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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Lee Pharma

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    01 Alogliptin Benzoate (1)

    02 Apixaban (1)

    03 Bempedoic Acid (1)

    04 Bilastine (1)

    05 Brivaracetam (1)

    06 Cariprazine Hydrochloride (1)

    07 Clopidogrel (1)

    08 Dabigatran Etexilate Mesylate (1)

    09 Dapagliflozin (1)

    10 Dapagliflozin Propanediol Monohydrate (1)

    11 Dexlansoprazole (1)

    12 Elagolix Sodium (1)

    13 Empagliflozin (1)

    14 Esomeprazole Magnesium (2)

    15 Esomeprazole Sodium (1)

    16 Ferric Carboxymaltose (1)

    17 Ferric Maltol (1)

    18 Flurbiprofen (1)

    19 Ibandronate Sodium (1)

    20 Itraconazole (1)

    21 Ivabradine Hydrochloride (1)

    22 Lacosamide (1)

    23 Lansoprazole (1)

    24 Linagliptin (1)

    25 Linezolid (1)

    26 Lobeglitazone (1)

    27 Lurasidone Hydrochloride (1)

    28 Mirogabalin Besylate (1)

    29 Montelukast Sodium (1)

    30 Moxifloxacin Hydrochloride (1)

    31 Olanzapine (1)

    32 Omeprazole (1)

    33 Omeprazole Magnesium (1)

    34 Pantoprazole Magnesium (1)

    35 Pantoprazole Sodium (1)

    36 Posaconazole (1)

    37 Prasugrel Hydrochloride (1)

    38 Pregabalin (1)

    39 Rabeprazole (1)

    40 Raltegravir Potassium (1)

    41 Relugolix (1)

    42 Rivaroxaban (1)

    43 Rosuvastatin Calcium (1)

    44 Roxadustat (1)

    45 Sacubitril Sodium (1)

    46 Saxagliptin (1)

    47 Sertraline Hydrochloride (1)

    48 Silodosin (1)

    49 Sitagliptin Hydrochloride (1)

    50 Sitagliptin Phosphate (2)

    51 Tamsulosin (1)

    52 Tegoprazan (1)

    53 Teneligliptin (2)

    54 Ticagrelor (1)

    55 Tofacitinib Citrate (1)

    56 Upadacitinib (1)

    57 Valsartan (1)

    58 Varenicline Tartrate (2)

    59 Venlafaxine Hydrochloride (1)

    60 Vildagliptin (1)

    61 Vonoprazan Fumarate (1)

    62 Voriconazole (1)

    63 Blank (2)

    filter

    01 Active (32)

    02 Blank (36)

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    01 Expired (1)

    02 Valid (12)

    03 Blank (55)

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    01 303MF10142 (1)

    02 303MF10159 (1)

    03 306MF10014 (1)

    04 Blank (65)

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    01 WC-0186 (14)

    02 WC-0186A2 (1)

    03 WC-0186A4 (5)

    04 WC-0421 (1)

    05 Blank (47)

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    Bilastine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36288
    Active
    BILASTINE
    2021-09-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10159
    Bilastine at SY. No. :257 & 258/1, ...
    2021-10-21
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186A4
    Expired
    Bilastine IH
    2020-05-29
    Application Number
    36288
    303MF10159
    Indian CDSCO WC-0186A4
    Status
    Active
    Fees Unpaid
    N/A
     
    Expired
    2022-07-28
    Filing Details
    BILASTINE
    Bilastine at SY. No. :257 & 258/1, ...
    Bilastine IH
    Issue/Submission Date
    2021-09-16
    2021-10-21
    2020-05-29
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    Esomeprazole Magnesium

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    USDMF

    Found USDMF

    34572
    Active
    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE U...
    2020-02-18
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-334 - Rev 00
    Valid
    Esomeprazole magnesium dihydrate
    2022-05-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186
    Expired
    Esomeprazole Magnesium dihydrate (P...
    2019-09-27
    Application Number
    34572
    R0-CEP 2021-334 - Rev 00
    Indian CDSCO WC-0186
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Expired
    2022-07-28
    Filing Details
    ESOMEPRAZOLE MAGNESIUM TRIHYDRATE U...
    Esomeprazole magnesium dihydrate
    Esomeprazole Magnesium dihydrate (P...
    Issue/Submission Date
    2020-02-18
    2022-05-03
    2019-09-27
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    Lansoprazole

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    USDMF

    Found USDMF

    26799
    Active
    LANSOPRAZOLE USP
    2013-01-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-191 - Rev 01
    Valid
    Lansoprazole
    2023-08-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186
    Expired
    Lansoprazole (USP)
    2019-09-27
    Application Number
    26799
    R1-CEP 2010-191 - Rev 01
    Indian CDSCO WC-0186
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Expired
    2022-07-28
    Filing Details
    LANSOPRAZOLE USP
    Lansoprazole
    Lansoprazole (USP)
    Issue/Submission Date
    2013-01-07
    2023-08-01
    2019-09-27
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    Omeprazole

