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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Morepen Laboratories

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    01 Abemaciclib (1)

    02 Apixaban (3)

    03 Atorvastatin (3)

    04 Axitinib (1)

    05 Baricitinib (1)

    06 Bempedoic Acid (1)

    07 Bilastine (1)

    08 Brexpiprazole (1)

    09 Candesartan Cilexetil (1)

    10 Cariprazine Hydrochloride (1)

    11 Cladribine (1)

    12 Dapagliflozin (1)

    13 Dapagliflozin Propanediol Monohydrate (1)

    14 Desloratadine (1)

    15 Edoxaban Tosylate (1)

    16 Empagliflozin (1)

    17 Enzalutamide (1)

    18 Ertugliflozin (1)

    19 Fexofenadine Hydrochloride (1)

    20 Finerenone (1)

    21 Ibrutinib (1)

    22 Imeglimin Hydrochloride (1)

    23 Linagliptin (2)

    24 Loratadine (2)

    25 Macitentan (1)

    26 Mavacamten (1)

    27 Montelukast Sodium (2)

    28 Nintedanib Esylate (1)

    29 Olaparib (1)

    30 Olmesartan Medoxomil (1)

    31 Palbociclib (1)

    32 Paliperidone Palmitate (1)

    33 Pioglitazone Hydrochloride (1)

    34 Rivaroxaban (2)

    35 Rosuvastatin Calcium (2)

    36 Saxagliptin Hydrochloride (2)

    37 Sitagliptin Phosphate (2)

    38 Tafamidis (1)

    39 Tafamidis Meglumine (1)

    40 Ticagrelor (1)

    41 Tofacitinib Citrate (1)

    42 Trelagliptin Succinate (1)

    43 Upadacitinib (1)

    44 Vericiguat (1)

    45 Vonoprazan Fumarate (1)

    46 Vortioxetine Hydrobromide (1)

    filter

    01 Active (26)

    02 Inactive (3)

    03 Blank (28)

    filter

    01 Valid (9)

    02 Blank (48)

    filter

    01 227MF10263 (1)

    02 302MF10070 (1)

    03 Blank (55)

    filter

    01 WC-0050 (7)

    02 WC-0050A (1)

    03 WC-0050A2 (2)

    04 WC-0050A4 (3)

    05 WC-0050a3 (2)

    06 WC-0060 (3)

    07 Blank (39)

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    Loratadine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    12650
    Active
    LORATADINE
    1997-09-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-348 - Rev 04
    Valid
    Loratadine, Milled, micronised
    2023-06-13
    Japanese DMF

    Found JDMF

    227MF10263
    Loratadine at 2nd Floor, Tower C, D...
    2015-11-11
    Written Confirmation

    Found WC

    Indian CDSCO WC-0060
    Valid
    Loratadine EP/USP
    2022-06-03
    Application Number
    12650
    R1-CEP 2007-348 - Rev 04
    227MF10263
    Indian CDSCO WC-0060
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    LORATADINE
    Loratadine, Milled, micronised
    Loratadine at 2nd Floor, Tower C, D...
    Loratadine EP/USP
    Issue/Submission Date
    1997-09-11
    2023-06-13
    2015-11-11
    2022-06-03
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    Atorvastatin

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    18122
    Inactive
    ATORVASTATIN CALCIUM
    2005-02-23
    CEP/COS

    Found CEP/COS

    CEP 2012-179 - Rev 04
    Valid
    Atorvastatin calcium, Micronised
    2023-09-18
    Japanese DMF

    Found JDMF

    302MF10070
    Atorvastatin calcium hydrate at 4th...
    2020-06-23
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0050
    Expired
    Atorvastatin Calcium Trihydrate EP/...
    2019-06-17
    Application Number
    18122
    CEP 2012-179 - Rev 04
    302MF10070
    Indian CDSCO WC-0050
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-06-16
    Filing Details
    ATORVASTATIN CALCIUM
    Atorvastatin calcium, Micronised
    Atorvastatin calcium hydrate at 4th...
    Atorvastatin Calcium Trihydrate EP/...
    Issue/Submission Date
    2005-02-23
    2023-09-18
    2020-06-23
    2019-06-17
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    Desloratadine

