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01 3Omgene Life Sciences Pvt. Ltd

02 3CYCLE PHARMACEUTICALS LTD.

03 3Cycle Pharmaceuticals

04 7Dipharma

05 4Eton Pharmaceuticals

06 4MEDUNIK CANADA

07 3Mendeli Kabs

08 2Nobel Ilac Sanayii Ve Ticaret A.S.

09 3Novitium Pharma LLC

10 27Swedish Orphan Biovitrum AB

11 4Torrent Pharmaceuticals Limited

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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

Nitisinone

Brand Name :

Dosage Form : Tablet

Dosage Strength : 2MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Omgene Company Banner

02

  • 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

Nitisinone

Brand Name :

Dosage Form : Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Omgene Company Banner

03

  • 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

Nitisinone

Brand Name :

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Omgene Company Banner

04

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : NITYR

Dosage Form : TABLET;ORAL

Dosage Strength : 2MG

Packaging :

Approval Date : 2017-07-26

Application Number : 209449

Regulatory Info : RX

Registration Country : USA

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05

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : NITYR

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2017-07-26

Application Number : 209449

Regulatory Info : RX

Registration Country : USA

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06

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : NITYR

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2017-07-26

Application Number : 209449

Regulatory Info : RX

Registration Country : USA

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07

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : NITISINONE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 2MG

Packaging :

Approval Date : 2023-05-25

Application Number : 216201

Regulatory Info : RX

Registration Country : USA

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08

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : NITISINONE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2023-05-25

Application Number : 216201

Regulatory Info : RX

Registration Country : USA

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09

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : NITISINONE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2023-05-25

Application Number : 216201

Regulatory Info : RX

Registration Country : USA

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10

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : NITISINONE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 20MG

Packaging :

Approval Date : 2023-05-25

Application Number : 216201

Regulatory Info : RX

Registration Country : USA

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11

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : NITISINONE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 2MG

Packaging :

Approval Date : 2022-05-26

Application Number : 212390

Regulatory Info : RX

Registration Country : USA

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12

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : NITISINONE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2022-05-26

Application Number : 212390

Regulatory Info : RX

Registration Country : USA

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13

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : NITISINONE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2022-05-26

Application Number : 212390

Regulatory Info : RX

Registration Country : USA

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14

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : NITISINONE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 20MG

Packaging :

Approval Date : 2023-04-27

Application Number : 212390

Regulatory Info : RX

Registration Country : USA

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15

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : NITISINONE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 2MG

Packaging :

Approval Date : 2019-08-26

Application Number : 211041

Regulatory Info : RX

Registration Country : USA

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16

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : NITISINONE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2019-08-26

Application Number : 211041

Regulatory Info : RX

Registration Country : USA

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17

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : NITISINONE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2019-08-26

Application Number : 211041

Regulatory Info : RX

Registration Country : USA

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18

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : ORFADIN

Dosage Form : CAPSULE;ORAL

Dosage Strength : 2MG

Packaging :

Approval Date : 2002-01-18

Application Number : 21232

Regulatory Info : RX

Registration Country : USA

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19

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : ORFADIN

Dosage Form : CAPSULE;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2002-01-18

Application Number : 21232

Regulatory Info : RX

Registration Country : USA

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20

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : ORFADIN

Dosage Form : CAPSULE;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2002-01-18

Application Number : 21232

Regulatory Info : RX

Registration Country : USA

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21

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : ORFADIN

Dosage Form : CAPSULE;ORAL

Dosage Strength : 20MG

Packaging :

Approval Date : 2016-06-13

Application Number : 21232

Regulatory Info : RX

Registration Country : USA

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22

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : ORFADIN

Dosage Form : SUSPENSION;ORAL

Dosage Strength : 4MG/ML

Packaging :

Approval Date : 2016-04-22

Application Number : 206356

Regulatory Info : RX

Registration Country : USA

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23

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

nitisinon

Brand Name : Orfadin

Dosage Form : KAPSEL, HÅRD

Dosage Strength : 20 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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24

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
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nitisinon

Brand Name : Orfadin

Dosage Form : KAPSEL, HÅRD

Dosage Strength : 10 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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25

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

nitisinon

Brand Name : Orfadin

Dosage Form : ORAL SUSPENSION

Dosage Strength : 4 MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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26

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

nitisinon

Brand Name : Orfadin

Dosage Form : KAPSEL, HÅRD

Dosage Strength : 2 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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27

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : NITISINONE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 2MG

Packaging :

Approval Date : 2023-01-09

Application Number : 215908

Regulatory Info : DISCN

Registration Country : USA

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28

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : NITISINONE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 5MG

Packaging :

Approval Date : 2023-01-09

Application Number : 215908

Regulatory Info : DISCN

Registration Country : USA

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29

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : NITISINONE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 10MG

Packaging :

Approval Date : 2023-01-09

Application Number : 215908

Regulatory Info : DISCN

Registration Country : USA

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30

Pharmtech & Ingredients
Not Confirmed
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Pharmtech & Ingredients
Not Confirmed

NITISINONE

Brand Name : NITISINONE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 20MG

Packaging :

Approval Date : 2023-01-09

Application Number : 215908

Regulatory Info : DISCN

Registration Country : USA

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