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01 1Zenara Pharma

02 3Dr. Reddy's Laboratories

03 2Aucta Pharmaceuticals

04 3Annora Pharma

05 3Aurobindo Pharma Limited

06 1Aurovitas Spain, Sau

07 20BioMarin Pharmaceutical

08 3Biomarin International Limited

09 2DR REDDY'S LABORATORIES LTD

10 14Dipharma

11 3Dipharma SA

12 1Drac Ag

13 2HOPEWELL PHARMA

14 1Nobel Pharma Schweiz Ag

15 1ORIFARM GROUP AS

16 3PH HEALTH

17 1PIAM Farmaceutici S.p.A

18 2STADA Arzneimittel

19 1Spirig Healthcare

20 1Tarbis Farma Sl

21 2Teva Pharmaceutical Industries

22 2Blank

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PharmaCompass

01

SAPROPTERIN DIHYDROCHLORIDE

Brand Name : SAPROPTERIN DIHYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date : 2025-06-11

Application Number : 218797

Regulatory Info : RX

Registration Country : USA

Biophore CB

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : RX

Registration Country : USA

SAPROPTERIN DIHYDROCHLORIDE

Brand Name : SAPROPTERIN DIHYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date : 2021-06-15

Application Number : 207685

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAucta is a global brand that creates better products from proven molecules.

Regulatory Info : RX

Registration Country : USA

SAPROPTERIN DIHYDROCHLORIDE

Brand Name : ZELVYSIA

Dosage Form : POWDER;ORAL

Dosage Strength : 100MG/PACKET

Packaging :

Approval Date : 2025-04-29

Application Number : 218645

Regulatory Info : RX

Registration Country : USA

Aucta Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : RX

Registration Country : USA

SAPROPTERIN DIHYDROCHLORIDE

Brand Name : SAPROPTERIN DIHYDROCHLORIDE

Dosage Form : POWDER;ORAL

Dosage Strength : 100MG/PACKET

Packaging :

Approval Date : 2021-03-30

Application Number : 209452

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Regulatory Info : RX

Registration Country : USA

SAPROPTERIN DIHYDROCHLORIDE

Brand Name : SAPROPTERIN DIHYDROCHLORIDE

Dosage Form : POWDER;ORAL

Dosage Strength : 500MG/PACKET

Packaging :

Approval Date : 2022-05-13

Application Number : 215798

Regulatory Info : RX

Registration Country : USA

Dr Reddy Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAucta is a global brand that creates better products from proven molecules.

Regulatory Info : RX

Registration Country : USA

SAPROPTERIN DIHYDROCHLORIDE

Brand Name : ZELVYSIA

Dosage Form : POWDER;ORAL

Dosage Strength : 500MG/PACKET

Packaging :

Approval Date : 2025-04-29

Application Number : 218645

Regulatory Info : RX

Registration Country : USA

Aucta Company Banner

07

The Battery Show
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SAPROPTERIN DIHYDROCHLORIDE

Brand Name : SAPROPTERIN DIHYDROCHLORIDE

Dosage Form : POWDER;ORAL

Dosage Strength : 100MG/PACKET

Packaging :

Approval Date : 2022-08-18

Application Number : 215420

Regulatory Info : RX

Registration Country : USA

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08

The Battery Show
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The Battery Show
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SAPROPTERIN DIHYDROCHLORIDE

Brand Name : SAPROPTERIN DIHYDROCHLORIDE

Dosage Form : POWDER;ORAL

Dosage Strength : 500MG/PACKET

Packaging :

Approval Date : 2022-08-18

Application Number : 215420

Regulatory Info : RX

Registration Country : USA

blank

09

The Battery Show
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SAPROPTERIN DIHYDROCHLORIDE

Brand Name : SAPROPTERIN DIHYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date : 2022-08-23

Application Number : 215534

Regulatory Info : RX

Registration Country : USA

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10

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SAPROPTERIN DIHYDROCHLORIDE

Brand Name : SAPROPTERIN DIHYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date : 2025-06-09

Application Number : 216797

Regulatory Info : RX

Registration Country : USA

blank

11

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SAPROPTERIN DIHYDROCHLORIDE

Brand Name : KUVAN

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date : 2007-12-13

Application Number : 22181

Regulatory Info : RX

Registration Country : USA

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12

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SAPROPTERIN DIHYDROCHLORIDE

Brand Name : KUVAN

Dosage Form : POWDER;ORAL

Dosage Strength : 100MG/PACKET

Packaging :

Approval Date : 2013-12-19

Application Number : 205065

Regulatory Info : RX

Registration Country : USA

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13

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SAPROPTERIN DIHYDROCHLORIDE

Brand Name : KUVAN

Dosage Form : POWDER;ORAL

Dosage Strength : 500MG/PACKET

Packaging :

Approval Date : 2015-10-27

Application Number : 205065

Regulatory Info : RX

Registration Country : USA

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14

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sapropterin 2HCl

Brand Name : Diterin

Dosage Form : Tablet

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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15

PH HEALTH

Country
The Battery Show
Not Confirmed
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PH HEALTH

Country
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The Battery Show
Not Confirmed

SAPROPTERIN DIHYDROCHLORIDE

Brand Name : SAPROPTERIN DIHYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Packaging :

Approval Date : 2019-05-10

Application Number : 207200

Regulatory Info : RX

Registration Country : USA

blank

16

PH HEALTH

Country
The Battery Show
Not Confirmed
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PH HEALTH

Country
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Not Confirmed

SAPROPTERIN DIHYDROCHLORIDE

Brand Name : SAPROPTERIN DIHYDROCHLORIDE

Dosage Form : POWDER;ORAL

Dosage Strength : 100MG/PACKET

Packaging :

Approval Date : 2019-08-20

Application Number : 207207

Regulatory Info : RX

Registration Country : USA

blank

17

PH HEALTH

Country
The Battery Show
Not Confirmed
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PH HEALTH

Country
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The Battery Show
Not Confirmed

SAPROPTERIN DIHYDROCHLORIDE

Brand Name : SAPROPTERIN DIHYDROCHLORIDE

Dosage Form : POWDER;ORAL

Dosage Strength : 500MG/PACKET

Packaging :

Approval Date : 2019-08-20

Application Number : 210027

Regulatory Info : RX

Registration Country : USA

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18

HOPEWELL PHARMA

Country
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HOPEWELL PHARMA

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SAPROPTERIN DIHYDROCHLORIDE

Brand Name : SAPROPTERIN DIHYDROCHLORIDE

Dosage Form : POWDER;ORAL

Dosage Strength : 100MG/PACKET

Packaging :

Approval Date : 2025-09-03

Application Number : 216432

Regulatory Info : RX

Registration Country : USA

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19

HOPEWELL PHARMA

Country
The Battery Show
Not Confirmed
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HOPEWELL PHARMA

Country
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The Battery Show
Not Confirmed

SAPROPTERIN DIHYDROCHLORIDE

Brand Name : SAPROPTERIN DIHYDROCHLORIDE

Dosage Form : POWDER;ORAL

Dosage Strength : 500MG/PACKET

Packaging :

Approval Date : 2025-09-03

Application Number : 216432

Regulatory Info : RX

Registration Country : USA

blank

20

Country
The Battery Show
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Tetrahydrobiopterin

Brand Name : Kuvan

Dosage Form : Sapropterina 100Mg 120 Unita' Oral Use

Dosage Strength : 120 cpr solub 100 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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