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    Chemistry

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    Also known as:
    Molecular Formula
    C9H17Cl2N5O3
    Molecular Weight
    314.17  g/mol
    InChI Key
    RKSUYBCOVNCALL-NTVURLEBSA-N
    Sapropterin Hydrochloride
    1 2D Structure

    Sapropterin Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (6R)-2-amino-6-[(1R,2S)-1,2-dihydroxypropyl]-5,6,7,8-tetrahydro-1H-pteridin-4-one;dihydrochloride
    2.1.2 InChI
    InChI=1S/C9H15N5O3.2ClH/c1-3(15)6(16)4-2-11-7-5(12-4)8(17)14-9(10)13-7;;/h3-4,6,12,15-16H,2H2,1H3,(H4,10,11,13,14,17);2*1H/t3-,4+,6-;;/m0../s1
    2.1.3 InChI Key
    RKSUYBCOVNCALL-NTVURLEBSA-N
    2.1.4 Canonical SMILES
    CC(C(C1CNC2=C(N1)C(=O)N=C(N2)N)O)O.Cl.Cl
    2.1.5 Isomeric SMILES
    C[C@@H]([C@@H]([C@H]1CNC2=C(N1)C(=O)N=C(N2)N)O)O.Cl.Cl
    2.2 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 314.17 g/mol
    Molecular Formula C9H17Cl2N5O3
    Hydrogen Bond Donor Count8
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count2
    Exact Mass313.0708448 g/mol
    Monoisotopic Mass313.0708448 g/mol
    Topological Polar Surface Area132 A^2
    Heavy Atom Count19
    Formal Charge0
    Complexity405
    Isotope Atom Count0
    Defined Atom Stereocenter Count3
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3

    API Reference Price

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C.BERNASCONI 5 6830 - CHIASSO SDNF SWITZERLAND","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746124200,"product":"SAPROPTERIN API D01APIM2M9 BATCH NO.2503272 SAPROPTERIN API 40 KG MERETO 700 D01APIM2M9","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"DIPHARMA S A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"47.10","actualQuantity":"47.1","unit":"KGS","unitRateFc":"37500","totalValueFC":"1773492.2","currency":"USD","unitRateINR":"3208125","date":"02-May-2025","totalValueINR":"151102687.5","totalValueInUsd":"1773492.2","indian_port":"Madras Air","hs_no":"29335990","bill_no":"9827330","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"PIAZZA COL. 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C. Bernasconi 5 Chiasso SDNF Switzerland","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"}]
    16-Apr-2022
    18-Sep-2025
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    Drugs in Development

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    • Development Update
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    Dr. Reddy's Laboratories Announces the Launch of A Generic Version of Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg in the U.S. Market

    Details:

    The launch of Sapropterin Dihydrochloride Powder for Oral Solution, 100mg, a therapeutic equivalent generic version of Kuvan® (sapropterin dihydrochloride) Powder for Oral Solution, 100 mg, USP, is approved by the U.S. Food and Drug Administration (USFDA).


    Lead Product(s): Sapropterin Hydrochloride,Inapplicable

    Therapeutic Area: Genetic Disease Brand Name: Sapropterin Dihydrochloride-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 07, 2021

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    01

    Dr. Reddy's Laboratories

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    Lead Product(s) : Sapropterin Hydrochloride,Inapplicable

    Therapeutic Area : Genetic Disease

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Dr. Reddy's Laboratories Announces the Launch of A Generic Version of Sapropterin Dihydrochloride ...

    Details : The launch of Sapropterin Dihydrochloride Powder for Oral Solution, 100mg, a therapeutic equivalent generic version of Kuvan® (sapropterin dihydrochloride) Powder for Oral Solution, 100 mg, USP, is approved by the U.S. Food and Drug Administration (USFD...

    Product Name : Sapropterin Dihydrochloride-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    April 07, 2021

    Dr Reddy Company Banner

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    Dr. Reddy's Laboratories Announces the Launch of A Generic Version of Sapropterin Dihydrochloride Tablets for Oral Use in the U.S. Market

    Details:

    The launch of generic version of Sapropterin Dihydrochloride Tablets, for Oral Use, illustrating the commitment to bring affordable generic medicines to market for patients. Dr. Reddy’s Sapropterin Dihydrochloride Tablets, 100 mg are available in bottle count sizes of 120.


