Donepezil Donepezil

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

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20130409-158-I-79-13(1)
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2017-05-04
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2018-06-05
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2017-12-08
20150618-158-I-428-25(5)
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2019-04-04
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2015-06-18
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2019-01-07
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2019-11-22
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2013-03-22
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2014-01-08
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2013-05-27
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2013-11-08
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2018-12-28
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Toru Co., Ltd.
2019-10-17
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Pharmapia Co., Ltd.
2019-04-04
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Withers Pharmaceutical Co., Ltd.
2017-01-11
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2013-12-27
20110715-158-I-2-05(8)
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2019-12-09
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Handok Co., Ltd.
2020-01-08
20120703-158-I-57-06(1)
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Kolon Pharmaceutical Co., Ltd.
2018-05-10
20120919-158-I-131-10(3)
Hetero Drugs Limited
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HK Innoen Co., Ltd.
2014-08-29
20120919-158-I-131-10(1)
Hetero Drugs Limited
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Youngjin Pharmaceutical Co., Ltd.
2017-09-12
20120919-158-I-131-10(2)
Hetero Drugs Limited
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Sungwoo Chemical Co., Ltd.
2018-06-25
20120919-158-I-131-10(4)
Hetero Drugs Limited
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J2H Biotech Co., Ltd.
2022-11-08
20221108-158-I-651-36
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Masung LS Co., Ltd.
2014-07-25
20140725-15-I-415-22
Jubilant Pharmova Limited
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Hwail Pharmaceutical Co., Ltd.
2015-03-24
20140725-15-I-415-22(1)
Jubilant Pharmova Limited
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Pharmapia Co., Ltd.
2018-06-27
20140725-15-I-415-22(2)
Jubilant Generics Limited
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Kolon Life Science Co., Ltd.
2023-09-18
20230918-158-I-663-38
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Korea Biochem Pharmaceutical Co., Ltd.
2021-11-10
20211110-158-I-628-30
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2021-02-25
20210225-158-I-618-28
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    2022-10-19
    20221019-158-I-650-35
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    2022-11-24
    20221124-158-I-652-37
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    2019-03-06
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    2013-05-15
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    2013-04-26
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    Seoul Pharmaceutical Co., Ltd.
    2014-03-10
    20120703-158-I-43-07(2)
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    2021-11-08
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    • TABLET;ORAL - 10MG
    • TABLET;ORAL - 5MG
    • TABLET, ORALLY DISINTEGRATING;ORAL - 10MG
    • TABLET, ORALLY DISINTEGRATING;ORAL - 5MG
    • TABLET;ORAL - 23MG

    Looking for 120011-70-3 / Donepezil API manufacturers, exporters & distributors?

    Donepezil manufacturers, exporters & distributors 1

    84

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

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

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

    API | Excipient name

    Donepezil

    Synonyms

    120011-70-3, Donepezil hcl, Aricept, Bnag, 110119-84-1, 2-((1-benzylpiperidin-4-yl)methyl)-5,6-dimethoxy-2,3-dihydro-1h-inden-1-one hydrochloride

    Cas Number

    120011-70-3

    Unique Ingredient Identifier (UNII)

    3O2T2PJ89D

    About Donepezil

    An indan and piperidine derivative that acts as a selective and reversible inhibitor of ACETYLCHOLINESTERASE. Donepezil is highly selective for the central nervous system and is used in the management of mild to moderate DEMENTIA in ALZHEIMER DISEASE.

    Donepezil Manufacturers

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

    Donepezil Suppliers

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

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

    Donepezil KDMF

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

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

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

    click here to find a list of Donepezil 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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