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Egis Atorvastatin - Dapagliflozin Egis Atorvastatin - Dapagliflozin

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

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01 Dr. Reddy's Laboratories Limited (7)

02 Centrient Pharmaceuticals India Private Limited (6)

03 @Heibei Baiqi Pharmaceutical Co., Ltd.@Anhui Heryi Pharmaceutical Co., Ltd (1)

04 @Zhejiang Lepu Pharmaceutical Co., Ltd (1)

05 Asia Chemical Industries Ltd. Teva-Tech Site (2)

06 Biocon Limited (Site-2) (5)

07 Chong Kun Dang Bio Co., Ltd.@[Jopum Manufacturing Co., Ltd.]_x000D_ Hebei Baiqi Pharmaceutical Co., Ltd_x000D_ (1)

08 Chong Kun Dang Co., Ltd. @Dr. Reddy's Laboratories Limited (1)

09 Hana Pharmaceutical Co., Ltd. (1)

10 Hanmi Fine Chemical Co., Ltd. (1)

11 Hanseochem Co., Ltd. (2)

12 Hetero Labs Limited (Unit-IX) (4)

13 Ildong Pharmaceutical Co., Ltd. (2)

14 Ind-Swift Laboratories Limited (4)

15 Kookjeon Pharmaceutical Co., Ltd. @[Jopum Manufacturer] Reine Lifescience (1)

16 Korea Biochem Pharmaceutical Co., Ltd. @[Manufacturer of starting material (atorvastatin tinterbutyl ester)] Zheijang LEPU pharmaceutical Co., Ltd. (1)

17 Kyungbo Pharmaceutical Co., Ltd. (2)

18 Lek Pharmaceuticals d.d. (1)

19 Lek Pharmaceuticlas d.d. (1)

20 MSN Pharmachem Private Limited (3)

21 MSN Pharmachem Pvt. Ltd (1)

22 MYLAN LABORATORIES LIMITED (2)

23 Morepen Laboratories Limited (4)

24 Mylan Laboratories Limited (2)

25 Mylan Laboratories Limited (Unit-8) (1)

26 Myungmoon Bio Co., Ltd. (1)

27 Pfizer Ireland Pharmaceuticals (1)

28 Pharmacotech Co., Ltd. (1)

29 ST Pharm Co., Ltd. (1)

30 ST Pharm Co., Ltd.@Manufacturer of starting material (atorvastatin T-butyl ester 1) ① Whejiang Hongyuan Pharmaceutical co.ltd@Manufacturer of starting material (atorvastatin T-butyl ester 1) ② Changzhou Pharmaceutical Factory (1)

31 Samjin Pharmaceutical Co., Ltd. (1)

32 Shinpoong Pharmaceutical Co., Ltd. (1)

33 Sun Pharmaceutical Industries Ltd. (1)

34 Teva API India Pvt. Ltd (1)

35 Upjohn Manufacturing Ireland Unlimited (1)

36 Upjohn Manufacturing Ireland Unlimited Company (1)

37 Yuhan Chemical Co., Ltd. (1)

38 Yuil Farm Tech Co., Ltd. (1)

39 Zhejiang Haisen Pharmaceutical Co., Ltd (1)

40 Zhejiang Jiangbei Pharmaceutical Co., Ltd. (1)

41 Zhejiang Jiangbei Pharmaceutical Co.,Ltd. (2)

42 Zhejiang LEPU Pharmaceutical Co., Ltd. (11)

43 Zhejiang Lepu Pharmaceutical Co., Ltd. (2)

44 Zhejiang Lepu Pharmaceutical Co., Ltd. @[Atorvastatin Crude Manufacturer] Zhejiang Lepu Pharmaceutical Co., Ltd. (1)

45 [2nd law crude product manufacturer] Chromo Laboratories India Private Limited@NGChem Life Science Co., Ltd.@[Starting material manufacturer] Xinxiang Pharmaceutical Co., Ltd. (1)

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01 Ace Biopharm Co., Ltd. (2)

