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

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$ API Ref.Price (USD/KG) : 106Xls
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01 1INKE, SA

02 1ZCL Chemicals Limited

03 2Dr. Reddy's Laboratories Limited

04 1Moehs Cantabra, SL

05 1Moehs Cantabra, SL_x000D_

06 1Megafine Pharma (P) Ltd.

07 1Ajinomoto Omnichem NV

08 3Aurobindo Pharma Ltd.

09 1Avara Avlon Pharma Services Limited

10 1Divi's Laboratories Ltd

11 1Fuan Pharmaceutical (Group) Co., Ltd.

12 1HL Genomics Co., Ltd. @ Myungin Pharmaceutical Co., Ltd.

13 2Hetero Labs Limited

14 2Hetero Labs Limited(Unit-IX)

15 1Hetero Labs Limited.

16 1Ildong Pharmaceutical Co., Ltd.

17 1Jubilant Pharmova Limited

18 1Menadiona SL

19 1Mylan Laboratories Limited

20 1Myungin Pharmaceutical Co., Ltd.

21 2Qilu Tianhe Pharmaceutical Co., Ltd.

22 1Synthimed Labs Private Limited

23 2UNION QUIMICO FARMACEUTICA, SA

24 2Zhejiang Supor Pharmaceuticals Co., Ltd.

25 1Zhejiang Supor Pharmaceuticals Co.,Ltd.

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothInke S.A: APIs manufacturing plant.

Quetiapine fumarate

Registrant Name : Samoh Pharmaceutical Co., Ltd.

Registration Date : 2013-03-15

Registration Number : 20130315-172-I-248-10

Manufacturer Name : INKE, SA

Manufacturer Address : Area Industrial del Llobregat, C/ Argent, 108755 CASTELLBISBAL, Barcelona, ​​SPAI...

Inke Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

Quetiapine fumarate

Registrant Name : Aging Life Science Co., Ltd.

Registration Date : 2020-06-30

Registration Number : 20200630-172-I-573-23

Manufacturer Name : ZCL Chemicals Limited

Manufacturer Address : 3102/B, GIDC Industrial Estate Ankleshwar City : Ankleshwar-393002 Dist : Bharuch, Gu...

Cohance

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Quetiapine fumarate

Registrant Name : Hanmi Pharmaceutical Co., Ltd.

Registration Date : 2012-10-11

Registration Number : 20120628-172-I-86-04(1)

Manufacturer Name : Dr. Reddy's Laboratories Lim...

Manufacturer Address : Chemical Technical Operations, Unit-VI, APIIC Industrial Estate, Pydibhimavaram, Rana...

Dr Reddy Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMoehs Group, a reference company in the production of pharmaceutical active ingredients.

Quetiapine fumarate

Registrant Name : Wooshin Labotech Co., Ltd.

Registration Date : 2019-06-11

Registration Number : 20150605-172-I-456-16(1)

Manufacturer Name : Moehs Cantabra, SL

Manufacturer Address : Poligono Industrial Requejada, Polanco 39313 (Cantabria), Spain

Moehs Iberica

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMegafine Pharma is engaged in the production of APIs, and advanced intermediates, and offers contract manufacturing services.

Quetiapine fumarate

Registrant Name : IMCD Korea Co., Ltd.

Registration Date : 2013-09-17

Registration Number : 20130917-172-I-326-12

Manufacturer Name : Megafine Pharma (P) Ltd.

Manufacturer Address : Plot No. 1 to 5, 31 to 35 & 48 to 51, 26 & K/201, Lakhmapur, Tal. Dindori, Dist. Nash...

Megafine Pharma

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

Quetiapine fumarate

Registrant Name : Sangjin Corporation

Registration Date : 2012-06-28

Registration Number : 20120628-172-I-86-04

Manufacturer Name : Dr. Reddy's Laboratories Lim...

Manufacturer Address : Chemical Technical Operations, Unit-VI, APIIC Industrial Estate, Pydibhimavaram, Rana...

Dr Reddy Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMoehs Group, a reference company in the production of pharmaceutical active ingredients.

Quetiapine fumarate

Registrant Name : Korea Pharma Co., Ltd.

Registration Date : 2015-06-05

Registration Number : 20150605-172-I-456-16

Manufacturer Name : Moehs Cantabra, SL_x000D_

Manufacturer Address : Poligono Industrial Requejada, Polanco 39313 (Cantabria), Spain_x000D_

Moehs Iberica

08

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

Quetiapine fumarate

Registrant Name : Mirae Pharmchem Co., Ltd.

Registration Date : 2021-04-21

Registration Number : 20200519-172-I-592-22(1)

Manufacturer Name : Hetero Labs Limited(Unit-IX)

Manufacturer Address : Plot No. 2, Hetero Infrastructure SEZ Ltd., N Narasapuram Village, Nakkapalli Mandal,...

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09

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

Quetiapine fumarate

Registrant Name : Mirae Pharmchem Co., Ltd.

Registration Date : 2021-07-05

Registration Number : 20120816-172-I-120-06(2)

Manufacturer Name : Hetero Labs Limited

Manufacturer Address : Sy.No.10, IDA, Gaddapotharam Village, Jinnaram Mandal, Medak District, Telangana, IND...

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10

Discovery on Target
Not Confirmed
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Discovery on Target
Not Confirmed

Quetiapine fumarate

Registrant Name : Myungin Pharmaceutical Co., Ltd.

Registration Date : 2020-10-06

Registration Number : 20201006-172-I-612-24

Manufacturer Name : Myungin Pharmaceutical Co., ...

Manufacturer Address : 17 Balan Industrial Complex-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do

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