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    Micronization Enhances Bioavailability in Dry Powder Inhalers

    17 Mar 2026

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    01 1Aclidinium Bromide

    02 1Aprepitant

    03 2Arformoterol Tartrate

    04 1Asenapine Maleate

    05 1Bimatoprost

    06 1Bimatoprost Grenod

    07 1Carvedilol

    08 1Clevidipine

    09 1Daprodustat

    10 1Daridorexant

    11 2Eletriptan Hydrobromide

    12 1Enalapril Maleate

    13 1Ensifentrine

    14 1Formoterol Fumarate

    15 1Glycopyrronium Bromide

    16 1Glycopyrronium Tosylate

    17 1Granisetron

    18 2Granisetron Hydrochloride

    19 1Imidapril Hydrochloride

    20 1Indacaterol Acetate

    21 1Indacaterol Maleate

    22 1Latanoprost

    23 1Latanoprostene Bunod

    24 1Loratadine

    25 1Mavacamten

    26 2Montelukast Sodium

    27 1Olanzapine

    28 1Olodaterol Hydrochloride

    29 1Ondansetron

    30 1Ondansetron Hydrochloride

    31 1Otilonium Bromide

    32 1Prasugrel

    33 1Prasugrel Hydrochloride

    34 1Quetiapine Hemifumarate

    35 1Revefenacin

    36 1Risperidone

    37 1Rivaroxaban

    38 1Roflumilast

    39 1Rotigotine

    40 1Salmeterol Xinafoate

    41 1Solriamfetol Hydrochloride

    42 1Tafamidis

    43 1Tafamidis Meglumine

    44 1Tafluprost

    45 1Tetrabenazine

    46 1Tiotropium Bromide

    47 1Travoprost

    48 1Umeclidinium Bromide

    49 1Vilanterol Trifenatate

    50 1Zolmitriptan

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    01

    Formoterol Fumarate

    Spain

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-06-16

    Pay. Date : 2017-05-10

    DMF Number : 16628

    Submission : 2003-06-03

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2006-024 - Rev 03

    Issue Date : 2025-03-27

    Type : Chemical

    Substance Number : 1724

    Status : Valid

     JDMF arrow-down
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    Registration Number : 224MF10042

    Registrant's Address : Area Industrial del Llobregat, C/Argent 1,08755 Castellbisbal Barcelona SPAIN

    Initial Date of Registration : 2012-02-28

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
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    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2013-08-19

    Registration Number : 20130819-187-I-288-06

    Manufacturer Name : INKE SA

    Manufacturer Address : Argent,1, Area Industrial del Llobregat, Castellbisbal 08755 (Barcelona), Spain.

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    Available Reg. Filing : CN
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    02

    Granisetron Hydrochloride

    Spain

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-12-10

    Pay. Date : 2021-12-07

    DMF Number : 17346

    Submission : 2004-04-05

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2008-030 - Rev 01

    Issue Date : 2016-03-17

    Type : Chemical

    Substance Number : 1695

    Status : Valid

     JDMF arrow-down
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    Registration Number : 218MF10350

    Registrant's Address : Area Industrial del Llobregat, C/Argent 1,08755 Castellbisbal Barcelona SPAIN

    Initial Date of Registration : 2006-03-17

    Latest Date of Registration :

    EU-WC NDC KDMF arrow-down
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    Registrant Name : Hana Pharmaceutical Co., Ltd.

    Registration Date : 2014-04-30

    Registration Number : 20130314-177-I-205-02(1)

    Manufacturer Name : INKE, SA

    Manufacturer Address : Area Industrial del Llobregat, C/ Argent, 1 08755 CASTELLBISBAL, Barcelona, ​​SPAIN

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    03

    Aprepitant

    Spain

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2022-05-31

    Pay. Date : 2022-05-16

    DMF Number : 35497

    Submission : 2022-04-26

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2022-247 - Rev 00

    Issue Date : 2024-10-29

    Type : Chemical

    Substance Number : 2757

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    04

    Glycopyrronium Bromide

    Spain

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-02-16

    Pay. Date : 2017-07-06

    DMF Number : 31836

    Submission : 2017-07-22

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2017-182 - Rev 00

    Issue Date : 2023-08-17

    Type : Chemical

    Substance Number : 1783

    Status : Valid

     JDMF EU-WC NDC arrow-down
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    NDC Package Code : 64567-0018

    Start Marketing Date : 2017-07-28

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2020-11-03

    Registration Number : 20201103-211-J-782

    Manufacturer Name : INKE SA

    Manufacturer Address : C/Argent 1, Area Industrial del Llobregat 08755 Castellbisbal Barcelona, ​​Spain

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    Available Reg. Filing : CN
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    05

    Ondansetron Hydrochloride

    Spain

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16317

    Submission : 2002-12-13

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2005-056 - Rev 00

    Issue Date : 2012-05-24

    Type : Chemical

    Substance Number : 2016

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT arrow-down
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    06

    Risperidone

    Spain

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-06-09

    Pay. Date : 2021-06-04

    DMF Number : 15682

    Submission : 2001-10-23

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2006-054 - Rev 00

    Issue Date : 2012-07-16

    Type : Chemical

    Substance Number : 1559

    Status : Valid

     JDMF EU-WC NDC KDMF arrow-down
    ✖

    Registrant Name : Sam-O Pharmaceutical Co., Ltd.

    Registration Date : 2005-08-31

    Registration Number : 20050831-10-C-84-08

    Manufacturer Name : INKE SA

    Manufacturer Address : Area Industrial del Llobregat, C/Argent 1, 08755 Castellbisbal Barcelona

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    Available Reg. Filing : CN
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    07

    Salmeterol Xinafoate

    Spain

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-08-12

    Pay. Date : 2015-05-20

    DMF Number : 23914

    Submission : 2010-06-23

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2007-127 - Rev 00

    Issue Date : 2014-06-16

    Type : Chemical

    Substance Number : 1765

    Status : Valid

     JDMF EU-WC NDC KDMF VMF CN arrow-down
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    Available Reg. Filing : CN
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    08

    Tiotropium Bromide

    Spain

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2021-04-30

    Pay. Date : 2020-01-13

    DMF Number : 34410

    Submission : 2020-03-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2019-337 - Rev 02

    Issue Date : 2025-10-24

    Type : Chemical

    Substance Number : 2420

    Status : Valid

     JDMF EU-WC NDC KDMF VMF CN arrow-down
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    Available Reg. Filing : CN
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    09

    Aclidinium Bromide

    Spain

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2023-06-14

    Pay. Date : 2023-04-21

    DMF Number : 36437

    Submission : 2023-03-16

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 64567-0028

    Start Marketing Date : 2022-01-13

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF ASMF arrow-down
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    Available Reg. Filing : ASMF
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    10

    Arformoterol Tartrate

    Spain

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-04-12

    Pay. Date : 2018-07-17

    DMF Number : 32990

    Submission : 2018-07-25

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 64567-0020

    Start Marketing Date : 2018-07-19

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF CN arrow-down
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    Available Reg. Filing : CN
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    Inke S.a is a supplier offers 51 products (APIs, Excipients or Intermediates).

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