02 Agerson Bio Co., Ltd. (2)

03 Aging Life Science Co., Ltd. (1)

04 Beatrice Korea Co., Ltd. (2)

05 Celltrion Pharmaceutical Co., Ltd. (1)

06 Chemipharm Co., Ltd. (2)

07 Chong Kun Dang Bio Co., Ltd. (1)

08 Chong Kun Dang Co., Ltd. (1)

09 Daebong LS Co., Ltd. (1)

10 Daesin Pharmaceutical Co., Ltd. (2)

11 ENGCHEM Life Science Co., Ltd. (1)

12 EQ Bio Co., Ltd. (1)

13 Farmirae Co., Ltd. (1)

14 HK Innoen Co., Ltd. (1)

15 Hana Pharmaceutical Co., Ltd. (1)

16 Hanmi Fine Chemical Co., Ltd. (1)

17 Hanmi Pharmaceutical Co., Ltd. (1)

18 Hanseochem Co., Ltd. (2)

19 Hanyoung Farm Co., Ltd. (3)

20 Hiple Co., Ltd. (1)

21 Huseed Co., Ltd. (2)

22 Hwail Pharmaceutical Co., Ltd. (3)

23 IMCD Korea Co., Ltd. (2)

24 Iksoo Pharmaceutical Co., Ltd. (1)

25 Ildong Pharmaceutical Co., Ltd. (2)

26 Inist Farm Co., Ltd. (1)

27 KR Farm Co., Ltd. (1)

28 Kookjeon Pharmaceutical Co., Ltd. (3)

29 Korea Biochem Pharmaceutical Co., Ltd. (1)

30 Kyungbo Pharmaceutical Co., Ltd. (5)

31 Kyungdong Pharmaceutical Co., Ltd. (2)

32 Leesung International Co., Ltd. (1)

33 Masung LS Co., Ltd. (1)

34 Mpeak Korea Co., Ltd. (1)

35 Myungmoon Bio Co., Ltd. (1)

36 Neo Co., Ltd. (1)

37 Otran Farm Korea Co., Ltd. (1)

38 Pharma Solution Co., Ltd. (2)

39 Pharmacotech Co., Ltd. (1)

40 Pharmapia Co., Ltd. (5)

41 SG Biochem Co., Ltd. (3)

42 ST Pharm Co., Ltd. (2)

43 Saehan Pharmaceutical Co., Ltd. (1)

44 Samjin Pharmaceutical Co., Ltd. (1)

45 Samo Pharmaceutical Co., Ltd. (2)

46 Sandoz Korea Co., Ltd. (2)

47 Sangjin Trading Co., Ltd. (3)

48 Seil Pharmaceutical Co., Ltd. (1)

49 Seongui Bio Co., Ltd. (1)

50 Shinpoong Pharmaceutical Co., Ltd. (1)

51 Sungjin Exim Co., Ltd. (1)

52 Sungwoo Chemical Co., Ltd. (1)

53 Toru Co., Ltd. (1)

54 Youngil Pharmaceutical Co., Ltd. (1)

55 Yuhan Chemical Co., Ltd. (1)

56 Yuhan Corporation (1)

57 Yuil Farm Tech Co., Ltd. (1)

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01 Atorvastatin Calcium (75)

02 Atorvastatin Calcium Trihydrate (4)

03 Atorvastatin calcium hydrate (9)

04 Atorvastatin strontium salt (1)

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01 China (17)

02 India (30)

03 Israel (3)

04 Japan (1)

05 Netherlands (6)

06 Singapore (1)

07 Slovenia (2)

08 South Korea (21)

09 U.S.A (8)

Sangjin Trading Co., Ltd.
2023-03-31
20230331-132-H-410-49
Dr. Reddy's Laboratories ...
India
CTO-SEZ Process Unit-01, ...
Huseed Co., Ltd.
2021-09-03
20161124-132-H-310-40(6)
Centrient Pharmaceuticals...
India
Bhai Mohan Singh Nagar, T...
Centrient Pharmaceuticals

