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

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01 Neuland Laboratories Limited (2)

02 Teva API India Pvt. Ltd (1)

03 Aragen Life Sciences Private Limited (1)

04 Aragen Life Sciences Pvt. Ltd (1)

05 Chong Kun Dang @Ind-Swift Laboratories Limited (1)

06 Glenmark Life Sciences Limited (8)

07 Glenmark Life Sciences Limited. (1)

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

09 Hanseochem Co., Ltd. (1)

10 Hetero Labs Limited (1)

11 Hetero Labs Limited (Unit-1) (2)

12 Ind-Swift Laboratories Limited (15)

13 Ind-Swift Laboratories Limited_x000D_ (2)

14 Inist ST Co., Ltd.@Zhejiang Tianyu Pharmaceutical Co., Ltd. (1)

15 Korea Biochem Pharmaceutical Co., Ltd. @Zhejiang Tianyu Pharmaceutical Co., Ltd. (1)

16 Lupine Limited (4)

17 MSD International GmbH (Singapore Branch) (1)

18 MSN Laboratories PVT.LTD (7)

19 MSN Laboratories Private Limited (4)

20 Nantong Chanyoo Pharmatech Co., Ltd (1)

21 Yuhan Chemical Co., Ltd.@Hanseochem Co., Ltd. (1)

22 Zhejiang Tianyu Pharmaceutical Co., Ltd (1)

23 Zhejiang Tianyu Pharmaceutical Co., Ltd. (1)

24 Zhejiang Tianyu Pharmaceutical Co., Ltd.@[Zhejiang Tianyu Pharmaceutical Co., Ltd.] (1)

25 Zhejiang Tianyu Pharmaceutical Co., Ltd@Kyungdong Pharmaceutical Co., Ltd. (1)

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01 Ace Biopharm Co., Ltd. (1)

02 Agerson Bio Co., Ltd. (3)

03 Aging Life Science Co., Ltd. (2)

04 Aju Pharmaceutical Co., Ltd. (1)

05 Alvogen Korea Co., Ltd. (2)

06 Boryeong Co., Ltd. (1)

07 Chong Kun Dang Co., Ltd. (2)

08 Daebong LS Co., Ltd. (1)

09 Daehan New Farm Co., Ltd. (1)

10 Daewon Pharmaceutical Co., Ltd. (1)

11 Daewoong Pharmaceutical Co., Ltd. (2)

12 Donggu Bio Pharmaceutical Co., Ltd. (1)

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

14 Hanmi Pharmaceutical Co., Ltd. (1)

15 Hanseochem Co., Ltd. (1)

16 Hansol Pharma Co., Ltd. (1)

17 Hanyoung Farm Co., Ltd. (2)

18 Hiple Co., Ltd. (1)

19 Huseed Co., Ltd. (1)

20 Hwail Pharmaceutical Co., Ltd. (2)

21 IMCD Korea Co., Ltd. (1)

22 Inist ST Co., Ltd. (1)

23 Kookjeon Pharmaceutical Co., Ltd. (2)

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

25 Korea Organon Co., Ltd. (1)

26 Korea United Pharmaceutical Co., Ltd. (1)

27 Kyungbo Pharmaceutical Co., Ltd. (1)

28 Kyungdong Pharmaceutical Co., Ltd. (2)

29 Leaders Bio Co., Ltd. (1)

30 Leesung International Co., Ltd. (1)

31 Masung LS Co., Ltd. (1)

32 Mpeak Korea Co., Ltd. (1)

33 Nexnus Co., Ltd. (2)

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

35 Pharma Solution Co., Ltd. (2)

36 Pharmapia Co., Ltd. (3)

37 SG Biochem Co., Ltd. (2)

38 Samo Pharmaceutical Co., Ltd. (2)

39 Sangjin Trading Co., Ltd. (1)

40 Seongui Bio Co., Ltd. (1)

41 Sungjin Exim Co., Ltd. (1)

42 Sungwoo Chemical Co., Ltd. (1)

43 UNUST Co., Ltd. (1)

44 Withers Pharmaceutical Co., Ltd. (1)

45 Yuhan Chemical Co., Ltd. (1)

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01 Ezetimibe (micronized) (3)

02 ezetimibe (58)

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01 China (3)

02 India (46)

03 Israel (1)

04 South Korea (10)

05 U.S.A (1)

Aging Life Science Co., Ltd.
2019-04-11
Number 4579-6-ND(1)
Neuland Laboratories Limi...
India
Plot No.s 92, 93, 94, 257...
Sungwoo Chemical Co., Ltd.
2015-12-01
Number 4579-6-ND
Neuland Laboratories Limi...
India
Unit-II, Plot Nos.: 92-94...
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Samo Pharmaceutical Co., Ltd.
2010-12-15
711-8-ND
Teva API India Pvt. Ltd
India
Plot Nos, A-2, A-2/1, A-2...
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Agerson Bio Co., Ltd.
2023-04-07
Number 946-2-ND
Aragen Life Sciences Priv...
India
28A, IDA., Nacharam, Hyde...
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Huseed Co., Ltd.
2023-02-13
Number 5217-1-ND(17)
Ind-Swift Laboratories Li...
India
Village Bhagwanpur, Barwa...
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Agerson Bio Co., Ltd.
2022-08-05
Number 5217-1-ND(16)
Ind-Swift Laboratories Li...
India
Village Bhagwanpur, Barwa...
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Alvogen Korea Co., Ltd.
2023-12-21
Number 173-31-ND(3)
MSN Laboratories Private ...
India
Sy. No. 317, 320, 321, 32...
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Yuhan Chemical Co., Ltd.
2022-08-11
1791-10-ND
Yuhan Chemical Co., Ltd.@...
South Korea
#402, 5-ba, Sihwa Industr...
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Ace Biopharm Co., Ltd.
2024-01-04
Number 695-9-ND(1)
Zhejiang Tianyu Pharmaceu...
China
No.15, Donghai 5th Avenue...
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Otran Farm Korea Co., Ltd.
2022-06-29
Number 695-9-ND
Zhejiang Tianyu Pharmaceu...
China
No.15, Donghai 5th Avenue...
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Looking for 163222-33-1 / Ezetimibe API manufacturers, exporters & distributors?

Ezetimibe manufacturers, exporters & distributors 1

15

PharmaCompass offers a list of Ezetimibe 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 Ezetimibe manufacturer or Ezetimibe supplier for your needs.

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

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

API | Excipient name

Ezetimibe

Synonyms

163222-33-1, Zetia, Ezetrol, Ezedoc, Sch 58235, Sch58235

Cas Number

163222-33-1

Unique Ingredient Identifier (UNII)

EOR26LQQ24

About Ezetimibe

An azetidine derivative and ANTICHOLESTEREMIC AGENT that inhibits intestinal STEROL absorption. It is used to reduce total CHOLESTEROL; LDL CHOLESTEROL, and APOLIPOPROTEINS B in the treatment of HYPERLIPIDEMIAS.

Zetia Manufacturers

A Zetia manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zetia, including repackagers and relabelers. The FDA regulates Zetia manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zetia 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 Zetia manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Zetia Suppliers

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

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

Zetia KDMF

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

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

After submitting a Zetia 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 Zetia API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Zetia 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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