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    List of Drug Master Files (KDMF) of Active Pharmaceutical Ingredients (APIs) submitted by Hetero Drugs to the Review Authority in Korea.

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    Abiraterone Acetate

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    Leesung International Co., Ltd.
    2022-12-05
    Wed21-22-ND
    Hetero Labs Limited Unit-...
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    Abiraterone Acetate

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    Hanmi Pharmaceutical Co., Ltd.
    2023-03-03
    Wed21-22-ND(1)
    Hetero Labs Limited Unit-...
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    amlodipine besylate

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    Inist Farm Co., Ltd.
    2017-04-17
    20120120-130-H-183-36(5)
    Hetero Drugs Limited
    India
    Sy.No.213.214&255, Bontha...
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    amlodipine besylate

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    Seongui Bio Co., Ltd.
    2014-03-06
    20120120-130-H-183-36(1)
    Hetero Drugs Limited
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    Sy.No.213,214&255, Bontha...
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    amlodipine besylate

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    Leesung International Co., Ltd.
    2019-10-17
    20120120-130-H-183-36(6)
    Hetero Drugs Limited
    India
    Sy.No.213,214&255, Bontha...
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    amlodipine besylate

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    Sungwoo Chemical Co., Ltd.
    2016-04-19
    20120120-130-H-183-36(4)
    Hetero Drugs Limited
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    Sy.No.213,214&255, Bontha...
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    amlodipine besylate

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    Hanmi Pharmaceutical Co., Ltd.
    2016-02-25
    20120120-130-H-183-36(3)
    Hetero Drugs Limited
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    Sy.No.213,214&255, Bontha...
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    amlodipine besylate

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    Celltrion Pharmaceutical Co., Ltd.
    2015-04-15
    20120120-130-H-183-36(2)
    Hetero Drugs Limited.
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    Sy.No.213,214&255, Bontha...
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    amlodipine besylate

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    Novartis Korea Co., Ltd.
    2022-10-18
    20120120-130-H-183-36(7)
    Hetero Drugs Limited
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    Sy.No.213,214&255, Bontha...
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    amlodipine besylate

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    Wonpoong Pharmaceutical Co., Ltd.
    2012-01-20
    20120120-130-H-183-36
    Hetero Drugs Limited
    India
    Sy.No.213,214&255, Bontha...
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    amlodipine besylate

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    Foosung Bio Co., Ltd.
    2023-09-08
    20120120-130-H-183-36(8)
    Hetero Drugs Limited
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    Sy.No.213,214&255, Bontha...
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    Apremilast

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    Leesung International Co., Ltd.
    2020-12-17
    Wed21-17-ND
    Hetero Drugs Limited (Uni...
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    Sy. No.213, 214 & 255, Bo...
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    aprepitant

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    Hwail Pharmaceutical Co., Ltd.
    2016-06-17
    Number 3838-1-ND(1)
    Hetero Drugs Limited
    India
    Sy.No.213,214&255, Bontha...
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    aprepitant

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    Wonpoong Pharmaceutical Co., Ltd.
    2012-04-27
    Number 3838-1-ND
    Hetero Drugs Limited
    India
    Sy.No.213,214&255, Bontha...
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    Aripiprazole

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    Pharmapia Co., Ltd.
    2019-04-23
    20190314-209-J-189(2)
    Hetero Labs Limited (Unit...
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    Sy.No.10, IDA, Gaddapotha...
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    Aripiprazole

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    Youngjin Pharmaceutical Co., Ltd.
    2019-04-22
    20190314-209-J-189(1)
    Hetero Labs Limited (Unit...
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    Sy.No.10, IDA, Gaddapotha...
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    Aripiprazole

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    Leesung International Co., Ltd.
    2019-03-14
    20190314-209-J-189
    Hetero Labs Limited (Unit...
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    Survey No.10, IDA, Gaddap...
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    Aripiprazole

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    Unimed Pharmaceutical Co., Ltd.
    2020-06-22
    20190314-209-J-189(4)
    Hetero Labs Limited (Unit...
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    Sy.No.10, IDA, Gaddapotha...
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    Aripiprazole

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    Hwail Pharmaceutical Co., Ltd.
    2019-07-16
    20190314-209-J-189(3)
    Hetero Labs Limited (Unit...
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    Survey No.10, IDA, Gaddap...
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    Atomoxetine hydrochloride

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    Leesung International Co., Ltd.
    2012-05-25
    Number 3838-3-ND
    Hetero Labs Limited
    India
    Sy.No.10, IDA, Gaddapotha...
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    Atomoxetine hydrochloride

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    Leesung International Co., Ltd.
    2013-07-04
    Number 3838-3-ND(3)
    Hetero Labs Limited
    India
    Sy.No.10, IDA, Gaddapotha...
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    Atomoxetine hydrochloride

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    Hansol Pharma Co., Ltd.
    2014-09-19
    Number 3838-3-ND(5)
    Hetero Labs Limited
    India
    Survey No.10, IDA, Gaddap...
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    Atomoxetine hydrochloride

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    Hwanin Pharmaceutical Co., Ltd.
    2013-05-22
    Number 3838-3-ND(2)
    Hetero Labs Limited
    India
    Sy.No.10, IDA, Gaddapotha...
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    Atomoxetine hydrochloride

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    Myungin Pharmaceutical Co., Ltd.
    2013-01-30
    Number 3838-3-ND(1)
    Hetero Labs Limited
    India
    Sy.No.10, IDA, Gaddapotha...
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    Atomoxetine hydrochloride

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    Pharma Solution Co., Ltd.
    2023-08-28
    Number 3838-3-ND(6)
    Hetero Labs Limited
    India
    Sy.No.10, IDA, Gaddapotha...
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    Atorvastatin calcium hydrate

