Egis Atorvastatin - Dapagliflozin Egis Atorvastatin - Dapagliflozin

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List of Korea Drug Master Files (KDMF) for Atorvastatin Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Sangjin Trading Co., Ltd.
2011-04-14
20110414-132-H-124-08
Dr. Reddy's Laboratories ...
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Hwail Pharmaceutical Co., Ltd.
2011-12-02
20110414-132-H-124-08(2)
Dr. Reddy's Laboratories ...
India
Chemical Technical Operat...
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Kyungdong Pharmaceutical Co., Ltd.
2011-06-30
20110225-132-H-87-07(2)
Dr. Reddy's Laboratories ...
India
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Sangjin Trading Co., Ltd.
2011-02-25
20110225-132-H-87-07
Dr. Reddy's Laboratories ...
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Huseed Co., Ltd.
2022-07-13
20110225-132-H-87-07(5)
Dr. Reddy's Laboratories ...
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Hwail Pharmaceutical Co., Ltd.
2011-06-15
20110225-132-H-87-07(1)
Dr. Reddy's Laboratories ...
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Sangjin Trading Co., Ltd.
2023-03-31
20230331-132-H-410-49
Dr. Reddy's Laboratories ...
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SG Biochem Co., Ltd.
2017-03-23
20161124-132-H-310-40(1)
Centrient Pharmaceuticals...
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Bhai Mohan Singh Nagar, T...
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IMCD Korea Co., Ltd.
2018-05-04
20161124-132-H-310-40(4)
Centrient Pharmaceuticals...
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Bhai Mohan Singh Nagar, T...
Centrient Pharmaceuticals

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Hanyoung Farm Co., Ltd.
2017-11-17
20161124-132-H-310-40(3)
Centrient Pharmaceuticals...
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Bhai Mohan Singh Nagar, T...
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Aging Life Science Co., Ltd.
2016-11-24
20161124-132-H-310-40
Centrient Pharmaceuticals...
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Bhai Mohan Singh Nagar, T...
Centrient Pharmaceuticals

