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01 3Omgene Life Sciences Pvt. Ltd

02 5Cycle Pharmaceuticals

03 15Dipharma

04 4Eton Pharmaceuticals

05 4MEDUNIK CANADA

06 10Mendeli Kabs

07 2Nobel Ilac Sanayii Ve Ticaret A.S.

08 3Novitium Pharma LLC

09 32Swedish Orphan Biovitrum AB

10 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 : Nitisinone

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 : Nitisinone

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 : Nitisinone

Dosage Form : Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

Omgene Company Banner

04

Biotech Showcase
Not Confirmed
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Biotech Showcase
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

Biotech Showcase
Not Confirmed
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Biotech Showcase
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

Biotech Showcase
Not Confirmed
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Biotech Showcase
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

Biotech Showcase
Not Confirmed
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Biotech Showcase
Not Confirmed

NITISINONE

Brand Name : HARLIKU

Dosage Form : TABLET;ORAL

Dosage Strength : 2MG

Packaging :

Approval Date : 2025-06-10

Application Number : 209449

Regulatory Info : RX

Registration Country : USA

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08

Biotech Showcase
Not Confirmed
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Biotech Showcase
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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09

Biotech Showcase
Not Confirmed
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Biotech Showcase
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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10

Biotech Showcase
Not Confirmed
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Biotech Showcase
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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11

Biotech Showcase
Not Confirmed
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Biotech Showcase
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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12

Biotech Showcase
Not Confirmed
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Biotech Showcase
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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13

Biotech Showcase
Not Confirmed
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Biotech Showcase
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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14

Biotech Showcase
Not Confirmed
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Biotech Showcase
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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15

Biotech Showcase
Not Confirmed
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Biotech Showcase
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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16

Biotech Showcase
Not Confirmed
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Biotech Showcase
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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17

Biotech Showcase
Not Confirmed
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Biotech Showcase
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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18

Biotech Showcase
Not Confirmed
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Biotech Showcase
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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19

Biotech Showcase
Not Confirmed
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Biotech Showcase
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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20

Biotech Showcase
Not Confirmed
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Biotech Showcase
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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