Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
01 1Omgene Life Sciences Pvt. Ltd
02 1Amphastar Pharmaceuticals
03 2Arrotex Pharmaceuticals
04 1GLAND PHARMA LIMITED
05 2Generic Health
06 1Lupin Ltd
07 1Meitheal Pharmaceuticals
08 1Merck & Co
09 1ORGANON CANADA INC.
10 3Organon
11 1Qilu Pharmaceutical
12 4Sun Pharmaceutical Industries Limited
13 1Theramex
14 1Tris Pharma Inc
01 8INJECTABLE;INJECTION
02 1INJEKTIONSVÄTSKA, LÖSNING
03 1Pre-Filled Syringe
04 1SOLUTION
05 1SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
06 5injection
07 4Blank
01 8RX
02 13Blank
01 2ARX Ganirelix
02 1FYREMADEL
03 7GANIRELIX ACETATE
04 2GANIRELIX SUN
05 2Ganirelix Lupin
06 1Ganirelix Theramex
07 1ORGALUTRAN
08 3Orgalutran
09 1ganirelix SUN
10 1Blank
01 9Australia
02 1Canada
03 1India
04 2Sweden
05 8USA
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 : Pre-Filled Syringe
Dosage Strength : 250MCG/0.5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : GANIRELIX ACETATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MCG/0.5ML
Packaging :
Approval Date : 2022-04-07
Application Number : 212613
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Australia
Brand Name : ARX Ganirelix
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Ganirelix Lupin
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Ganirelix Lupin
Dosage Form : injection
Dosage Strength : 250 microgram/0.5 mL
Packaging : 5
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : RX
Registration Country : USA
Brand Name : GANIRELIX ACETATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MCG/0.5ML
Packaging :
Approval Date : 2023-02-28
Application Number : 215658
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : GANIRELIX ACETATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MCG/0.5ML
Packaging :
Approval Date : 2023-11-16
Application Number : 216075
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : GANIRELIX ACETATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MCG/0.5ML
Packaging :
Approval Date : 2022-06-06
Application Number : 214996
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : Orgalutran
Dosage Form : INJEKTIONSVÄTSKA, LÖSNING
Dosage Strength : 0,25 MG/0,5 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info : RX
Registration Country : USA
Brand Name : GANIRELIX ACETATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MCG/0.5ML
Packaging :
Approval Date : 1999-07-29
Application Number : 21057
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Australia
Brand Name : Orgalutran
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Orgalutran
Dosage Form : injection
Dosage Strength : 250 microgram/0.5 mL
Packaging : 5
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : RX
Registration Country : USA
Brand Name : GANIRELIX ACETATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MCG/0.5ML
Packaging :
Approval Date : 2025-04-23
Application Number : 218855
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : FYREMADEL
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MCG/0.5ML
Packaging :
Approval Date : 2018-11-30
Application Number : 204246
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : ganirelix SUN
Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
Dosage Strength : 0.25 MG / 0.5 ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Australia
Brand Name : GANIRELIX SUN
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : GANIRELIX SUN
Dosage Form : injection
Dosage Strength : 250 microgram/0.5 mL
Packaging : 5
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Ganirelix Theramex
Dosage Form : injection
Dosage Strength : 250 microgram/0.5 mL
Packaging : 5
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info : RX
Registration Country : USA
Brand Name : GANIRELIX ACETATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MCG/0.5ML
Packaging :
Approval Date : 2025-06-27
Application Number : 219454
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Canada
Brand Name : ORGALUTRAN
Dosage Form : SOLUTION
Dosage Strength : 250MCG/0.5ML
Packaging : 0.5ML SYR
Approval Date :
Application Number : 2245641
Regulatory Info :
Registration Country : Canada
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