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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

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PharmaCompass

01

  • 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

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 : 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

03

  • 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

04

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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

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05

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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

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06

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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

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07

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
Not Confirmed

Sapropterin

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

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08

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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

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09

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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

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10

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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

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11

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
Not Confirmed

sapropterin dihydrochloride

Brand Name : Kuvan

Dosage Form : SOLUBLE TABLET

Dosage Strength : 100 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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12

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
Not Confirmed

Sapropterin Dihydrochloride

Brand Name : Kuvan

Dosage Form : Soluble Antic-Calc tablet

Dosage Strength : 100 mg

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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13

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
Not Confirmed

Sapropterin

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

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14

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
Not Confirmed

Sapropterin

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

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15

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
Not Confirmed

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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16

ENDO OPERATIONS

Country
2024 ACI Convention
Not Confirmed
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ENDO OPERATIONS

Country
arrow
2024 ACI Convention
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

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17

ENDO OPERATIONS

Country
2024 ACI Convention
Not Confirmed
arrow

ENDO OPERATIONS

Country
arrow
2024 ACI Convention
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

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18

ENDO OPERATIONS

Country
2024 ACI Convention
Not Confirmed
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ENDO OPERATIONS

Country
arrow
2024 ACI Convention
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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19

Country
2024 ACI Convention
Not Confirmed
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Country
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2024 ACI Convention
Not Confirmed

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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20

Country
2024 ACI Convention
Not Confirmed
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Country
arrow
2024 ACI Convention
Not Confirmed

Tetrahydrobiopterin

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

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