    Lead Product(s): Sapropterin Hydrochloride,Inapplicable

    Therapeutic Area: Genetic Disease Brand Name: Sapropterin Dihydrochloride-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 03, 2020

    Dr Reddy Company Banner

    02

    Dr. Reddy's Laboratories

    India
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    BioAsia
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    • fda
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Lead Product(s) : Sapropterin Hydrochloride,Inapplicable

    Therapeutic Area : Genetic Disease

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Dr. Reddy's Laboratories Announces the Launch of A Generic Version of Sapropterin Dihydrochloride ...

    Details : The launch of generic version of Sapropterin Dihydrochloride Tablets, for Oral Use, illustrating the commitment to bring affordable generic medicines to market for patients. Dr. Reddy’s Sapropterin Dihydrochloride Tablets, 100 mg are available in bottl...

    Product Name : Sapropterin Dihydrochloride-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 03, 2020

    Dr Reddy Company Banner

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    Virtual Booth

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    Relief Therapeutics, NeuroX Merge to Create MindMaze Therapeutics

    Details:

    The proposed merger involves Sapropterin Dihydrochloride to target Phenylalanine-4-hydroxylase, addressing PHENYLKETONURIA.


    Lead Product(s): Sapropterin Hydrochloride,Inapplicable

    Therapeutic Area: Genetic Disease Brand Name: RLF-OD032

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Sponsor: Relief Therapeutics | NeuroX

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Merger December 15, 2025

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    03

    MindMaze Therapeutics

    Switzerland
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    Cosmoprof
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    MindMaze Therapeutics

    Switzerland
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    Lead Product(s) : Sapropterin Hydrochloride,Inapplicable

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Relief Therapeutics | NeuroX

    Deal Size : Undisclosed

    Deal Type : Merger

    DEALS_DEV arrow-down

    Relief Therapeutics, NeuroX Merge to Create MindMaze Therapeutics

    Details : The proposed merger involves Sapropterin Dihydrochloride to target Phenylalanine-4-hydroxylase, addressing PHENYLKETONURIA.

    Product Name : RLF-OD032

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    December 15, 2025

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    Relief Therapeutics Reports Positive Results from RLF-OD032 Study

    Details:

    Sapropterin HCl, a miscellaneous product, shows promise in treating PAH, with a key focus on Phenylketonuria (PKU).


    Lead Product(s): Sapropterin Hydrochloride,Inapplicable

    Therapeutic Area: Genetic Disease Brand Name: Undisclosed

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 29, 2025

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    04

    Relief Therapeutics

    Switzerland
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    Cosmoprof
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    Relief Therapeutics

    Switzerland
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    Cosmoprof
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    Lead Product(s) : Sapropterin Hydrochloride,Inapplicable

    Therapeutic Area : Genetic Disease

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Relief Therapeutics Reports Positive Results from RLF-OD032 Study

    Details : Sapropterin HCl, a miscellaneous product, shows promise in treating PAH, with a key focus on Phenylketonuria (PKU).

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 29, 2025

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    Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects Under Fed

    Details:

    RLF-OD032 is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of unspecified medical condition.


    Lead Product(s): RLF-OD032,Sapropterin Hydrochloride

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 23, 2025

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    05

    APR Applied Pharma Research

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    Cosmoprof
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    APR Applied Pharma Research

    Switzerland
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    Lead Product(s) : RLF-OD032,Sapropterin Hydrochloride

    Therapeutic Area : Undisclosed

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects Under Fed

    Details : RLF-OD032 is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of unspecified medical condition.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    May 23, 2025

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    Relief Therapeutics Reports Positive Results from RLF-OD032 Study For Phenylketonuria

    Details:

    RLF-OD032 (sapropterin dihydrochloride) is a PAH agonist small molecule drug candidate which is being evaluated for the treatment of phenylketonuria.


    Lead Product(s): Sapropterin Hydrochloride,Inapplicable

    Therapeutic Area: Genetic Disease Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 04, 2024

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    06

    Relief Therapeutics

    Switzerland
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    Cosmoprof
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    Relief Therapeutics

    Switzerland
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    Cosmoprof
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    Lead Product(s) : Sapropterin Hydrochloride,Inapplicable

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Relief Therapeutics Reports Positive Results from RLF-OD032 Study For Phenylketonuria

    Details : RLF-OD032 (sapropterin dihydrochloride) is a PAH agonist small molecule drug candidate which is being evaluated for the treatment of phenylketonuria.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 04, 2024

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    Relief Completes Phase in RLF-OD032 Study; Topline Results Expected October 2024

    Details:

    RLF-OD032, an innovative and highly concentrated liquid formulation of sapropterin dihydrochloride, is designed to lower blood phenylalanine in adult and pediatric PKU patients.


    Lead Product(s): Sapropterin Hydrochloride,Inapplicable

    Therapeutic Area: Genetic Disease Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 18, 2024

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    07

    Relief Therapeutics

    Switzerland
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    Cosmoprof
    Not Confirmed

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    Switzerland
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    Cosmoprof
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    Lead Product(s) : Sapropterin Hydrochloride,Inapplicable

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Relief Completes Phase in RLF-OD032 Study; Topline Results Expected October 2024

    Details : RLF-OD032, an innovative and highly concentrated liquid formulation of sapropterin dihydrochloride, is designed to lower blood phenylalanine in adult and pediatric PKU patients.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    September 18, 2024

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    Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects

    Details:

    RLF-OD032 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


    Lead Product(s): RLF-OD032,Sapropterin Hydrochloride

    Therapeutic Area: Undisclosed Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 01, 2024

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    08

    APR Applied Pharma Research

    Switzerland
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    Cosmoprof
    Not Confirmed

    APR Applied Pharma Research

    Switzerland
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    Cosmoprof
    Not Confirmed
    • fda
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    Lead Product(s) : RLF-OD032,Sapropterin Hydrochloride

    Therapeutic Area : Undisclosed

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Study on Sapropterin Dihydrochloride Oral Suspension in Healthy Subjects

    Details : RLF-OD032 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    July 01, 2024

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    PD-1 Antibody and Sapropterin Dihydrochloride in Patients With PDAC

    Details:

    Sapropterin Dihydrochloride is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Pancreatic Neoplasms.


    Lead Product(s): Sapropterin Hydrochloride,Inapplicable

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Miscellaneous

    Sponsor: Innovent Biologics

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 02, 2024

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    09

    Sun Yat-sen University

    Country
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    Sun Yat-sen University

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    Lead Product(s) : Sapropterin Hydrochloride,Inapplicable

    Therapeutic Area : Oncology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Innovent Biologics

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    PD-1 Antibody and Sapropterin Dihydrochloride in Patients With PDAC

    Details : Sapropterin Dihydrochloride is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Pancreatic Neoplasms.

    Product Name : Undisclosed

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    Upfront Cash : Inapplicable

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    The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudication

    Details:

    Tetrahydrobiopterin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Intermittent Claudication.


    Lead Product(s): Sapropterin Hydrochloride,Ascorbic Acid,L-Arginine

    Therapeutic Area: Musculoskeletal Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Louis Messina

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 16, 2021

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    BioMarin Pharmaceutical

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    Lead Product(s) : Sapropterin Hydrochloride,Ascorbic Acid,L-Arginine

    Therapeutic Area : Musculoskeletal

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Louis Messina

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    The Effects of ATLAS Therapy on Nitric Oxide Bioavailability in Patients With Intermittent Claudic...

    Details : Tetrahydrobiopterin is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Intermittent Claudication.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    March 16, 2021

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    ZENARA

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    RLD : No

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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

    Approval Date : 2025-06-11

    Application Number : 218797

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

    Biophore CB

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    DR REDDYS

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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

    Approval Date : 2021-06-15

    Application Number : 207685

    RX/OTC/DISCN : RX

    RLD : No

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    DR REDDYS

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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : POWDER;ORAL

    Dosage Strength : 100MG/PACKET

    Approval Date : 2021-03-30

    Application Number : 209452

    RX/OTC/DISCN : RX

    RLD : No

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    DR REDDYS

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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : POWDER;ORAL

