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 2Gedeon Richter
09 2Generic Health
10 1Labatec Pharm
11 1Lupin Ltd
12 1Meitheal Pharmaceuticals
13 1ORGANON CANADA INC.
14 2ORIFARM GROUP AS
15 5Organon
16 1Paranova Pharmaceuticals Ab
17 1Qilu Pharmaceutical
18 5Sun Pharmaceutical Industries Limited
19 1Theramex
20 1Tris Pharma Inc
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01 8INJECTABLE;INJECTION
02 5Injectable Solution
03 2Injectable Solution In Pre-Filled Syringe
04 1Pre-Filled Syringe
05 1SOLUTION
06 7Solution For Injection
07 5injection
08 4Blank
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01 3Allowed
02 4Approved
03 5Authorized
04 2Deregistered
05 1Prescription
06 8RX
07 10Blank
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01 2ARX Ganirelix
02 1Astarte
03 1FYREMADEL
04 3Firefighter
05 1Fyremadel
06 7GANIRELIX ACETATE
07 2GANIRELIX SUN
08 1Ganirelix Acetate
09 2Ganirelix Gedeon Richter
10 1Ganirelix Labatec
11 2Ganirelix Lupin
12 1Ganirelix Orifarm
13 1Ganirelix Theramex
14 1ORGALUTRAN
15 6Orgalutran
16 1Ovamex
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01 9Australia
02 1Canada
03 1India
04 5Spain
05 6Sweden
06 3Switzerland
07 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 : Authorized
Registration Country : Spain
Brand Name : Orgalutran
Dosage Form : Injectable Solution
Dosage Strength : 0.25MG
Packaging :
Approval Date : 2001-01-17
Application Number : 00130001
Regulatory Info : Authorized
Registration Country : Spain

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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 : Authorized
Registration Country : Spain
Brand Name : Fyremadel
Dosage Form : Injectable Solution
Dosage Strength : 0.25MG
Packaging :
Approval Date : 2013-12-26
Application Number : 78205
Regulatory Info : Authorized
Registration Country : Spain

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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