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    CAS-69056-38-8

    ACTIVE PHARMA INGREDIENTS

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    RELATED EXCIPIENT COMPANIES

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    01 1ZENARA

    02 3DR REDDYS

    03 3ANNORA PHARMA

    04 1AUROBINDO PHARMA

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    06 3ENDO OPERATIONS

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    ZENARA

    India
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    Specialty & Agro Chemical
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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

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    DR REDDYS

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

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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 : 2021-06-15

    Application Number : 207685

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    03

    DR REDDYS

    India
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    RLD : No

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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

    TE Code : AB

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    04

    DR REDDYS

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

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    RLD : No

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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

    RLD : No

    TE Code : AB

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    05

    BIOMARIN PHARM

    U.S.A
    Specialty & Agro Chemical
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    BIOMARIN PHARM

    U.S.A
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    RLD : Yes

    TE Code : AB

    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : KUVAN

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG

    Approval Date : 2007-12-13

    Application Number : 22181

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    06

    BIOMARIN PHARM

    U.S.A
    Specialty & Agro Chemical
    Not Confirmed
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    BIOMARIN PHARM

    U.S.A
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    RLD : Yes

    TE Code : AB

    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : KUVAN

    Dosage Form : POWDER;ORAL

    Dosage Strength : 100MG/PACKET

    Approval Date : 2013-12-19

    Application Number : 205065

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    07

    BIOMARIN PHARM

    U.S.A
    Specialty & Agro Chemical
    Not Confirmed
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    BIOMARIN PHARM

    U.S.A
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    Specialty & Agro Chemical
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    RLD : Yes

    TE Code : AB

    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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    08

    ENDO OPERATIONS

    Ireland
    Specialty & Agro Chemical
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    ENDO OPERATIONS

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    RLD : No

    TE Code : AB

    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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    09

    ENDO OPERATIONS

    Ireland
    Specialty & Agro Chemical
    Not Confirmed
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    ENDO OPERATIONS

    Ireland
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    Specialty & Agro Chemical
    Not Confirmed
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    RLD : No

    TE Code : AB

    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : POWDER;ORAL

    Dosage Strength : 100MG/PACKET

    Approval Date : 2019-08-20

    Application Number : 207207

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    10

    ENDO OPERATIONS

    Ireland
    Specialty & Agro Chemical
    Not Confirmed
    arrow

    ENDO OPERATIONS

    Ireland
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    Specialty & Agro Chemical
    Not Confirmed
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    RLD : No

    TE Code : AB

    SAPROPTERIN DIHYDROCHLORIDE

    Brand Name : SAPROPTERIN DIHYDROCHLORIDE

    Dosage Form : POWDER;ORAL

    Dosage Strength : 500MG/PACKET

    Approval Date : 2019-08-20

    Application Number : 210027

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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