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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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01 1Dispersible Tablet
02 5Orodispersible Tablet
03 1POWDER
04 2POWDER FOR SOLUTION
05 12POWDER;ORAL
06 8Powder For Oral Solution
07 1Powder For Oral Solution Oral
08 2Powder for oral solution, solution
09 1Sapropterina 100Mg 120 Unita' Oral Use
10 1Sapropterina 100Mg 30 Joined' Oral Use
11 1Soluble Antic-Calc tablet
12 6Soluble Tablet
13 6Soluble Tablets
14 3Soluble tablet
15 1TABLET
16 6TABLET;ORAL
17 3Tablet
18 1Tablet For Oral Solution
19 11Blank
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01 6Allowed
02 8Approved
03 8Authorized
04 1Deregistered
05 4Prescription
06 18RX
07 27Blank
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01 1ARPETRAN
02 1Diterin
03 7KUVAN
04 17Kuvan
05 2REDDY-SAPROPTERIN
06 13SAPROPTERIN DIHYDROCHLORIDE
07 3SAPROPTERIN DIPHARMA
08 1SAPROPTERINA AUROBINDO
09 1Sapropterin Aurobindo
10 10Sapropterin Dipharma
11 1Sapropterin NOBEL
12 1Sapropterin Spirig HC
13 1Sapropterin Stada
14 1Sapropterin Teva
15 1Sapropterina Aurovitas
16 3Sapropterina Dipharma
17 1Sapropterina Stada
18 1Sapropterina Tarbis
19 1Sapropterina Teva
20 3The Cow
21 2ZELVYSIA
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01 11Australia
02 4Canada
03 10Italy
04 6Norway
05 8Spain
06 9Sweden
07 6Switzerland
08 18USA
Regulatory Info : RX
Registration Country : USA
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
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
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
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
Regulatory Info :
Registration Country : Italy
Brand Name : Diterin
Dosage Form : Tablet
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : RX
Registration Country : USA
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : RX
Registration Country : USA
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : RX
Registration Country : USA
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : RX
Registration Country : USA
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : RX
Registration Country : USA
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Italy
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF