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

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01 Ami Lifesciences Private Limited (2)

02 Boryeong Co., Ltd. (2)

03 Boryeong Co., Ltd. @Boryeong Co., Ltd. (1)

04 KIMIA BIOSCIENCES LIMITED (1)

05 Kukjeon Pharmaceutical Co., Ltd.@[Starting Material Manufacturer]Aurore Pharmaceuticals Private Limited (Unit-1) (1)

06 MFC Co., Ltd. @KPX Life Science Co., Ltd. (1)

07 Zydus Lifesciences Limited (2)

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01 Ace Biopharm Co., Ltd. (1)

02 Boryeong Co., Ltd. (3)

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

04 FarmChem Service Co., Ltd. (1)

05 Kookjeon Pharmaceutical Co., Ltd. (1)

06 MFC Co., Ltd. (1)

07 Mpeak Korea Co., Ltd. (1)

08 Narsha Farm Co., Ltd. (1)

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01 Fimasartan Potassium Trihydrate (9)

02 Fimasartantromethamine saline hydrate (1)

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01 India (5)

02 South Korea (5)

FarmChem Service Co., Ltd.
2023-02-22
Number 423-1-ND(1)
Ami Lifesciences Private ...
India
Block No. 82/B, ECP Road ...
Narsha Farm Co., Ltd.
2022-04-19
Number 423-1-ND
Ami Lifesciences Private ...
India
Block No. 82/B, ECP Road ...
URL Supplier Web Content
Boryeong Co., Ltd.
2016-04-20
1689-2-ND
Boryeong Co., Ltd.
South Korea
107, 109, Neungan-ro, Dan...
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Boryeong Co., Ltd.
2020-02-11
1689-6-ND
Boryeong Co., Ltd. @Borye...
South Korea
254 Chungseo-ro, Eungbong...
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Boryeong Co., Ltd.
2010-08-31
1689-1-ND
Boryeong Co., Ltd.
South Korea
107, 109, Neungan-ro, Dan...
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Ace Biopharm Co., Ltd.
2022-08-03
Wed289-15-ND
KIMIA BIOSCIENCES LIMITED
India
Village Bhondsi, Tehsil S...
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Kookjeon Pharmaceutical Co., Ltd.
2022-03-15
2520-35-ND
Kukjeon Pharmaceutical Co...
South Korea
8 Balangongdan-ro, Hyangn...
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MFC

Contact Supplier
    URL Supplier Web Content
    MFC Co., Ltd.
    2023-01-26
    346-6-ND
    MFC Co., Ltd. @KPX Life S...
    South Korea
    35 Cheongwonsandan 7-gil,...
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    Donggu Bio Pharmaceutical Co., Ltd.
    2022-04-26
    Number 812-17-ND(1)
    Zydus Lifesciences Limite...
    India
    Unit-Ⅱ, Plot No:5/1-B, ...
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    Mpeak Korea Co., Ltd.
    2022-03-28
    Wed812-17-ND
    Zydus Lifesciences Limite...
    India
    Unit-Ⅱ, Plot No:5/1-B, ...
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    Looking for 247257-48-3 / Fimasartan API manufacturers, exporters & distributors?

    Fimasartan manufacturers, exporters & distributors 1

    70

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

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

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

    API | Excipient name

    Fimasartan

    Synonyms

    247257-48-3, Kanarb, Fimasartan [inn], 2-(1-((2'-(2h-tetrazol-5-yl)-[1,1'-biphenyl]-4-yl)methyl)-2-butyl-4-methyl-6-oxo-1,6-dihydropyrimidin-5-yl)-n,n-dimethylethanethioamide, Chembl1951143, Fimasartan (inn)

    Cas Number

    247257-48-3

    Unique Ingredient Identifier (UNII)

    P58222188P

    About Fimasartan

    Fimasartan is an angiotensin II receptor antagonist (ARB) drug employed in the treatment of both hypertension and heart failure. It has been found to be safe when administered with hydrochlorothiazide (a diuretic) in clinical trials. Fimasartan was initially approved September 9th, 2010 in South Korea and is marketed under the brand name Kanarb by Boryung Pharmaceuticals.

    Fimasartan Manufacturers

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

    Fimasartan Suppliers

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

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

    Fimasartan KDMF

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

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

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

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

    Fimasartan Manufacturers | Traders | Suppliers

    Fimasartan Manufacturers, Traders, Suppliers 1
    47

    We have 6 companies offering Fimasartan

    Get in contact with the supplier of your choice:

    1. Ami Lifesciences Private Limited
    2. Boryung Pharmaceutical Co., Ltd
    3. Kimia Biosciences
    4. Kukjeon Pharmaceutical
    5. MFC
    6. Zydus Lifesciences
    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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