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

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$ API Ref.Price (USD/KG) : 219Xls
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01 7Dr. Reddy's Laboratories Limited

02 1Dr.Reddy's Laboratories Limited

03 6Centrient Pharmaceuticals India Private Limited

04 2Asia Chemical Industries Ltd. Teva-Tech Site

05 5Biocon Limited(Site-2)

06 1Chong Kun Dang Co., Ltd. @Dr. Reddy's Laboratories Limited

07 1Estifarm Co., Ltd.

08 1Gyeongbo Pharmaceutical Co., Ltd@[Crude Atorvastatin Manufacturer]Zhejiang Lepu Pharmaceutical Co., Ltd.

09 1Hanmi Precision Chemical Co., Ltd.

10 2Hanseochem Co., Ltd.

11 3Hetero Labs Limited (Unit-IX)

12 1Hetero Labs Limited(Unit-IX)

13 1Ind-Swift Laboratories Limited

14 1Kookjeon Pharmaceutical Co., Ltd.@[Raw product manufacturer]Reine Lifescience

15 1Korea Biochem Pharmaceutical Co., Ltd. @[Starting material (atorvastatin tert-butyl ester) manufacturer] Zheijang LEPU pharmaceutical Co., Ltd.

16 2Kyungbo Pharmaceutical Co., Ltd.

17 1Kyungbo Pharmaceutical Co., Ltd.@Heibei Baiqi Pharmaceutical Co., Ltd.@Anhui Heryi Pharmaceutical Co., Ltd

18 1Lek Pharmaceuticals dd

19 1Lek Pharmaceutics dd

20 3MSN Pharmachem Private Limited

21 1MSN Pharmachem Pvt. Ltd

22 1MYLAN LABORATORIES LIMITED

23 4Morepen Laboratories Limited

24 1Mylan Laboratories Limited

25 1Mylan Laboratories Limited (Unit-8)

26 1Myungmoon Bio Co., Ltd.

27 1Pfizer Ireland Pharmaceuticals

28 1Pharmacostec Co., Ltd.

29 1ST Pharm Co., Ltd. @ Starting material (Atorvastatin T-butyl ester 1) manufacturer ① Whejiang Hongyuan Pharmaceutical co.ltd @ Starting material (Atorvastatin T-butyl ester 1) manufacturer ② Changzhou Pharmaceutical Factory

30 1Samjin Pharmaceutical Co., Ltd.

31 1Shin Poong Pharmaceutical Co., Ltd.

32 1Sun Pharmaceutical Industries Ltd.

33 3Synthimed Labs Private Limited

34 1Teva API India Pvt. Ltd

35 1Tianish Laboratories Private Limited (Unit-9)

36 1Upjohn Manufacturing Ireland Unlimited

37 1Upjohn Manufacturing Ireland Unlimited Company

38 1Yuhan Chemical Co., Ltd.

39 1Yuil Farm Tech Co., Ltd.

40 1Zhejiang Haisen Pharmaceutical Co., Ltd

41 1Zhejiang Jiangbei Pharmaceutical Co., Ltd.

42 2Zhejiang Jiangbei Pharmaceutical Co.,Ltd.

43 12Zhejiang LEPU Pharmaceutical Co., Ltd.

44 1Zhejiang Lepu Pharmaceutical Co., Ltd

45 2Zhejiang Lepu Pharmaceutical Co., Ltd.

46 1[Second Law Raw Material Manufacturer] Chromo Laboratories India Private Limited@(주)엔지케명과학@[Starting Material Manufacturer] Xinxiang Pharmaceutical Co., Ltd.

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

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

Atorvastatin calcium trihydrate

Registrant Name : Hwail Pharmaceutical Co., Ltd.

Registration Date : 2024-05-01

Registration Number : 20230331-132-H-410-49(1)

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

Manufacturer Address : CTO-SEZ Process Unit-01 Sector No’s. 28 to 34, 36 to 37, 40, 50 to 53 & 03, Survey ...

Dr Reddy Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

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

Atorvastatin calcium

Registrant Name : Huseeed Co., Ltd.

Registration Date : 2021-09-03

Registration Number : 20161124-132-H-310-40(6)

Manufacturer Name : Centrient Pharmaceuticals In...

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

Centrient Pharmaceuticals

03

  • fda
  • EDQM
  • WHO-GMP

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

Atorvastatin calcium

Registrant Name : Sangjin Corporation

Registration Date : 2011-02-25

Registration Number : 20110225-132-H-87-07

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

Manufacturer Address : Chemical Technical Operations-Unit-II Plot No. 1, 75A, 75B, 105, 110, 111 & 112 Sri V...

Dr Reddy Company Banner

04

  • fda
  • EDQM
  • WHO-GMP

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

Atorvastatin calcium

Registrant Name : Kyungdong Pharmaceutical Co., Ltd.

Registration Date : 2011-06-30

Registration Number : 20110225-132-H-87-07(2)

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

Manufacturer Address : Chemical Technical Operations-Unit-II Plot No. 1, 75A, 75B, 105, 110, 111 & 112 Sri V...

Dr Reddy Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

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

Atorvastatin calcium

Registrant Name : Hwail Pharmaceutical Co., Ltd.

Registration Date : 2011-06-15

Registration Number : 20110225-132-H-87-07(1)

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

Manufacturer Address : Chemical Technical Operations-Unit-II Plot No. 1, 75A, 75B, 105, 110, 111 & 112 Sri V...

Dr Reddy Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

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

Atorvastatin calcium

Registrant Name : Huseeed Co., Ltd.

Registration Date : 2022-07-13

Registration Number : 20110225-132-H-87-07(5)

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

Manufacturer Address : Chemical Technical Operations-Unit-II Plot No. 1, 75A, 75B, 105, 110, 111 & 112 Sri V...

Dr Reddy Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

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

Atorvastatin calcium

Registrant Name : Sangjin Corporation

Registration Date : 2011-04-14

Registration Number : 20110414-132-H-124-08

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

Manufacturer Address : Chemical Technical Operations-Unit-II Plot No. 1, 75A, 75B, 105, 110, 111 & 112 Sri V...

Dr Reddy Company Banner

08

  • fda
  • EDQM
  • WHO-GMP

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

Atorvastatin calcium trihydrate

Registrant Name : Sangjin Corporation

Registration Date : 2023-03-31

Registration Number : 20230331-132-H-410-49

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

Manufacturer Address : CTO-SEZ Process Unit-01, Sector No's. 28 to 34, 36 to 37, 40, 50 to 53 & 03, Survey N...

Dr Reddy Company Banner

09

  • fda
  • EDQM
  • WHO-GMP

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

Atorvastatin calcium

Registrant Name : Hwail Pharmaceutical Co., Ltd.

Registration Date : 2011-12-02

Registration Number : 20110414-132-H-124-08(2)

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

Manufacturer Address : Chemical Technical Operations-Unit-II Plot No. 1, 75A, 75B, 105, 110, 111 & 112 Sri V...

Dr Reddy Company Banner

10

  • fda
  • EDQM
  • WHO-GMP

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

Atorvastatin calcium

Registrant Name : Daeshin Pharmaceutical Co., Ltd.

Registration Date : 2019-07-19

Registration Number : 20161124-132-H-310-40(5)

Manufacturer Name : Centrient Pharmaceuticals In...

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

Centrient Pharmaceuticals