DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 3Dr. Reddy's Laboratories
02 3Annora Pharma
03 1Aurobindo Pharma Limited
04 21BioMarin Pharmaceutical
05 2DR REDDY'S LABORATORIES LTD
06 8Dipharma
07 4Dipharma SA
08 3ENDO OPERATIONS
09 1ORIFARM GROUP AS
10 1PIAM Farmaceutici S.p.A
11 2Blank
01 2Disp Tabl
02 2POWDER
03 2POWDER FOR SOLUTION
04 8POWDER;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 4TABLET;ORAL
16 1Tablet
17 11Blank
01 5Prescription
02 12RX
03 32Blank
01 1ARPETRAN
02 1Diterin
03 8KUVAN
04 16Kuvan
05 2REDDY-SAPROPTERIN
06 9SAPROPTERIN DIHYDROCHLORIDE
07 3SAPROPTERIN DIPHARMA
08 1SAPROPTERINA AUROBINDO
09 8Sapropterin Dipharma
01 11Australia
02 5Canada
03 10Italy
04 6Norway
05 1Sweden
06 4Switzerland
07 12USA
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 :
Registration Country : Italy
Brand Name : SAPROPTERINA AUROBINDO
Dosage Form : Soluble Tablets
Dosage Strength : 100 mg
Packaging : 120 UNITS 100 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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 : Norway
Brand Name : Kuvan
Dosage Form : Soluble Antic-Calc tablet
Dosage Strength : 100 mg
Packaging : Bottle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Italy
Brand Name : KUVAN
Dosage Form : Soluble Tablets
Dosage Strength : 100mg
Packaging : 120 UNITS 100 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : KUVAN
Dosage Form : Soluble Tablets
Dosage Strength : 100mg
Packaging : 30 UNITS 100 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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 :
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
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