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    USDMF

    Found USDMF

    17652
    Active
    DESLORATADINE
    2004-09-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-302 - Rev 00
    Valid
    Desloratadine, Milled, micronised
    2020-10-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0060
    Valid
    Desloratidine USP/EP
    2022-06-03
    Application Number
    17652
    R1-CEP 2014-302 - Rev 00
    Indian CDSCO WC-0060
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    DESLORATADINE
    Desloratadine, Milled, micronised
    Desloratidine USP/EP
    Issue/Submission Date
    2004-09-07
    2020-10-19
    2022-06-03
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    Montelukast Sodium

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    USDMF

    Found USDMF

    24445
    Active
    MONTELUKAST SODIUM
    2010-12-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-003 - Rev 01
    Valid
    Montelukast sodium, Milled and micr...
    2022-08-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0060
    Valid
    Montelukast Sodium USP/EP/BP
    2022-06-03
    Application Number
    24445
    R1-CEP 2012-003 - Rev 01
    Indian CDSCO WC-0060
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-07-02
    Filing Details
    MONTELUKAST SODIUM
    Montelukast sodium, Milled and micr...
    Montelukast Sodium USP/EP/BP
    Issue/Submission Date
    2010-12-13
    2022-08-19
    2022-06-03
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    Rivaroxaban

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    USDMF

    Found USDMF

    36252
    Active
    RIVAROXABAN
    2021-08-28
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-369 - Rev 00
    Valid
    Rivaroxaban
    2023-01-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0050A
    Valid
    Rivaroxaban IH/EP
    2022-04-20
    Application Number
    36252
    R0-CEP 2021-369 - Rev 00
    Indian CDSCO WC-0050A
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Valid
    2025-04-19
    Filing Details
    RIVAROXABAN
    Rivaroxaban
    Rivaroxaban IH/EP
    Issue/Submission Date
    2021-08-28
    2023-01-16
    2022-04-20
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    Fexofenadine Hydrochloride

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    USDMF

    Found USDMF

    30692
    Active
    FEXOFENADINE HYDROCHLORIDE USP
    2016-06-27
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-256 - Rev 00
    Valid
    Fexofenadine hydrochloride
    2021-09-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0050
    Expired
    Fexofenadine Hydrochloride (USP/EP)...
    2019-06-17
    Application Number
    30692
    R1-CEP 2015-256 - Rev 00
    Indian CDSCO WC-0050
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-06-16
    Filing Details
    FEXOFENADINE HYDROCHLORIDE USP
    Fexofenadine hydrochloride
    Fexofenadine Hydrochloride (USP/EP)...
    Issue/Submission Date
    2016-06-27
    2021-09-16
    2019-06-17
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    Rosuvastatin Calcium

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    USDMF

    Found USDMF

    32651
    Active
    ROSUVASTATIN CALCIUM PROCESS -2
    2018-03-12
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-309 - Rev 00
    Valid
    Rosuvastatin calcium
    2022-01-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0050
    Expired
    Rosuvastatin Calcium (EP)
    2019-06-17
    Application Number
    32651
    R1-CEP 2015-309 - Rev 00
    Indian CDSCO WC-0050
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-06-16
    Filing Details
    ROSUVASTATIN CALCIUM PROCESS -2
    Rosuvastatin calcium
    Rosuvastatin Calcium (EP)
    Issue/Submission Date
    2018-03-12
    2022-01-05
    2019-06-17
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    Rosuvastatin Calcium

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    USDMF

    Found USDMF

    33348
    Active
    ROSUVASTATIN CALCIUM
    2018-11-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-153 - Rev 00
    Valid
    Rosuvastatin calcium, Process 2
    2023-06-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33348
    R1-CEP 2017-153 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ROSUVASTATIN CALCIUM
    Rosuvastatin calcium, Process 2
    Issue/Submission Date
    2018-11-26
    2023-06-22
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    Sitagliptin Phosphate

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    USDMF

    Found USDMF

    33517
    Active
    SITAGLIPTIN PHOSPHATE MONOHYDRATE
    2019-01-17
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-040 - Rev 00
    Valid
    Sitagliptin phosphate monohydrate
    2020-05-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33517
    R0-CEP 2019-040 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    SITAGLIPTIN PHOSPHATE MONOHYDRATE
    Sitagliptin phosphate monohydrate
    Issue/Submission Date
    2019-01-17
    2020-05-12
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    Apixaban

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    USDMF

    Found USDMF

    35799
    Active
    APIXABAN
    2021-03-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0050A4
    Expired
    Apixaban IH
    2021-12-24
    Application Number
    35799
    Indian CDSCO WC-0050A4
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-06-16
    Filing Details
    APIXABAN
    Apixaban IH
    Issue/Submission Date
    2021-03-27
    2021-12-24
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