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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Embio Limited

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    01 (+)-Ephedrine Hydrochloride (1)

    02 Buprenorphine (1)

    03 Cannabidiol (1)

    04 Dl-Methylephedrine Hydrochloride (1)

    05 Ephedrine Hydrochloride (1)

    06 Ephedrine Sulfate (2)

    07 Lisdexamfetamine Dimesylate (1)

    08 Menthadienol (1)

    09 Methadone Hydrochloride (1)

    10 Methylephedrine (1)

    11 Norpseudoephedrine Hydrochloride (1)

    12 Octopamine Hydrochloride (1)

    13 Olivetol (1)

    14 Oxyfedrine Hydrochloride (1)

    15 Phenylpropanolamine (1)

    16 Pseudoephedrine (1)

    17 Pseudoephedrine Hydrochloride (1)

    18 Pseudoephedrine Sulfate (1)

    19 Pseudoephedrine, Hydrochloride, (-)- (1)

    20 Selegiline Hydrochloride (1)

    21 d-Norpseudoephedrine hydrochloride (2)

    filter

    01 Active (4)

    02 Inactive (2)

    03 Blank (17)

    filter

    01 Valid (2)

    02 Blank (21)

    filter

    01 220MF10147 (1)

    02 230MF10091 (1)

    03 Blank (21)

    filter

    01 WC-0046 (10)

    02 WC-0046-Anexure (2)

    03 Blank (11)

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    • FDA
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    Pseudoephedrine Hydrochloride

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    USDMF

    Found USDMF

    13948
    Active
    PSEUDOEPHEDRINE HYDROCHLORIDE, USP
    1998-12-29
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-143 - Rev 02
    Valid
    Pseudoephedrine hydrochloride
    2009-10-05
    Japanese DMF

    Found JDMF

    230MF10091
    Pseudoephedrine Hydrochloride at 50...
    2018-07-26
    Written Confirmation

    Found WC

    Indian CDSCO WC-0046
    Valid
    Pseudoephedrine HCl IP/BP/EP/USP/JP...
    2022-09-01
    Application Number
    13948
    R1-CEP 1999-143 - Rev 02
    230MF10091
    Indian CDSCO WC-0046
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-28
    Filing Details
    PSEUDOEPHEDRINE HYDROCHLORIDE, USP
    Pseudoephedrine hydrochloride
    Pseudoephedrine Hydrochloride at 50...
    Pseudoephedrine HCl IP/BP/EP/USP/JP...
    Issue/Submission Date
    1998-12-29
    2009-10-05
    2018-07-26
    2022-09-01
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    • FDA
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    Ephedrine Hydrochloride

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    USDMF

    Caution USDMF

    9278
    Inactive
    EPHEDRINE HYDROCHLORIDE USP
    1991-08-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    220MF10147
    Japanese Pharmacopoeia ephedrine hy...
    2008-06-10
    Written Confirmation

    Found WC

    Indian CDSCO WC-0046
    Valid
    Ephedrine Hydrochloride IP/BP/EP/US...
    2022-09-01
    Application Number
    9278
    220MF10147
    Indian CDSCO WC-0046
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-07-28
    Filing Details
    EPHEDRINE HYDROCHLORIDE USP
    Japanese Pharmacopoeia ephedrine hy...
    Ephedrine Hydrochloride IP/BP/EP/US...
    Issue/Submission Date
    1991-08-09
    2008-06-10
    2022-09-01
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    Cannabidiol

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    USDMF

    Found USDMF

    38286
    Active
    CANNABIDIOL-SYNTHETIC
    2023-05-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0046
    Valid
    Cannabidiol-Synthetic INH
    2022-09-01
    Application Number
    38286
    Indian CDSCO WC-0046
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-07-28
    Filing Details
    CANNABIDIOL-SYNTHETIC
    Cannabidiol-Synthetic INH
    Issue/Submission Date
    2023-05-11
    2022-09-01
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    Methadone Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2020-306 - Rev 00
    Valid
    Methadone hydrochloride
    2022-05-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0046
    Valid
    Methadone Hydrochloride IP/BP/EP/US...
    2022-09-01
    Application Number
    R0-CEP 2020-306 - Rev 00
    Indian CDSCO WC-0046
    Status
    Valid
     
    Valid
    2025-07-28
    Filing Details
    Methadone hydrochloride
    Methadone Hydrochloride IP/BP/EP/US...
    Issue/Submission Date
    2022-05-06
    2022-09-01
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    Pseudoephedrine Sulfate

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    USDMF

    Found USDMF

    35861
    Active
    PSEUDOEPHEDRINE SULFATE USP
    2021-05-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0046
    Valid
    Pseudoephedrine Sulphate USP
    2022-09-01
    Application Number
    35861
    Indian CDSCO WC-0046
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-28
    Filing Details
    PSEUDOEPHEDRINE SULFATE USP
    Pseudoephedrine Sulphate USP
    Issue/Submission Date
    2021-05-23
    2022-09-01
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    Ephedrine Sulfate

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    USDMF

    Caution USDMF

    14698
    Inactive
    PSEUDOEPHEDRINE SULFATE USP
    2000-01-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0046
    Valid
    Ephedrine Sulfate USP
    2022-09-01
    Application Number
    14698
    Indian CDSCO WC-0046
    Status
    Inactive
    Fees Paid
    N/A
     
    Valid
    2025-07-28
    Filing Details
    PSEUDOEPHEDRINE SULFATE USP
    Ephedrine Sulfate USP
    Issue/Submission Date
    2000-01-31
    2022-09-01
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    • FDA
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    Dl-Methylephedrine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0046
    Valid
    Di-Methylephedrine Hydrochloride (J...
    2022-09-01
    Application Number
    Indian CDSCO WC-0046
    Status
     
    Valid
    2025-07-28
    Filing Details
    Di-Methylephedrine Hydrochloride (J...
    Issue/Submission Date
    2022-09-01
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    Ephedrine Sulfate

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    USDMF

    Found USDMF

    32697
    Active
    EPHEDRINE SULFATE USP
    2018-04-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32697
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    EPHEDRINE SULFATE USP
    Issue/Submission Date
    2018-04-17
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    Lisdexamfetamine Dimesylate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0046
    Valid
    Lisdexamphetamine dimesilate INH
    2022-09-01
    Application Number
    Indian CDSCO WC-0046
    Status
     
    Valid
    2025-07-28
    Filing Details
    Lisdexamphetamine dimesilate INH
    Issue/Submission Date
    2022-09-01
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    Phenylpropanolamine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0046
    Valid
    Di-Norpseudoephedrine IH
    2022-09-01
    Application Number
    Indian CDSCO WC-0046
    Status
     
    Valid
    2025-07-28
    Filing Details
    Di-Norpseudoephedrine IH
    Issue/Submission Date
    2022-09-01
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