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Daesin Pharmaceutical Co., Ltd.
2019-07-19
20161124-132-H-310-40(5)
Centrient Pharmaceuticals...
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Bhai Mohan Singh Nagar, T...
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Huseed Co., Ltd.
2021-09-03
20161124-132-H-310-40(6)
Centrient Pharmaceuticals...
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Seongui Bio Co., Ltd.
2016-04-29
20160429-132-H-300-36
Biocon Limited (Site-2)
India
Biocon Special Economic z...
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Hanmi Pharmaceutical Co., Ltd.
2017-02-09
20160429-132-H-300-36(1)
Biocon Limited (Site-2)
India
Biocon Special Economic z...
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Sungwoo Chemical Co., Ltd.
2019-03-14
20160429-132-H-300-36(4)
Biocon Limited (Site-2)
India
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Pharma Solution Co., Ltd.
2018-02-08
20160429-132-H-300-36(3)
Biocon Limited (Site-2)
India
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Pharmapia Co., Ltd.
2019-05-24
20160429-132-H-300-36(5)
Biocon Limited (Site-2)
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Chong Kun Dang Co., Ltd.
2022-06-27
20220627-132-H-400-48
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797-48 Manghyang-ro, Seon...
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Hanseochem Co., Ltd.
2016-08-18
20160818-132-H-317-38
Hanseochem Co., Ltd.
South Korea
41 Poseunggongdan-ro, Pos...
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Hanseochem Co., Ltd.
2018-02-08
20180208-132-H-334-43
Hanseochem Co., Ltd.
South Korea
41 Poseunggongdan-ro, Pos...
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Neo Co., Ltd.
2023-07-19
20200318-132-H-354-44(3)
Hetero Labs Limited (Unit...
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Leesung International Co., Ltd.
2020-03-18
20200318-132-H-354-44
Hetero Labs Limited (Unit...
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Pharma Solution Co., Ltd.
2022-12-14
20200318-132-H-354-44(2)
Hetero Labs Limited (Unit...
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Agerson Bio Co., Ltd.
2022-02-22
20200318-132-H-354-44(1)
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Youngil Pharmaceutical Co., Ltd.
2019-04-09
20130204-132-H-237-21(3)
Ind-Swift Laboratories Li...
India
Village Bhagwanpur, Barwa...
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Hanyoung Farm Co., Ltd.
2023-10-19
20130204-132-H-237-21(4)
Ind-Swift Laboratories Li...
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Village Bhagwanpur, Barwa...
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Kookjeon Pharmaceutical Co., Ltd.
2017-03-17
20170317-132-H-325-42
Kookjeon Pharmaceutical C...
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8 Balangongdan-ro, Hyangn...
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Inist Farm Co., Ltd.
2016-04-04
20150824-132-H-281-31(1)
Morepen Laboratories Limi...
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(Morepen Village)Vill. Ma...
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Sandoz Korea Co., Ltd.
2020-08-27
20200827-132-H-370-46
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Chemipharm Co., Ltd.
2021-03-25
20150824-132-H-281-31(3)
Morepen Laboratories Limi...
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(Morepen Village)Vill. Ma...
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EQ Bio Co., Ltd.
2024-02-01
20150114-132-H-269-29(2)
MSN Pharmachem Private Li...
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Plot. No.212/A,B,C,D,Phas...
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HK Innoen Co., Ltd.
2019-09-24
20110110-132-H-57-04(1)
Upjohn Manufacturing Irel...
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Little Island, Co, Cork, ...
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Pharmacotech Co., Ltd.
2017-02-15
20170215-132-H-324-41
Pharmacotech Co., Ltd.
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Block 35-2, Balan Regiona...
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Samjin Pharmaceutical Co., Ltd.
2016-11-24
20161124-132-H-318-39
Samjin Pharmaceutical Co....
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156 Osongsaengmyeong 6-ro...
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Ace Biopharm Co., Ltd.
2019-04-11
20120525-132-H-208-17(2)
Mylan Laboratories Limite...
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Unit-8, G.Chodavaram, Poo...
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Toru Co., Ltd.
2019-12-19
20120525-132-H-208-17(3)
MYLAN LABORATORIES LIMITE...
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(Unit-8) G. Chodavaram, P...
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Yuhan Chemical Co., Ltd.
2023-06-13
20230613-132-H-411-50
Yuhan Chemical Co., Ltd.
South Korea
162 Cheongwonsandan 8-gil...
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Pharmapia Co., Ltd.
2020-07-09
20200709-132-H-356-45
Zhejiang Haisen Pharmaceu...
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Xiangtan Village, Liushi ...
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Agerson Bio Co., Ltd.
2024-02-01
20210128-132-H-383-47(A)
Zhejiang Jiangbei Pharmac...
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Dongdai Zhang'an Street, ...
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Mpeak Korea Co., Ltd.
2021-01-28
20210128-132-H-383-47
Zhejiang Jiangbei Pharmac...
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Dongdai Zhang'an Street J...
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SG Biochem Co., Ltd.
2021-06-22
20210128-132-H-383-47(1)
Zhejiang Jiangbei Pharmac...
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Dongdai Zhang'an Street J...
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Otran Farm Korea Co., Ltd.
2021-08-17
20130618-132-H-238-23(15)
Zhejiang LEPU Pharmaceuti...
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No.29, Binhai Road, Jiaoj...
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Ace Biopharm Co., Ltd.
2016-04-19
20130618-132-H-238-23(7)
Zhejiang LEPU Pharmaceuti...
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No.29, Binhai Road, Jiaoj...
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Daesin Pharmaceutical Co., Ltd.
2016-03-15
20130618-132-H-238-23(6)
Zhejiang LEPU Pharmaceuti...
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Masung LS Co., Ltd.
2020-08-21
20130618-132-H-238-23(13)
Zhejiang LEPU Pharmaceuti...
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Kyungdong Pharmaceutical Co., Ltd.
2022-11-10
20130618-132-H-238-23(16)
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Hiple Co., Ltd.
2021-03-23
20130618-132-H-238-23(14)
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Saehan Pharmaceutical Co., Ltd.
2020-07-21
20130618-132-H-238-23(12)
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Daebong LS Co., Ltd.
2016-10-27
20130618-132-H-238-23(10)
Zhejiang Lepu Pharmaceuti...
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No.259, Binhai Road, Yant...
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  • TABLET;ORAL - EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 10MG BASE
  • TABLET;ORAL - EQ 20MG BASE
  • TABLET;ORAL - EQ 40MG BASE
  • TABLET;ORAL - EQ 80MG BASE
  • TABLET;ORAL - EQ 10MG BASE;EQ 10MG BASE
  • TABLET;ORAL - EQ 10MG BASE;EQ 20MG BASE
  • TABLET;ORAL - EQ 10MG BASE;EQ 40MG BASE
  • TABLET;ORAL - EQ 10MG BASE;EQ 80MG BASE
  • TABLET;ORAL - EQ 2.5MG BASE;EQ 10MG BASE
  • TABLET;ORAL - EQ 2.5MG BASE;EQ 20MG BASE
  • TABLET;ORAL - EQ 2.5MG BASE;EQ 40MG BASE
  • TABLET;ORAL - EQ 5MG BASE;EQ 10MG BASE
  • TABLET;ORAL - EQ 5MG BASE;EQ 20MG BASE
  • TABLET;ORAL - EQ 5MG BASE;EQ 40MG BASE
  • TABLET;ORAL - EQ 5MG BASE;EQ 80MG BASE

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

Atorvastatin manufacturers, exporters & distributors 1

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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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