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    USDMF

    Found USDMF

    37921
    Active
    OMEPRAZOLE
    2023-05-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-006 - Rev 03
    Valid
    Omeprazole, Micronised
    2023-01-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186
    Expired
    Omeprazole (BP/USP/EP)
    2019-09-27
    Application Number
    37921
    R1-CEP 2007-006 - Rev 03
    Indian CDSCO WC-0186
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Expired
    2022-07-28
    Filing Details
    OMEPRAZOLE
    Omeprazole, Micronised
    Omeprazole (BP/USP/EP)
    Issue/Submission Date
    2023-05-25
    2023-01-23
    2019-09-27
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    Rosuvastatin Calcium

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    USDMF

    Found USDMF

    35115
    Active
    ROSUVASTATIN CALCIUM USP
    2020-09-27
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-204 - Rev 00
    Valid
    Rosuvastatin calcium
    2022-12-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186
    Expired
    Rosuvastatin Calcium (Ph.Eur)
    2019-09-27
    Application Number
    35115
    R0-CEP 2022-204 - Rev 00
    Indian CDSCO WC-0186
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Expired
    2022-07-28
    Filing Details
    ROSUVASTATIN CALCIUM USP
    Rosuvastatin calcium
    Rosuvastatin Calcium (Ph.Eur)
    Issue/Submission Date
    2020-09-27
    2022-12-14
    2019-09-27
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    Sitagliptin Phosphate

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    USDMF

    Found USDMF

    35198
    Active
    SITAGLIPTIN PHOSPHATE USP
    2020-09-30
    CEP/COS

    Found CEP/COS

    CEP 2022-042 - Rev 00
    Valid
    Sitagliptin phosphate monohydrate
    2024-03-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186A4
    Expired
    Sitagliptin Phosphate Monohydrate E...
    2020-05-29
    Application Number
    35198
    CEP 2022-042 - Rev 00
    Indian CDSCO WC-0186A4
    Status
    Active
    Fees Unpaid
    Reviewed
    Valid
     
    Expired
    2022-07-28
    Filing Details
    SITAGLIPTIN PHOSPHATE USP
    Sitagliptin phosphate monohydrate
    Sitagliptin Phosphate Monohydrate E...
    Issue/Submission Date
    2020-09-30
    2024-03-06
    2020-05-29
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    Varenicline Tartrate

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    USDMF

    Found USDMF

    31576
    Active
    VARENICLINE BASE (INTERMEDIATE OF V...
    2017-03-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    303MF10142
    Varenicline Tartrate at SY, No. :25...
    2021-09-02
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186A4
    Expired
    Varenicline Tartrate IH
    2020-05-29
    Application Number
    31576
    303MF10142
    Indian CDSCO WC-0186A4
    Status
    Active
    Fees Unpaid
    N/A
     
    Expired
    2022-07-28
    Filing Details
    VARENICLINE BASE (INTERMEDIATE OF V...
    Varenicline Tartrate at SY, No. :25...
    Varenicline Tartrate IH
    Issue/Submission Date
    2017-03-30
    2021-09-02
    2020-05-29
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    Esomeprazole Magnesium

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2016-284 - Rev 00
    Valid
    Esomeprazole magnesium trihydrate
    2023-06-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0421
    Expired
    Esomeprazole Magnesium Dihydrate IH...
    2018-05-14
    Application Number
    R1-CEP 2016-284 - Rev 00
    Indian CDSCO WC-0421
    Status
    Valid
     
    Expired
    2021-05-16
    Filing Details
    Esomeprazole magnesium trihydrate
    Esomeprazole Magnesium Dihydrate IH...
    Issue/Submission Date
    2023-06-12
    2018-05-14
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    Esomeprazole Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2022-001 - Rev 00
    Valid
    Esomeprazole sodium
    2022-11-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186
    Expired
    Esomeprazole Sodium (IH)
    2019-09-27
    Application Number
    R0-CEP 2022-001 - Rev 00
    Indian CDSCO WC-0186
    Status
    Valid
     
    Expired
    2022-07-28
    Filing Details
    Esomeprazole sodium
    Esomeprazole Sodium (IH)
    Issue/Submission Date
    2022-11-17
    2019-09-27
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    Lacosamide

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-223 - Rev 00
    Valid
    Lacosamide
    2021-10-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0186A2
    Expired
    Lacosamide EP
    2020-05-06
    Application Number
    R0-CEP 2019-223 - Rev 00
    Indian CDSCO WC-0186A2
    Status
    Valid
     
    Expired
    2022-07-28
    Filing Details
    Lacosamide
    Lacosamide EP
    Issue/Submission Date
    2021-10-21
    2020-05-06
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