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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 24BioMarin Pharmaceutical

08 6Biomarin International Limited

09 20Dipharma

10 3Dipharma SA

11 1Drac Ag

12 2Micro Labs Limited

13 1Nobel Pharma Schweiz Ag

14 3PH HEALTH

15 1PIAM Farmaceutici S.p.A

16 3STADA Arzneimittel

17 1Sandoz B2B

18 1Spirig Healthcare

19 1Tarbis Farma Sl

20 3Teva Pharmaceutical Industries

21 2Tulex Pharmaceutical

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

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

blank

08

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

blank

10

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

blank

12

ASPEN
Not Confirmed
arrow
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ASPEN
Not Confirmed

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

blank

13

ASPEN
Not Confirmed
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ASPEN
Not Confirmed

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

blank

14

ASPEN
Not Confirmed
arrow
arrow
ASPEN
Not Confirmed

SAPROPTERIN DIHYDROCHLORIDE

Brand Name : SAPROPTERIN DIHYDROCHLORIDE

Dosage Form : POWDER;ORAL

Dosage Strength : 100MG/PACKET

Packaging :

Approval Date :

Application Number : 219511

Regulatory Info :

Registration Country : USA

blank

15

ASPEN
Not Confirmed
arrow
arrow
ASPEN
Not Confirmed

SAPROPTERIN DIHYDROCHLORIDE

Brand Name : SAPROPTERIN DIHYDROCHLORIDE

Dosage Form : POWDER;ORAL

Dosage Strength : 500MG/PACKET

Packaging :

Approval Date :

Application Number : 219511

Regulatory Info :

Registration Country : USA

blank

16

ASPEN
Not Confirmed
arrow
arrow
ASPEN
Not Confirmed

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

blank

17

ASPEN
Not Confirmed
arrow
arrow
ASPEN
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

18

PH HEALTH

Country
ASPEN
Not Confirmed
arrow

PH HEALTH

Country
arrow
ASPEN
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

19

PH HEALTH

Country
ASPEN
Not Confirmed
arrow

PH HEALTH

Country
arrow
ASPEN
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

20

PH HEALTH

Country
ASPEN
Not Confirmed
arrow

PH HEALTH

Country
arrow
ASPEN
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

blank