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

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$ API Ref.Price (USD/KG) : 635Xls
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01 2Centrient Pharmaceuticals India Private Limited

02 1Ajinomoto Omnichem NV

03 1Amoli Organics Private Limited

04 1Asia Chemical Industries Ltd. Teva-Tech site

05 18Biocon Limited

06 1CTX Life Sciences Pvt. Ltd

07 2CTX Life Sciences Pvt. Ltd.

08 1Cadchem Laboratories Limited

09 1Engichem Life Sciences Co., Ltd.

10 1Estifarm Co., Ltd.

11 1H.L.G.Nomics Co., Ltd.

12 1Hanmi Precision Chemical Co., Ltd.

13 1Ildong Pharmaceutical Co., Ltd.

14 1Inistesti Co., Ltd.

15 1Jeil Pharmaceutical Co., Ltd. @ MFC Co., Ltd.

16 1Korea Biochem Pharmaceutical Co., Ltd.

17 1Kyungbo Pharmaceutical Co., Ltd.

18 1Lee Pharma Limited

19 1Lek Pharmaceuticals dd

20 1Lonza AG

21 1Lupin Limited

22 1MFC Corporation

23 16MSN Laboratories Private Limited

24 1Melody Healthcare PVT. LTD

25 9Melody Healthcare Pvt. Ltd

26 1Myungmoon Bio Co., Ltd.

27 2Nantong Chanyoo Pharmatech Co., Ltd. Ltd

28 1Nosch Labs Private Limited (Unit-II)

29 1PT Kimia Farma Sungwun Pharmacopia@Zhejiang LEPU Pharmaceutical Co., Ltd.

30 1Ridox Bio Co., Ltd.

31 2Ruyuan HEC Pharm Co., Ltd.

32 1Ruyuan Hec Pharma Co., Ltd

33 1Ruyuan Hec Pharma Co., Ltd.

34 2Ruyuan Hec Pharma Co.,Ltd

35 2Samjin Pharmaceutical Co., Ltd.

36 2Shaoxing Jingxin Pharmaceutical Co., Ltd.

37 1Teva API India Private Limited

38 1Yuhan Chemical Co., Ltd.

39 2Zhejiang Jiangbei Pharmaceutical Co., Ltd.

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCentrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

Rosuvastatin calcium

Registrant Name : Daeshin Pharmaceutical Co., Ltd.

Registration Date : 2020-12-17

Registration Number : 20200707-209-J-677(1)

Manufacturer Name : Centrient Pharmaceuticals In...

Manufacturer Address : Bhai Mohan Singh Nagar, Toansa District SBS Nagar (Nawanshahr) Punjab 144 533, India

Centrient Pharmaceuticals

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCentrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

Rosuvastatin calcium

Registrant Name : Aging Life Science Co., Ltd.

Registration Date : 2020-07-07

Registration Number : 20200707-209-J-677

Manufacturer Name : Centrient Pharmaceuticals In...

Manufacturer Address : Bhai Mohan Singh Nagar, Toansa District SBS Nagar (Nawanshahr) Punjab 144 533, India

Centrient Pharmaceuticals

03

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Rosuvastatin calcium

Registrant Name : Ace Biopharm Co., Ltd.

Registration Date : 2023-11-22

Registration Number : 20200107-209-J-320(7)

Manufacturer Name : Biocon Limited

Manufacturer Address : Plot No. 213 -215 and 216/B Phase - II, IDA, Pashamylaram Sangareddy District - 502 3...

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04

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Rosuvastatin calcium

Registrant Name : Pampia Co., Ltd.

Registration Date : 2023-04-07

Registration Number : 20230407-209-J-1470

Manufacturer Name : Cadchem Laboratories Limited

Manufacturer Address : Village Jaula Khurd, Tehsil DeraBassi, District Sahibzada Ajit Singh Nagar, Punjab, I...

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05

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Rosuvastatin calcium

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2023-12-11

Registration Number : 20190115-209-J-121(2)

Manufacturer Name : CTX Life Sciences Pvt. Ltd.

Manufacturer Address : Block No. 251/P, 252/P, 253 to 255, 256/P, 258/P, 276/P, 277, 278/P, 279 to 282, 283/...

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06

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Rosuvastatin calcium

Registrant Name : KR Pharm Co., Ltd.

Registration Date : 2023-07-11

Registration Number : 20191219-209-J-510(4)

Manufacturer Name : Ruyuan HEC Pharm Co., Ltd.

Manufacturer Address : Xiaba Development Zone, Ruyuan County, Shaoguan City, 512721, Guangdong Province, Chi...

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07

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Rosuvastatin calcium (micronized)

Registrant Name : Pami Future Co., Ltd.

Registration Date : 2024-06-28

Registration Number : 20240628-209-J-1660

Manufacturer Name : Ruyuan Hec Pharma Co., Ltd.

Manufacturer Address : Xiaba Development Zone, Ruyuan Country, Shanoguan City, Guangdong Province, 512721 Ch...

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08

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Rosuvastatin Calcium

Registrant Name : Lee Sung International Co., Ltd.

Registration Date : 2024-07-15

Registration Number : 20240715-209-J-1659

Manufacturer Name : Nosch Labs Private Limited (...

Manufacturer Address : Sy. No.14, Gaddapotharam Village, IDA, Kazipally, Jinnaram Mandal, Sangareddy Distric...

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09

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Rosuvastatin calcium

Registrant Name : Myungmoon Bio Co., Ltd.

Registration Date : 2024-08-01

Registration Number : 20240801-209-J-1673

Manufacturer Name : Myungmoon Bio Co., Ltd.

Manufacturer Address : 28, Yakjakgongdan 2-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do (10th building and ot...

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10

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Rosuvastatin calcium

Registrant Name : KR Pharm Co., Ltd.

Registration Date : 2023-05-17

Registration Number : 20221130-209-J-1235(1)

Manufacturer Name : Shaoxing Jingxin Pharmaceuti...

Manufacturer Address : No.31, Weisan Road, Hangzhou Bay Shangyu Economic and Technological Development Area,...

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