CPhI Japan

Not Confirmed

envelop Contact Supplier
Sangjin Trading Co., Ltd.
2011-04-14
20110414-132-H-124-08
Dr. Reddy's Laboratories ...
India
Chemical Technical Operat...
Hwail Pharmaceutical Co., Ltd.
2011-12-02
20110414-132-H-124-08(2)
Dr. Reddy's Laboratories ...
India
Chemical Technical Operat...
Kyungdong Pharmaceutical Co., Ltd.
2011-06-30
20110225-132-H-87-07(2)
Dr. Reddy's Laboratories ...
India
Chemical Technical Operat...
Sangjin Trading Co., Ltd.
2011-02-25
20110225-132-H-87-07
Dr. Reddy's Laboratories ...
India
Chemical Technical Operat...
Huseed Co., Ltd.
2022-07-13
20110225-132-H-87-07(5)
Dr. Reddy's Laboratories ...
India
Chemical Technical Operat...
Hwail Pharmaceutical Co., Ltd.
2011-06-15
20110225-132-H-87-07(1)
Dr. Reddy's Laboratories ...
India
Chemical Technical Operat...
IMCD Korea Co., Ltd.
2018-05-04
20161124-132-H-310-40(4)
Centrient Pharmaceuticals...
India
Bhai Mohan Singh Nagar, T...
Centrient Pharmaceuticals

CPhI Japan

Not Confirmed

envelop Contact Supplier
Daesin Pharmaceutical Co., Ltd.
2019-07-19
20161124-132-H-310-40(5)
Centrient Pharmaceuticals...
India
Bhai Mohan Singh Nagar, T...
Centrient Pharmaceuticals

CPhI Japan

Not Confirmed

envelop Contact Supplier

Looking for 134523-00-5 / Atorvastatin API manufacturers, exporters & distributors?

Atorvastatin manufacturers, exporters & distributors 1

12

PharmaCompass offers a list of Atorvastatin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Atorvastatin manufacturer or Atorvastatin supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Atorvastatin manufacturer or Atorvastatin supplier.

PharmaCompass also assists you with knowing the Atorvastatin API Price utilized in the formulation of products. Atorvastatin API Price is not always fixed or binding as the Atorvastatin Price is obtained through a variety of data sources. The Atorvastatin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Atorvastatin

Synonyms

134523-00-5, Cardyl, Lipitor, 110862-48-1, Torvast, Atorvastatin calcium

Cas Number

134523-00-5

Unique Ingredient Identifier (UNII)

A0JWA85V8F

About Atorvastatin

A pyrrole and heptanoic acid derivative, HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITOR (statin), and ANTICHOLESTEREMIC AGENT that is used to reduce serum levels of LDL-CHOLESTEROL; APOLIPOPROTEIN B; and TRIGLYCERIDES. It is used to increase serum levels of HDL-CHOLESTEROL in the treatment of HYPERLIPIDEMIAS, and for the prevention of CARDIOVASCULAR DISEASES in patients with multiple risk factors.

Atorvastatin Manufacturers

A Atorvastatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Atorvastatin, including repackagers and relabelers. The FDA regulates Atorvastatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Atorvastatin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Atorvastatin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Atorvastatin Suppliers

A Atorvastatin supplier is an individual or a company that provides Atorvastatin active pharmaceutical ingredient (API) or Atorvastatin finished formulations upon request. The Atorvastatin suppliers may include Atorvastatin API manufacturers, exporters, distributors and traders.

click here to find a list of Atorvastatin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Atorvastatin KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Atorvastatin Drug Master File in Korea (Atorvastatin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Atorvastatin. The MFDS reviews the Atorvastatin KDMF as part of the drug registration process and uses the information provided in the Atorvastatin KDMF to evaluate the safety and efficacy of the drug.

After submitting a Atorvastatin KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Atorvastatin API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Atorvastatin suppliers with KDMF on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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