    Dosage Strength : 500MG/PACKET

    Approval Date : 2022-05-13

    Application Number : 215798

    RX/OTC/DISCN : RX

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    AUCTA

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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : ZELVYSIA

    Dosage Form : POWDER;ORAL

    Dosage Strength : 100MG/PACKET

    Approval Date : 2025-04-29

    Application Number : 218645

    RX/OTC/DISCN : RX

    RLD : No

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    Brand Name : ZELVYSIA

    Dosage Form : POWDER;ORAL

    Dosage Strength : 500MG/PACKET

    Approval Date : 2025-04-29

    Application Number : 218645

    RX/OTC/DISCN : RX

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    AUROBINDO PHARMA

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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

    Approval Date : 2025-06-09

    Application Number : 216797

    RX/OTC/DISCN : RX

    RLD : No

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    BIOMARIN PHARM

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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : KUVAN

    Dosage Form : POWDER;ORAL

    Dosage Strength : 500MG/PACKET

    Approval Date : 2015-10-27

    Application Number : 205065

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    PH HEALTH

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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

    Approval Date : 2019-05-10

    Application Number : 207200

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : POWDER;ORAL

    Dosage Strength : 100MG/PACKET

    Approval Date : 2025-09-03

    Application Number : 216432

    RX/OTC/DISCN : RX

    RLD : No

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    ABOUT THIS PAGE

    Looking for / Sapropterin Hydrochloride API manufacturers, exporters & distributors?

    Sapropterin Hydrochloride manufacturers, exporters & distributors 1

    48

    PharmaCompass offers a list of Sapropterin Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Sapropterin Hydrochloride manufacturer or Sapropterin Hydrochloride supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sapropterin Hydrochloride manufacturer or Sapropterin Hydrochloride supplier.

    PharmaCompass also assists you with knowing the Sapropterin Hydrochloride API Price utilized in the formulation of products. Sapropterin Hydrochloride API Price is not always fixed or binding as the Sapropterin Hydrochloride Price is obtained through a variety of data sources. The Sapropterin Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Sapropterin Hydrochloride

    Sapropterin Hydrochloride Manufacturers

    A Sapropterin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sapropterin Hydrochloride, including repackagers and relabelers. The FDA regulates Sapropterin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sapropterin Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Sapropterin Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Sapropterin Hydrochloride Suppliers

    A Sapropterin Hydrochloride supplier is an individual or a company that provides Sapropterin Hydrochloride active pharmaceutical ingredient (API) or Sapropterin Hydrochloride finished formulations upon request. The Sapropterin Hydrochloride suppliers may include Sapropterin Hydrochloride API manufacturers, exporters, distributors and traders.

    click here to find a list of Sapropterin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Sapropterin Hydrochloride USDMF

    A Sapropterin Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Sapropterin Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Sapropterin Hydrochloride DMFs exist exist since differing nations have different regulations, such as Sapropterin Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Sapropterin Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Sapropterin Hydrochloride USDMF includes data on Sapropterin Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sapropterin Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Sapropterin Hydrochloride suppliers with USDMF on PharmaCompass.

    Sapropterin Hydrochloride WC

    A Sapropterin Hydrochloride written confirmation (Sapropterin Hydrochloride WC) is an official document issued by a regulatory agency to a Sapropterin Hydrochloride manufacturer, verifying that the manufacturing facility of a Sapropterin Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sapropterin Hydrochloride APIs or Sapropterin Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Sapropterin Hydrochloride WC (written confirmation) as part of the regulatory process.

    click here to find a list of Sapropterin Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

    Sapropterin Hydrochloride NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Sapropterin Hydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Sapropterin Hydrochloride API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Sapropterin Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Sapropterin Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sapropterin Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Sapropterin Hydrochloride suppliers with NDC on PharmaCompass.

    Sapropterin Hydrochloride GMP

    Sapropterin Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Sapropterin Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Sapropterin Hydrochloride GMP manufacturer or Sapropterin Hydrochloride GMP API supplier for your needs.

    Sapropterin Hydrochloride CoA

    A Sapropterin Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Sapropterin Hydrochloride's compliance with Sapropterin Hydrochloride specifications and serves as a tool for batch-level quality control.

    Sapropterin Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Sapropterin Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Sapropterin Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Sapropterin Hydrochloride EP), Sapropterin Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sapropterin Hydrochloride USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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