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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Arch Pharmalabs

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    01 2-Propenoic Acid 3-4-Cyanomethyl-Phenyl 1-1-D (1)

    02 3-2-Chlorophenyl-5-Methylisoxazole-4-Carbonyl Chloride (1)

    03 Aceclofenac (1)

    04 Aciclovir (1)

    05 Adapalene (1)

    06 Amlodipine Besylate (1)

    07 Atorvastatin (2)

    08 Benztropine (1)

    09 Bromhexine Hydrochloride (1)

    10 CAS 265989-34-2 (1)

    11 Cabazitaxel (1)

    12 Cetirizine Dihydrochloride (1)

    13 Citalopram Hydrobromide (2)

    14 Clopidogrel (4)

    15 Cyclophosphamide (1)

    16 Diclofenac Epolamine (1)

    17 Diclofenac Sodium (1)

    18 Docetaxel (2)

    19 Efavirenz (1)

    20 Entacapone (1)

    21 Ephedrine Hydrochloride (1)

    22 Ephedrine Sulfate (1)

    23 Escitalopram Oxalate (1)

    24 Felbamate (1)

    25 Flupirtine (1)

    26 Gemcitabine (2)

    27 Ibuprofen (1)

    28 Imiquimod (1)

    29 Irinotecan Hydrochloride (1)

    30 Lamivudine (2)

    31 Mefenamic Acid (1)

    32 Meloxicam (1)

    33 Metoclopramide Hydrochloride (1)

    34 Milnacipran (1)

    35 Nabumetone (1)

    36 Nebivolol (1)

    37 Nevirapine (1)

    38 Nitrofurantoin (1)

    39 Paclitaxel (1)

    40 Paroxetine Hydrochloride (1)

    41 Perindopril Erbumine (1)

    42 Phenylephrine Hydrochloride (1)

    43 Phosgene (1)

    44 Piroxicam (1)

    45 Prilocaine (1)

    46 Pseudoephedrine Hydrochloride (1)

    47 Ramipril (1)

    48 Rosuvastatin (1)

    49 Stavudine (2)

    50 Trandolapril (1)

    51 Ursodeoxycholic Acid (1)

    52 Valacyclovir (1)

    53 Zidovudine (2)

    54 Blank (3)

    filter

    01 Active (18)

    02 Inactive (24)

    03 Blank (24)

    filter

    01 Valid (12)

    02 Withdrawn by EDQM Failure to CEP procedure (2)

    03 Blank (52)

    filter

    01 221MF10166 (1)

    02 303MF10084 (1)

    03 Blank (64)

    filter

    01 WC-0058 (2)

    02 WC-0221 (2)

    03 WC-254 (6)

    04 Blank (56)

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    Piroxicam

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    USDMF

    Found USDMF

    9118
    Active
    PIROXICAM USP
    1991-05-13
    CEP/COS

    Found CEP/COS

    CEP 2000-034 - Rev 11
    Valid
    Piroxicam
    2024-02-01
    Japanese DMF

    Found JDMF

    221MF10166
    Piroxicam at 505 Hyde Park, Chandiv...
    2009-07-30
    Written Confirmation

    Caution WC

    Indian CDSCO WC-254
    Expired
    Piroxicam (BP/EP)
    2020-05-27
    Application Number
    9118
    CEP 2000-034 - Rev 11
    221MF10166
    Indian CDSCO WC-254
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2023-05-24
    Filing Details
    PIROXICAM USP
    Piroxicam
    Piroxicam at 505 Hyde Park, Chandiv...
    Piroxicam (BP/EP)
    Issue/Submission Date
    1991-05-13
    2024-02-01
    2009-07-30
    2020-05-27
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    Amlodipine Besylate

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    USDMF

    Found USDMF

    23632
    Active
    AMLODIPINE BESYLATE USP
    2010-05-21
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-161 - Rev 00
    Valid
    Amlodipine besilate
    2018-03-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-254
    Expired
    Amlodipine Besylate (BP/EP)
    2020-05-27
    Application Number
    23632
    R1-CEP 2010-161 - Rev 00
    Indian CDSCO WC-254
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2023-05-24
    Filing Details
    AMLODIPINE BESYLATE USP
    Amlodipine besilate
    Amlodipine Besylate (BP/EP)
    Issue/Submission Date
    2010-05-21
    2018-03-29
    2020-05-27
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    Diclofenac Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2002-022 - Rev 06
    Valid
    Diclofenac sodium
    2023-12-04
    Japanese DMF

    Found JDMF

    303MF10084
    Diclofenac Sodium at 505 Hyde Park,...
    2021-06-03
    Written Confirmation

