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    List of Drug Master Files (JDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Merck Group to the Review Authority in Japan (PMDA). Original Data : PMDA

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    01 Bisoprolol fumarate (2)

    02 Calcium folinate (1)

    03 Cetuximab concentrated bulk (2)

    04 Co-carboxylase (1)

    05 Dactinomycin USP (1)

    06 Ella peg Ade Ma Ze (1)

    07 Levofolinate calcium (1)

    08 Media/Media Additives GS2-N Low B12 No Hydrocort (2)

    09 Media/Media Additives ・Trace Element E 1000X Solution (1)

    10 Medium / Medium Additive / IMB8 (1)

    11 Medium / Medium Additive / IMB9 (1)

    12 Medium / Medium Additive / IMF8 (1)

    13 Medium / Medium Additive / PER2 (1)

    14 Medium / Medium Additive ・ CHOKO Production Medium Powerer (2)

    15 Medium / Medium Additive ・ EX-CELL (TM) 6GRO w / L-Glutamine (2)

    16 Medium / Medium Additive ・ IMF9-2X (1)

    17 Medium / Medium Additive ・ TE1 (1)

    18 Medium / Medium Additives FX-208 Cell Culture Medium (1)

    19 Medium / Medium Additives MX-209 Cell Culture Medium (1)

    20 Medium / Medium Additives ・ CHO Kit 2 Iron Chelator Solution (1)

    21 Medium / Medium Additives ・ CHOKO FMA Powerer (2)

    22 Medium / Medium Additives ・ CHOKO FMB Powerer (2)

    23 Medium / Medium Additives ・ CHOKO Stock Culture Medium Powerer (2)

    24 Medium / Medium Additives-EX-CELL (TM) CD Hydrolysate Fusion Animal Coordinate Free, Chemically Defined (1)

    25 Medium / Medium Additives-EX-CELL ACF CHO Medium (1)

    26 Medium / Medium Additives-EX-CELL Advanced (TM) Modified (1)

    27 Medium / Medium Additives-EX-CELL Advanced CHO Feed 1 (1)

    28 Medium / Medium Additives-EX-CELL Advanced CHO Feed 1 (with glucose)　 (2)

    29 Medium / Medium Additives-EX-CELL Advanced CHO Feed 1 (without glucose) (2)

    30 Medium / Medium Additives-SuppAA-1 (1)

    31 Medium / media supplements · EX-CELL (TM) 325 PF CHO Protei n-Free Medium (Modified) (1)

    32 Medium / medium additive · C8862: EX-CELL CHO DHFR - Medium (1)

    33 Medium / medium additive · CHO Feed Bioreactor Supplement (1)

    34 Medium / medium additive · EX-CELL (TM) 302 (Modified 6827 2C) Animal Component Free Media w / o Sodium Bicarbonate (1)

    35 Medium / medium additive · EX-CELL 325 PF CHO Serum-Fr ee Medium for CHO Cells (1)

    36 Medium / medium additive · EX-CELL EBx GRO-Ⅰ Serum-Fre e Media (1)

    37 Medium / medium additive · EX-CELL EBx PRO-Ⅰ Serum-Fre e Media (1)

    38 Medium / medium additive · EX-CELL EBx PRO-Ⅰ Serum-Fre e Medium for Embryonic Stem Cells (1)

    39 Medium / medium additive · Ex-CELL EBx GRO-Ⅰ Serum-Fre e Medium for Embryonic Stem Cells (1)

    40 Medium / medium additive · Fatty Acid Supplement (1)

    41 Medium / medium additive · Sigma EX-CELL 302 Serum-Fr ee Medium for CHO Cells (1)

    42 Medium / medium additive · Sigma EX-CELL PF CHO Mediu m (Modified) (1)

    43 Medium / medium additive · StemlineⅡ Hematopoietic Stem C ell Expansion Medium (1)

    44 Medium / medium additive · X011Sb Cell Culture Medium (1)

    45 Medium/medium additive EX-CELL (R) 293 Serum-Free Medium for HEK 293 Cells (2)

    46 Medium/medium additive R17 (2)

    47 Medium/medium additive R7A-1 (2)

    48 Medium/medium additive R7B-2 w/o L-Tyrosine (2)

    49 Medium/medium additive ・F48 Low B12 no HC (2)

    50 Medium/medium additive ・R34B Medium (1)

    51 Medium/medium additive ・R36 Low B12 (2)

    52 Medium/medium additive ・Trace Element B Solution B (1000X) (1)

    53 Nicotinic acid benzyl ester (1)

    54 Saffinamide mesylate (1)

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    01 Exelead, Inc. (1)

    02 MERCK&CIE (1)

    03 MERCK&CIE KG (1)

    04 Merck & Cie (2)

    05 Merck KGaA (6)

    06 Merck Serono S. A. (2)

    07 SAFC Biosciences, Inc. (29)

    08 SAFC Sigma-Aldrich Corporation. (1)

    09 SIGMA-ALDRICH ISRAEL Ltd. (1)

    10 Sigma-Aldrich Company Limited Trading As SAFC (17)

    11 Sigma-Aldrich Manufacturing, LLC. (6)

    12 Sigma-Aldrich manufacturing, LLC. (3)

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    01 Germany (6)

    02 Switzerland (4)

    03 U.S.A (60)

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    Bisoprolol fumarate

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    MERCK&CIE KG
    2006-04-27
    2005-11-21
    217MF11012
    WEISSHAUSMATTE CH-6460 AL...
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    Bisoprolol fumarate

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    MERCK&CIE
    2014-01-07
    2008-05-15
    220MF10126
    WEISSHAUSMATTE CH-6460 AL...
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    Calcium folinate

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    Merck & Cie
    2011-08-19
    2006-03-17
    218MF10352
    Weisshausmatte CH-6460 Al...
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      Cetuximab concentrated bulk

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      Merck Serono S. A.
      2023-12-06
      2023-12-06
      305MF10129
      Zone industriale de l\'Au...
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        Cetuximab concentrated bulk

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        Merck Serono S. A.
        2020-08-05
        2019-09-11
        301MF10063
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        Co-carboxylase

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        Merck KGaA
        2009-12-07
        2009-12-07
        221MF10266
        Frankfurter Strasse 250 6...
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        Dactinomycin USP

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        SIGMA-ALDRICH ISRAEL Ltd.
        2017-02-13
        2009-08-13
        221MF10187
        13 Kiryat Mada Street, Ha...
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          Ella peg Ade Ma Ze

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          Exelead, Inc.
          2023-11-08
          2018-02-05
          230MF10020
          6925 Guion Road, Indianap...
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          Levofolinate calcium

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          Merck & Cie
          2018-12-03
          2005-12-20
          217MF11281
          Weisshausmatte CH-6460 Al...
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          Medium / medium additive · EX-CELL (TM) 302 (Modified ...

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          SAFC Biosciences, Inc.
          2018-01-15
          2018-01-15
          230MF40003
          13804 West 107th Street L...
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