Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
01 2Omgene Life Sciences Pvt. Ltd
02 2Polfa Tarchomin
03 2Apotex Inc
04 15Astellas Pharma
05 3Baxter Healthcare Corporation
06 2Biocon
07 2ENDO OPERATIONS
08 2Fresenius Kabi USA
09 2Hansoh Pharma
10 2Health Biotech
11 4Hikma Pharmaceuticals
12 1Kaliberr Labs
13 2Meitheal Pharmaceuticals
14 2Polifarma
15 2Rajasthan Antibiotics
16 2Teva Pharmaceutical Industries
17 2Xellia Pharmaceuticals ApS
18 2Zydus Pharmaceuticals
01 2Dry Sub
02 1INJECTABLE; INJECTION
03 18INJECTABLE;INTRAVENOUS
04 3Injection
05 2Lyophilised Injection
06 1Micafungin 100Mg 10Ml 1 Units Parenteral Use
07 1Micafungin 50Mg 10Ml 1 Units Parenteral Use
08 2POI
09 4POWDER FOR SOLUTION
10 4POWDER;INTRAVENOUS
11 2PULVER TILL INFUSIONSVÄTSKA, LÖSNING
12 2Powder for Infusion Solution
13 2Powder for Solution for IV Infusion
14 2Powder for infusion fluid, resolution
15 3SOLUTION;INTRAVENOUS
16 2Vial
01 4DISCN
02 2Dossier Availability: Q3 2024
03 2Originator
04 21RX
05 22Blank
01 4MICAFUNGIN
02 3MICAFUNGIN IN SODIUM CHLORIDE 0.9%
03 16MICAFUNGIN SODIUM
04 2MICAFUNGIN SODIUM FOR INJECTION
05 5MYCAMINE
06 8Mycamine
07 1Mycamine 100
08 1Mycamine 50
09 11Blank
01 4Canada
02 7India
03 2Italy
04 2Norway
05 2Poland
06 2South Africa
07 2Sweden
08 2Switzerland
09 2Turkey
10 26USA
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Regulatory Info : Dossier Availability: Q3 2024
Registration Country : Poland
Brand Name :
Dosage Form : Powder for Infusion Solution
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Dossier Availability: Q3 2024
Registration Country : Poland
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.
Regulatory Info : Dossier Availability: Q3 2024
Registration Country : Poland
Brand Name :
Dosage Form : Powder for Infusion Solution
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Dossier Availability: Q3 2024
Registration Country : Poland
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MICAFUNGIN SODIUM
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2020-11-05
Application Number : 208366
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MICAFUNGIN SODIUM
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 100MG BASE/VIAL
Packaging :
Approval Date : 2020-11-05
Application Number : 208366
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MYCAMINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2005-03-16
Application Number : 21506
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MYCAMINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 100MG BASE/VIAL
Packaging :
Approval Date : 2006-06-27
Application Number : 21506
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : MYCAMINE
Dosage Form : INJECTABLE; INJECTION
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number : 21754
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MICAFUNGIN IN SODIUM CHLORIDE 0.9%
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : EQ 50MG BASE/50ML (EQ 1MG BASE/ML)
Packaging :
Approval Date : 2023-09-29
Application Number : 216142
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MICAFUNGIN IN SODIUM CHLORIDE 0.9%
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : EQ 100MG BASE/100ML (EQ 1MG BASE/ML)
Packaging :
Approval Date : 2023-09-29
Application Number : 216142
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MICAFUNGIN IN SODIUM CHLORIDE 0.9%
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : EQ 150MG BASE/150ML (EQ 1MG BASE/ML)
Packaging :
Approval Date : 2023-09-29
Application Number : 216142
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MICAFUNGIN SODIUM
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2024-05-29
Application Number : 216438
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MICAFUNGIN SODIUM
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 100MG BASE/VIAL
Packaging :
Approval Date : 2024-05-29
Application Number : 216438
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MICAFUNGIN SODIUM
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2019-05-17
Application Number : 207344
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MICAFUNGIN SODIUM
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 100MG BASE/VIAL
Packaging :
Approval Date : 2019-05-17
Application Number : 207344
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MICAFUNGIN SODIUM
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2021-07-09
Application Number : 213363
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MICAFUNGIN SODIUM
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 100MG BASE/VIAL
Packaging :
Approval Date : 2021-07-09
Application Number : 213363
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MICAFUNGIN SODIUM
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2021-07-09
Application Number : 213261
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MICAFUNGIN SODIUM
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 100MG BASE/VIAL
Packaging :
Approval Date : 2021-07-09
Application Number : 213261
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MICAFUNGIN SODIUM
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2022-09-28
Application Number : 215381
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MICAFUNGIN SODIUM
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 100MG BASE/VIAL
Packaging :
Approval Date : 2022-09-28
Application Number : 215381
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MICAFUNGIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2021-07-30
Application Number : 212125
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MICAFUNGIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : EQ 100MG BASE/VIAL
Packaging :
Approval Date : 2021-07-30
Application Number : 212125
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MICAFUNGIN SODIUM
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2021-06-02
Application Number : 211713
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MICAFUNGIN SODIUM
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 100MG BASE/VIAL
Packaging :
Approval Date : 2021-06-02
Application Number : 211713
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MICAFUNGIN SODIUM
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2022-10-24
Application Number : 215241
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MICAFUNGIN SODIUM
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : EQ 100MG BASE/VIAL
Packaging :
Approval Date : 2022-10-24
Application Number : 215241
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MICAFUNGIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : EQ 50MG BASE/VIAL
Packaging :
Approval Date : 2021-06-16
Application Number : 212156
Regulatory Info : RX
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : RX
Registration Country : USA
Brand Name : MICAFUNGIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : EQ 100MG BASE/VIAL
Packaging :
Approval Date : 2021-06-16
Application Number : 212156
Regulatory Info : RX
Registration Country : USA
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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