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List of Drug Master Files (KDMF) for Prestwick3_000651 Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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$ API Ref.Price (USD/KG) : 796Xls
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01 1Medichem S.A.

02 1USV LIMITED.

03 4Cadila Healthcare Limited

04 1Estec Pharma Co., Ltd.

05 6Glenmark Life Sciences Limited

06 1Hana Pharmaceutical Co., Ltd.

07 1Hetero Drugs Limited@[Starting Material Factory 1]_x000D_ Modepro India (p)Ltd_x000D_ @[Starting Material Factory 2]_x000D_ Medilux Laboratories Pvt. Ltd@[Starting material manufacturing plant 3]_x000D_ Cangzhou senary chemicals & T.CO., Ltd

08 5IPCA Laboratories Limited

09 1Inist ST Co., Ltd.

10 1Ipca Laboratories Limited

11 1Leeyeon Pharmaceutical Co., Ltd.

12 1ST Pharm Co., Ltd.

13 1ST Pharm Co., Ltd. @ [Powder manufacturer] Shandong Xinhua Pharmaceutical co., Ltd

14 1Sharon Bio-Medicine Ltd.

15 1Shinpoong Pharmaceutical Co., Ltd.

16 4Zydus Lifesciences Limited

17 1Zydus Lifesciences Limited@Hwail Pharmaceutical Co., Ltd.

18 1[Partial process consignment manufacturing (manufacturing requester)] Dasan Pharmaceutical Co., Ltd. @ Myungmoon Bio Co., Ltd.

19 1[Second Law Manufacturing Factory] Rini Life Science Pvt, Ltd.@Hanseochem Co., Ltd.

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMedichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.

glimepiride

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2007-12-28

Registration Number : 20071228-78-D-30-09

Manufacturer Name : Medichem S.A.

Manufacturer Address : Pollgono Industrial de Celra 17460 Celra. Girona.Spain

Medichem

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothUSV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.

glimepiride

Registrant Name : Sinpo Farm Co., Ltd.

Registration Date : 2011-03-15

Registration Number : 20110315-78-D-89-15

Manufacturer Name : USV LIMITED.

Manufacturer Address : B-1/8,MIDC,Lote,Parshuram,Industrial,Area,Taluka,Khed,District,Ratnagiri,Maharashtra,...

USV Private Limited

03

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glimepiride

Registrant Name : Dasan Pharmaceutical Co., Ltd.

Registration Date : 2013-10-29

Registration Number : 20131029-78-D-129-19

Manufacturer Name : [Partial process consignment...

Manufacturer Address : 342 Deogamsan-ro, Dogo-myeon, Asan-si, Chungcheongnam-do@28, Jaekongdan 2-gil, Hyangn...

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04

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glimepiride

Registrant Name : Seongui Bio Co., Ltd.

Registration Date : 2015-08-10

Registration Number : 20150810-78-D-136-20

Manufacturer Name : Hetero Drugs Limited@[Starti...

Manufacturer Address : Sy. No. 213, 214 & 255, Bonthapally Village, Gummadidala Mandal, Sangareddy District,...

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05

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glimepiride

Registrant Name : ST Pharm Co., Ltd.

Registration Date : 2018-11-09

Registration Number : 20181109-78-D-151-21

Manufacturer Name : ST Pharm Co., Ltd. @ [Powder...

Manufacturer Address : 171 Haean-ro, Danwon-gu, Ansan-si, Gyeonggi-do @Hutian Chemical Industrial Zone, Zibo...

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06

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glimepiride

Registrant Name : Farm East Co., Ltd.

Registration Date : 2023-03-09

Registration Number : 20070928-78-D-23-07(10)

Manufacturer Name : Cadila Healthcare Limited

Manufacturer Address : 291,GIDC Industrial Estate Ankleshwar-393 002, distibharuch, Gujarat state, India

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07

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glimepiride

Registrant Name : IMCD Korea Co., Ltd.

Registration Date : 2017-05-31

Registration Number : 20070928-78-D-23-07(8)

Manufacturer Name : Cadila Healthcare Limited

Manufacturer Address : 291, GIDC Industrial Estate Ankleshwar-393 002, dist:bharuch, Gujarat state, India

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08

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glimepiride

Registrant Name : Daewon Pharmaceutical Co., Ltd.

Registration Date : 2015-09-07

Registration Number : 20070928-78-D-23-07(7)

Manufacturer Name : Zydus Lifesciences Limited

Manufacturer Address : 291, GIDC Estate, Ankleshwar, Gujarat, 393002, India

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09

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glimepiride

Registrant Name : Daesin Pharmaceutical Co., Ltd.

Registration Date : 2021-07-21

Registration Number : 20070928-78-D-23-07(9)

Manufacturer Name : Cadila Healthcare Limited

Manufacturer Address : 291, GIDC, Industrial Estate, Ankleshwar-393 002, Gujarat, India

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10

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glimepiride

Registrant Name : Yebong NCP Co., Ltd.

Registration Date : 2013-11-08

Registration Number : 20070928-78-D-23-07(6)

Manufacturer Name : Cadila Healthcare Limited

Manufacturer Address : 291, GIDC Industrial Estate Ankleshwar-393 002, dist:bharuch, Gujarat state, India

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