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01 1Zenara Pharma
02 3Dr. Reddy's Laboratories
03 3Annora Pharma
04 2Aurobindo Pharma Limited
05 21BioMarin Pharmaceutical
06 2DR REDDY'S LABORATORIES LTD
07 8Dipharma
08 4Dipharma SA
09 3Endo International
10 1ORIFARM GROUP AS
11 1PIAM Farmaceutici S.p.A
12 2SHANGHAI AUCYUN
13 2Blank
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01 2Disp Tabl
02 2POWDER
03 2POWDER FOR SOLUTION
04 10POWDER;ORAL
05 2Plv
06 1Powder For Oral Solution Oral
07 2Powder for oral solution, solution
08 1SOLUBLE TABLET
09 1Sapropterina 100Mg 120 Unita' Oral Use
10 1Sapropterina 100Mg 30 Joined' Oral Use
11 1Soluble Antic-Calc tablet
12 6Soluble Tablets
13 3Soluble tablet
14 1TABLET
15 6TABLET;ORAL
16 1Tablet
17 11Blank
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01 16RX
02 37Blank
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01 1ARPETRAN
02 1Diterin
03 8KUVAN
04 16Kuvan
05 2REDDY-SAPROPTERIN
06 11SAPROPTERIN DIHYDROCHLORIDE
07 3SAPROPTERIN DIPHARMA
08 1SAPROPTERINA AUROBINDO
09 8Sapropterin Dipharma
10 2ZELVYSIA
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01 11Australia
02 5Canada
03 10Italy
04 6Norway
05 1Sweden
06 4Switzerland
07 16USA
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
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 : 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 : Sweden
Brand Name : Kuvan
Dosage Form : SOLUBLE TABLET
Dosage Strength : 100 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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
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
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
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
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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
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
Regulatory Info :
Registration Country : Italy
Brand Name : Kuvan
Dosage Form : Sapropterina 100Mg 30 Joined' Oral Use
Dosage Strength : 30 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