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 2Alphapharm PTY Ltd
03 1Amphastar Pharmaceuticals
04 2Arrotex Pharmaceuticals
05 1Future Health Pharma Gmbh
06 1GLAND PHARMA LIMITED
07 1GP Pharm
08 5Gedeon Richter
09 2Generic Health
10 1JV Healthcare Limited
11 1Labatec Pharm
12 1Lupin Ltd
13 1Meitheal Pharmaceuticals
14 1ORGANON CANADA
15 4ORIFARM GROUP AS
16 7Organon
17 1Paranova Pharmaceuticals Ab
18 1Qilu Pharmaceutical
19 7Sun Pharmaceutical Industries Limited
20 2Theramex
21 1Tris Pharma Inc
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01 8INJECTABLE;INJECTION
02 6Injectable Solution
03 2Injectable Solution In Pre-Filled Syringe
04 1Pre-Filled Syringe
05 1SOLUTION
06 17Solution For Injection
07 5injection
08 4Blank
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01 3Allowed
02 4Approved
03 1Authorised
04 5Authorized
05 2Deregistered
06 6Marketed
07 4Prescription
08 8RX
09 11Blank
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01 2ARX Ganirelix
02 1Astarte
03 1FYREMADEL
04 3Firefighter
05 2Fireman's hut
06 2Fyremadel
07 7GANIRELIX ACETATE
08 2GANIRELIX SUN
09 1Ganirelix Acetate
10 5Ganirelix Gedeon Richter
11 1Ganirelix Labatec
12 2Ganirelix Lupin
13 3Ganirelix Orifarm
14 2Ganirelix Theramex
15 1ORGALUTRAN
16 7Orgalutran
17 1Orgalutran®
18 1Ovamex
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01 9Australia
02 1Canada
03 3Estonia
04 1India
05 1Malta
06 1Moldova
07 6Norway
08 5Spain
09 6Sweden
10 3Switzerland
11 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 : Ganirelix Acetate
Dosage Form : Pre-Filled Syringe
Dosage Strength : 250MCG/0.5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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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

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Ganirelix Gedeon Richter
Dosage Form : Solution For Injection
Dosage Strength : 0.25mg/0.5ml
Packaging :
Approval Date : 15/07/2022
Application Number : 20210306000039
Regulatory Info : Approved
Registration Country : Sweden

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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

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Ganirelix Labatec
Dosage Form : Injectable Solution
Dosage Strength : 0.25mg/5ml
Packaging :
Approval Date : 04/08/2022
Application Number : 68549
Regulatory Info : Allowed
Registration Country : Switzerland

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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

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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

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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

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Orgalutran
Dosage Form : Injectable Solution
Dosage Strength : 0.25mg/0.5ml
Packaging :
Approval Date : 17/05/2000
Application Number : 20000517000016
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Orgalutran
Dosage Form : Solution For Injection
Dosage Strength : 0.25mg/5ml
Packaging :
Approval Date : 13/07/2000
Application Number : 55364
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info :
Registration Country : Moldova
Brand Name : Orgalutran®
Dosage Form : Injectable Solution
Dosage Strength : 0.25mg/0.5ml
Packaging :
Approval Date : 07-02-2019
Application Number :
Regulatory Info :
Registration Country : Moldova

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Ganirelix Orifarm
Dosage Form : Solution For Injection
Dosage Strength : 0.25mg/0.5ml
Packaging :
Approval Date : 06/10/2021
Application Number : 20200807000065
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Firefighter
Dosage Form : Solution For Injection
Dosage Strength : 0.25mg/0.5ml
Packaging :
Approval Date : 14/11/2018
Application Number : 20180316000056
Regulatory Info : Deregistered
Registration Country : Sweden

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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

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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

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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Firefighter
Dosage Form : Solution For Injection
Dosage Strength : 0.25mg/0.5ml
Packaging :
Approval Date : 30/05/2013
Application Number : 20120503000025
Regulatory Info : Approved
Registration Country : Sweden

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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 : Deregistered
Registration Country : Sweden
Brand Name : Firefighter
Dosage Form : Solution For Injection
Dosage Strength : 0.25mg/0.5ml
Packaging :
Approval Date : 03/05/2022
Application Number : 20220125000028
Regulatory Info : Deregistered
Registration Country : Sweden

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Ovamex
Dosage Form : Solution For Injection
Dosage Strength : 0.25mg/5ml
Packaging :
Approval Date : 06/02/2023
Application Number : 68792
Regulatory Info : Allowed
Registration Country : Switzerland

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Authorised
Registration Country : Malta
Brand Name : Fyremadel
Dosage Form : Solution For Injection
Dosage Strength : 0.5MG/ML
Packaging :
Approval Date : 2022-09-02
Application Number :
Regulatory Info : Authorised
Registration Country : Malta

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF