Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
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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
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01 7INJECTABLE;INJECTION
02 1INJEKTIONSVÄTSKA, LÖSNING
03 1Pre-Filled Syringe
04 1SOLUTION
05 1SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
06 5injection
07 4Blank
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01 7RX
02 13Blank
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01 2ARX Ganirelix
02 1FYREMADEL
03 6GANIRELIX ACETATE
04 2GANIRELIX SUN
05 2Ganirelix Lupin
06 1Ganirelix Theramex
07 1ORGALUTRAN
08 3Orgalutran
09 1ganirelix SUN
10 1Blank
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01 9Australia
02 1Canada
03 1India
04 2Sweden
05 7USA
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 : ARX Ganirelix
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 Lupin
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
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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 :
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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 :
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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