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List of Drug Master Files (KDMF) for DSSTox_CID_3270 Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 1GRANULES INDIA LIMITED

02 8Granules India Limited

03 1Granules India Ltd

04 2Granules India Ltd.

05 3M/s Granules India Limited

06 2USV Private Limited

07 2USV Private Ltd

08 1USV Private Ltd.

09 3FARMHISPANIA SA@ROLABO OUTSOURCING SL

10 2Farmhispania SA@ROLABO OUTSOURCING, SL

11 1Abhilasha Pharma Pvt. Ltd.

12 4Auro Laboratories Limited

13 1Aurobindo Pharma Limited

14 3Aurobindo Pharma Ltd.

15 3Exemed Pharmaceuticals

16 1Exemed pharmaceuticals

17 2Harman Finochem LTD.

18 2Harman Finochem Limited

19 1Harman Finochem Ltd

20 1Harman Finochem limited

21 1IPCA Laboratories Limited

22 1Kyungdong Pharmaceutical Co., Ltd.

23 1Laurus Labs Limited

24 1Lee Yeon Pharmaceutical Co., Ltd.

25 4Merck Sante sas (Production Center of Calais)

26 2Merck Sante sas (Production Center of Meyzieu)

27 1Ningxia HengKang Technology Co., Ltd

28 3Shandong Keyuan Pharmaceutical Co., Ltd.

29 11Shouguang Fukang Pharmaceutical Co., Ltd

30 1Shouguang Fukang Pharmaceutical Co., Ltd@Dasan Medichem Co., Ltd

31 1Shouguang Fukang Pharmaceutical.Co.,Ltd

32 2Sohan Healthcare Pvt Ltd

33 1Sohan Healthcare Pvt Ltd.

34 1Sun Pharm. Ltd

35 1Tianjin Pacific Chemical & Pharmaceutical Co., Ltd

36 2UQUIFA MEXICO SA de CV

37 3Uquifa Mexico SA of CV

38 3Vistin Pharma AS

39 16Wanbury Limited

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Metformin hydrochloride

Registrant Name : Agerson Bio Co., Ltd.

Registration Date : 2023-01-13

Registration Number : 20050831-37-C-34-05(13)

Manufacturer Name : M/s Granules India Limited

Manufacturer Address : Plot No.: 15A/1, Phase-Ⅲ, IDA, Jeedimetla, Quthbullapur (M), Medchal-Malkajgiri Dis...

Granules India

02

  • fda
  • EDQM
  • WHO-GMP

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

Metformin hydrochloride

Registrant Name : Korea MSD Co., Ltd.

Registration Date : 2018-06-21

Registration Number : 20050831-37-C-40-08(4)

Manufacturer Name : USV Private Limited

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

USV Private Limited

03

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AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFarmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.

Metformin hydrochloride

Registrant Name : Hanol Biopharma Co., Ltd.

Registration Date : 2022-01-06

Registration Number : 20050831-37-C-42-10(A)

Manufacturer Name : Farmhispania SA@ROLABO OUTSO...

Manufacturer Address : Passeig del Riu Besos, 9-10, 08160 MONTMELO_x000D_ (BARCELONA), SPAIN@Polígono Indus...

Farmhispania

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Metformin hydrochloride

Registrant Name : Insung Trading Co., Ltd.

Registration Date : 2022-05-17

Registration Number : 20050831-37-C-34-05(11)

Manufacturer Name : Granules India Limited

Manufacturer Address : Plot No.: 15A/1, Phase-Ⅲ, IDA, Jeedimetla, Quthbullapur (M), Medchal-Malkajgiri Dis...

Granules India

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Metformin hydrochloride

Registrant Name : Insung Trading Co., Ltd.

Registration Date : 2020-07-21

Registration Number : 20200721-37-C-387-28

Manufacturer Name : Granules India Limited

Manufacturer Address : H.No. 6-5 & 6-11, Temple Road, Bonthapally Village Gummadidala Mandal Sangareddy Dist...

Granules India

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Metformin hydrochloride

Registrant Name : Wonpung Pharmaceutical Co., Ltd.

Registration Date : 2011-10-07

Registration Number : 20050831-37-C-34-05(7)

Manufacturer Name : Granules India Limited

Manufacturer Address : Plot No.: 15A/1, Phase-Ⅲ, IDA, Jeedimetla, Quthbullapur (M), Medchal-Malkajgiri Dis...

Granules India

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Metformin hydrochloride

Registrant Name : Insung Trading Co., Ltd.

Registration Date : 2012-10-12

Registration Number : 20050831-37-C-34-05(9)

Manufacturer Name : Granules India Limited

Manufacturer Address : Plot No.: 15A/1, IDA, Phase-Ⅲ, Jeedimetla, Quthbullapur Mandal, Medchal-Malkajgiri ...

Granules India

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Metformin hydrochloride

Registrant Name : Youngpoong Pharmaceutical Co., Ltd.

Registration Date : 2011-08-19

Registration Number : 20050831-37-C-34-05(6)

Manufacturer Name : Granules India Ltd.

Manufacturer Address : Plot No.: 15A/1, IDA, Phase-Ⅲ, IDA Jeedimetla, Quthbullapur Mandal, Medchal-Malkajg...

Granules India

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Metformin hydrochloride

Registrant Name : Palm East Co., Ltd.

Registration Date : 2021-10-20

Registration Number : 20050831-37-C-34-05(10)

Manufacturer Name : M/s Granules India Limited

Manufacturer Address : Plot No.: 15A/1, Phase-Ⅲ, IDA, Jeedimetla, Quthbullapur (M), Medchal-Malkajgiri Dis...

Granules India

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Metformin hydrochloride

Registrant Name : Base Farm Co., Ltd.

Registration Date : 2011-12-09

Registration Number : 20050831-37-C-34-05(8)

Manufacturer Name : Granules India Limited

Manufacturer Address : 15A/1, Phase-Ⅲ IDA, Jeedimetla, Hyderabad-500055

Granules India