Micafungin Sodium

Duphat

Not Confirmed

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Market Place

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APIs

Micafungin (200 g - 400 g) API needed in India [ENA21287]

A company that focuses on manufacturing of various finished formulations is looking for suppliers of IP/ BP/ USP Grade Micafungin (200 g - 400 g) API for development purposes. The suppliers must support this enquiry with CoA.

02 Dec 2024

Various APIs needed in India [ENA14299]

A company that deals in various pharmaceutical products like injections, syrups & hygiene products is looking for suppliers of Various APIs for commercial purpose. The suppliers must support this enquiry with CoA. 1. Hydroxychloroquine (25 kg) API 2. Micafungin (2 kg) API 3. Cetrimonium Bromide (2 kg) API

11 Jul 2022

Lyophilized Micafungin & Micronized Progesterone APIs needed in Indonesia [ENA11563]

A leading pharmaceutical company that deals in the development & manufacturing of CNS, dermatological, endocrine, gastrointestinal, genitourinary, anti-infective, herbal & phytopharmaceutical products is looking for suppliers of Lyophilized Micafungin & Micronized Progesterone APIs for development purpose. The required quantity is MOQ for each.

05 Oct 2021

Various APIs needed in India [ENA09702]

India’s single largest Contract Research and Manufacturing (CRAMS) organization is looking for suppliers of Various APIs for development purposes. The required quantity is MOQ for each. The suppliers must support this enquiry with CoA. 1. USP Grade Tigecycline API 2. Sterile & Lyophilized Micafungin Sodium API 3. Sterile Ceftaroline Fosamil API

10 Feb 2021

Remdesivir & Lyophilized Micafungin APIs needed in India [ENA09345]

A company offering a broad and integrated portfolio of products & services to the global pharmaceutical industry is looking for suppliers of Remdesivir (10 kg, 20 kg lot in 15 days) & Lyophilized Micafungin (100 g for development and 1 kg for commercial purposes) APIs. The suppliers must support this enquiry with GMP. The final market is ROW, South East Asia and non-regulated market.

23 Dec 2020

Various APIs needed in India [ENA07154]

Janya Biocare, a company based in India is looking for Various APIs. 1. Favipiravir 2. Amphotericin B 3. Micafungin Interested suppliers can contact them via their email: janyabiocare@gmail.com.

24 Apr 2020

Micafungin, Caspofungin and Canagliflozin API (20 kg each) needed in China [ENA02994]

Atomax Chemicals Co., Ltd is looking for suppliers of Micafungin, Caspofungin and Canagliflozin API (20 kg each). Interested suppliers can contact Victor Lo via Email: victor.lo@atomaxchem.com or Tel: 0086 755 3323 9182.

20 Dec 2018

Enquiry//CPhI Barcelona Meetings with suppliers supporting U.S. DMFs [ENA00093]

A focused Contract Research & Development organization, based in India providing formulation development services for the regulated markets is looking to meet suppliers at CPhI Barcelona who already support USDMFs for the following products: 1 Acetaminophen 2 Atropine sulphate 3 Benzoic Acid / Phenylacetic acid 4 Biotin 5 Busulfan 6 Carnitine 7 Cisatracurium Besilate 8 Clevidipine 9 Desmopressin 10 Dicyclomine hydrochloride 11 Esomeprazole Sodium 12 Ethacrynic Acid 13 Fluphenazine Decanoate 14 Furosemide 15 Glycopyrrolate 16 Hyaluronic Acid (As Sodium Hyaluronate) 17 Lacosamide 18 Leucovorin (Calcium folinate) 19 Levoleucovorin (Calcium Levofolinate) 20 Melphalan 21 Melphalan Hcl 22 Micafungin 23 Mitomycin 24 Nelarabine 25 Neostigmine/Neostigmine methylsulfate 26 Prochlorperazine Edisylate 27 Protamine sulfate 28 Sodium Nitroprusside 29 Succinylcholine chloride 30 Tranexamic Acid 31 Tromethamine 32 Ziprasidone Mesylate

16 Sep 2016

Enquiry// Sterile Injectable start-up in India is searching for suppliers for regulated markets [EN00272][EN00273][EN00274][EN00275][EN00276][EN00277][EN00278]

A start-up based in India with a focus on sterile injectable manufacturing is searching for suppliers of Caspofungin Acetate, Dexmedetomidine HCL, Fondaparinux Sodium, Enoxaparin Sodium, Dalteparin Sodium, Cosyntropin & Micafungin. The company has plans to develop over 300 products for the regulated markets in the coming two years and is looking for suppliers who can ensure sustainable long-term supplies.

03 Feb 2016

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ABOUT THIS PAGE

Micafungin Sodium Manufacturers

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

Micafungin Sodium Suppliers

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

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

Micafungin Sodium USDMF

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

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

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

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

Micafungin Sodium KDMF

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

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

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

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

Micafungin Sodium WC

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

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

Micafungin Sodium 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 Micafungin Sodium as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Micafungin Sodium 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 Micafungin Sodium 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 Micafungin Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Micafungin Sodium NDC to their finished compounded human drug products, they may choose to do so.

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

Micafungin Sodium GMP

Micafungin Sodium 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 Micafungin Sodium 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 Micafungin Sodium GMP manufacturer or Micafungin Sodium GMP API supplier for your needs.

Micafungin Sodium CoA

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

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

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

Find Micafungin manufacturers, exporters & distributors on PharmaCompass

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

32 API Suppliers

12 USDMF

5 JDMF

2 EU WC

1 KDMF

11 NDC API

22 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

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INTERMEDIATES

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FINISHED DOSAGE FORMULATIONS

51 FDF Dossiers

26 FDA Orange Book

8 Europe

4 Canada

2 South Africa

11 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INTRAVENOUS - EQ 100MG BASE/VIAL

INJECTABLE;INTRAVENOUS - EQ 50MG BASE/VIAL

SOLUTION;INTRAVENOUS - EQ 100MG BASE/100ML (EQ 1MG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 150MG BASE/150ML (EQ 1MG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 50MG BASE/50ML (EQ 1MG BASE/ML)

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6 Finished Drug Prices

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1 FDF Dossiers

PATENTS & EXCLUSIVITIES

7 Health Canada Patents

ACTIVE PHARMA INGREDIENTS

API REF. PRICE (USD/KG)

$ 102,938

MARKET PLACE

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PATENTS & EXCLUSIVITIES

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Brand Name : Mycamine

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Brand Name : Mycamine

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Brand Name : Mycamine

Brand Name : Mycamine

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