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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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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

Regulatory Info :

Registration Country : India

Ganirelix

Brand Name : Ganirelix Acetate

Dosage Form : Pre-Filled Syringe

Dosage Strength : 250MCG/0.5ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Omgene Company Banner

02

SCOPE Summit
Not Confirmed
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GANIRELIX ACETATE

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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03

SCOPE Summit
Not Confirmed
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SCOPE Summit
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Ganirelix Acetate

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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04

SCOPE Summit
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SCOPE Summit
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GANIRELIX ACETATE

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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05

SCOPE Summit
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Left Behind

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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06

GANIRELIX ACETATE

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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07

SCOPE Summit
Not Confirmed
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SCOPE Summit
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GANIRELIX ACETATE

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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08

SCOPE Summit
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GANIRELIX ACETATE

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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09

SCOPE Summit
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Ganirelix

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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10

SCOPE Summit
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Left Behind

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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11

SCOPE Summit
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Ganirelix

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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12

SCOPE Summit
Not Confirmed
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Ganirelix Acetate

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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13

SCOPE Summit
Not Confirmed
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Ganirelix Acetate

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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14

SCOPE Summit
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GANIRELIX ACETATE

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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15

SCOPE Summit
Not Confirmed
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GANIRELIX ACETATE

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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16

SCOPE Summit
Not Confirmed
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SCOPE Summit
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Ganirelix Acetate

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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17

SCOPE Summit
Not Confirmed
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SCOPE Summit
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GANIRELIX ACETATE

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

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18

Paranova Pharmaceuticals Ab

Country
SCOPE Summit
Not Confirmed
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Paranova Pharmaceuticals Ab

Country
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SCOPE Summit
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Ganirelix Acetate

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

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19

Future Health Pharma Gmbh

Country
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Future Health Pharma Gmbh

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Left Behind

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

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20

JV Healthcare Limited

Country
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JV Healthcare Limited

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Ganirelix

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

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