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    Neo Co., Ltd.
    2023-07-19
    20200318-132-H-354-44(3)
    Hetero Labs Limited (Unit...
    India
    Plot No.2, Hetero Infrast...
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    Atorvastatin calcium hydrate

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    Leesung International Co., Ltd.
    2020-03-18
    20200318-132-H-354-44
    Hetero Labs Limited (Unit...
    India
    Plot No.2, Hetero Infrast...
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    Atorvastatin calcium hydrate

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    Pharma Solution Co., Ltd.
    2022-12-14
    20200318-132-H-354-44(2)
    Hetero Labs Limited (Unit...
    India
    Plot No. 2, Hetero Infras...
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    Atorvastatin calcium hydrate

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    Agerson Bio Co., Ltd.
    2022-02-22
    20200318-132-H-354-44(1)
    Hetero Labs Limited (Unit...
    India
    Plot No. 2, Hetero Infras...
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    Bortezomib

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    Leesung International Co., Ltd.
    2013-04-09
    Number 3838-6-ND
    Hetero Labs Limited
    India
    Sy.No.10, IDA, Gaddapotha...
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    Bortezomib

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    Boryeong Co., Ltd.
    2015-03-13
    Number 3838-6-ND(1)
    Hetero Labs Limited
    India
    Sy.No.10, IDA, Gaddapotha...
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    Capecitabine

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    Leesung International Co., Ltd.
    2021-03-10
    20210310-209-J-685
    Hetero Labs Limited (Unit...
    India
    Sy.No.10, IDA,Gaddapothar...
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    Cilazapril

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    Eltech Pharmachem Co., Ltd.
    2018-10-11
    20181011-209-J-158
    Hetero Labs Limited
    India
    Sy.No. 10, IDA, Gaddapoth...
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    Cinacalcet hydrochloride

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    Pharmapia Co., Ltd.
    2018-04-20
    Number 331-4-ND(1)
    Hetero Drugs Limited (Uni...
    India
    Unit-IX, Plot No.1, Heter...
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    Cinacalcet hydrochloride

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    Hwail Pharmaceutical Co., Ltd.
    2016-11-18
    Number 331-4-ND
    Hetero Drugs Limited (Uni...
    India
    Unit-IX, Plot No.1, Heter...
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    Dabigatran etexilate mesylate

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    Mpeak Korea Co., Ltd.
    2016-11-22
    Number 55-2-ND
    Hetero Drugs Limited (Uni...
    India
    Plot No.1, Hetero Infrast...
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    donepezil hydrochloride

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    Kolon Pharmaceutical Co., Ltd.
    2018-05-10
    20120919-158-I-131-10(3)
    Hetero Drugs Limited
    India
    Sy.No.213. 214&255, Bonth...
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    donepezil hydrochloride

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    HK Innoen Co., Ltd.
    2014-08-29
    20120919-158-I-131-10(1)
    Hetero Drugs Limited
    India
    Sy.No.213. 214&255, Bonth...
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    donepezil hydrochloride

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    Youngjin Pharmaceutical Co., Ltd.
    2017-09-12
    20120919-158-I-131-10(2)
    Hetero Drugs Limited
    India
    Sy.No.213. 214&255, Bonth...
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    donepezil hydrochloride

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    Wonpoong Pharmaceutical Co., Ltd.
    2012-09-19
    20120919-158-I-131-10
    Hetero Drugs Limited
    India
    Sy.No.213. 214&255, Bonth...
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    donepezil hydrochloride

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    Sungwoo Chemical Co., Ltd.
    2018-06-25
    20120919-158-I-131-10(4)
    Hetero Drugs Limited
    India
    Sy.No.213. 214&255, Bonth...
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    Dorzolamide hydrochloride

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    Leesung International Co., Ltd.
    2021-07-28
    20210728-209-J-927
    Hetero Drugs Limited Unit...
    India
    Survey. No's 213, 214 and...
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    duloxetine hydrochloride

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    Pharmapia Co., Ltd.
    2012-11-07
    Number 3838-4-ND(1)
    Hetero Drugs Limited.
    India
    Sy.No.213.214&255, Bontha...
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    duloxetine hydrochloride

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    Wonpoong Pharmaceutical Co., Ltd.
    2012-07-13
    Number 3838-4-ND
    Hetero Drugs Limited
    India
    Sy.No.213.214&255, Bontha...
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    duloxetine hydrochloride

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    Myungin Pharmaceutical Co., Ltd.
    2018-01-16
    Number 3838-4-ND(2)
    Hetero Drugs Limited
    India
    Sy. No.213. 214&255, Bont...
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    Dutasteride

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    Wonpoong Pharmaceutical Co., Ltd.
    2020-02-03
    Number 473-21-ND(1)
    Hetero Labs Limited (Unit...
    India
    Sy.No.10, IDA, Gaddapotha...
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    Dutasteride

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    Sungwoo Chemical Co., Ltd.
    2019-06-18
    Number 473-21-ND
    Hetero Labs Limited (Unit...
    India
    Sy.No.10, IDA, Gaddapotha...
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    Entecavir

    PDF Supplier PDF
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    Seongui Bio Co., Ltd.
    2015-07-27
    Number 5898-2-ND
    Hetero Drugs Limited
    India
    Sy. No. 213, 214 & 255, B...
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    Enzalutamide

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    Mpeak Korea Co., Ltd.
    2022-12-05
    Wed812-19-ND
    Hetero Labs Limited (Unit...
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    Mirae Farmchem Co., Ltd.
    2021-04-21
    20180604-209-J-223(8)
    Hetero Labs Limited
    India
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