    Caution WC

    Indian CDSCO WC-254
    Expired
    Diclofenace Sodium (EP/BP)
    2020-05-27
    Application Number
    CEP 2002-022 - Rev 06
    303MF10084
    Indian CDSCO WC-254
    Status
    Valid
     
    Expired
    2023-05-24
    Filing Details
    Diclofenac sodium
    Diclofenac Sodium at 505 Hyde Park,...
    Diclofenace Sodium (EP/BP)
    Issue/Submission Date
    2023-12-04
    2021-06-03
    2020-05-27
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    Meloxicam

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    USDMF

    Found USDMF

    15926
    Active
    MELOXICAM USP
    2002-04-05
    CEP/COS

    Found CEP/COS

    CEP 2019-283 - Rev 02
    Valid
    Meloxicam
    2024-01-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-254
    Expired
    Meloxicam BP/EP
    2020-05-27
    Application Number
    15926
    CEP 2019-283 - Rev 02
    Indian CDSCO WC-254
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2023-05-24
    Filing Details
    MELOXICAM USP
    Meloxicam
    Meloxicam BP/EP
    Issue/Submission Date
    2002-04-05
    2024-01-05
    2020-05-27
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    Ursodeoxycholic Acid

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    USDMF

    Found USDMF

    33410
    Active
    URSODIOL USP
    2018-12-17
    CEP/COS

    Found CEP/COS

    CEP 2019-029 - Rev 04
    Valid
    Ursodeoxycholic acid
    2024-02-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0058
    Expired
    Ursodeoxycholic Acid IP/USP/EP/BP/J...
    2020-12-03
    Application Number
    33410
    CEP 2019-029 - Rev 04
    Indian CDSCO WC-0058
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2023-12-02
    Filing Details
    URSODIOL USP
    Ursodeoxycholic acid
    Ursodeoxycholic Acid IP/USP/EP/BP/J...
    Issue/Submission Date
    2018-12-17
    2024-02-07
    2020-12-03
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    Atorvastatin

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    21985
    Inactive
    ATORVASTATIN CALCIUM CRYSTALLINE
    2008-09-15
    CEP/COS

    Found CEP/COS

    CEP 2019-129 - Rev 02
    Valid
    Atorvastatin calcium
    2024-02-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0058
    Expired
    Atorvastatin Calcium IP/USP/EP/BP/J...
    2020-12-03
    Application Number
    21985
    CEP 2019-129 - Rev 02
    Indian CDSCO WC-0058
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Expired
    2023-12-02
    Filing Details
    ATORVASTATIN CALCIUM CRYSTALLINE
    Atorvastatin calcium
    Atorvastatin Calcium IP/USP/EP/BP/J...
    Issue/Submission Date
    2008-09-15
    2024-02-09
    2020-12-03
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    Gemcitabine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23633
    Active
    GEMCITABINE HYDROCHLORIDE USP
    2010-03-31
    CEP/COS

    Caution CEP/COS

    R0-CEP 2011-023 - Rev 01
    Withdrawn by EDQM Failure to CEP procedure
    Gemcitabine hydrochloride, Product ...
    2014-04-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23633
    R0-CEP 2011-023 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by EDQM Failure to CEP procedure
     
    Filing Details
    GEMCITABINE HYDROCHLORIDE USP
    Gemcitabine hydrochloride, Product ...
    Issue/Submission Date
    2010-03-31
    2014-04-25
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    Gemcitabine

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    USDMF

    Found USDMF

    23801
    Active
    GEMCITABINE HYDROCHLORIDE USP (CODE...
    2010-05-26
    CEP/COS

    Caution CEP/COS

    R0-CEP 2011-025 - Rev 01
    Withdrawn by EDQM Failure to CEP procedure
    Gemcitabine hydrochloride, Product ...
    2014-04-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23801
    R0-CEP 2011-025 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Withdrawn by EDQM Failure to CEP procedure
     
    Filing Details
    GEMCITABINE HYDROCHLORIDE USP (CODE...
    Gemcitabine hydrochloride, Product ...
    Issue/Submission Date
    2010-05-26
    2014-04-25
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    Ibuprofen

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    9119
    Inactive
    IBUPROFEN
    1991-05-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-114 - Rev 03
    Valid
    Ibuprofen
    2014-04-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9119
    R1-CEP 2000-114 - Rev 03
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    IBUPROFEN
    Ibuprofen
    Issue/Submission Date
    1991-05-13
    2014-04-15
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    Lamivudine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    21548
    Inactive
    LAMIVUDINE USP
    2008-04-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-362 - Rev 00
    Valid
    Lamivudine
    2021-09-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21548
    R1-CEP 2012-362 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LAMIVUDINE USP
    Lamivudine
    Issue/Submission Date
    2008-04-17
    2021-09-14
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