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

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    Epinastine Hydrochloride

    APIs // Active Pharmaceutical Ingredients

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    01 Excella GmbH & Co. K.G. (2)

    02 Boehringer Ingelheim GmbH & Co.KG (1)

    03 Chongqing Succeway Pharmaceutical Co.,Ltd. @Jeil Pharmaceutical Co., Ltd. @[Starting material (epinastine bromine salt) manufacturer ①] Pharmacostek Co., Ltd. @[Starting material (epinastine bromine salt) manufacturer ②] Dongin Chemical Co., Ltd. @[Starti (1)

    04 Hubei Haosun Pharmaceutical Co., Ltd.@Anhui Heryi Pharmaceutical Co., Ltd. (1)

    05 ICROM SpA (5)

    06 Pharmacotech Co., Ltd. (1)

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

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    01 Boehringer Ingelheim Korea Co., Ltd. (1)

    02 Colmar Pharma Co., Ltd. (1)

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

    04 Inseong Trading Co., Ltd. (1)

    05 Jeil Pharmaceutical Co., Ltd. (1)

    06 Jeil Pharmtech Co., Ltd. (1)

    07 Kookjeon Pharmaceutical Co., Ltd. (1)

    08 Pharmacotech Co., Ltd. (1)

    09 Samchundang Pharmaceutical Co., Ltd. (2)

    10 Samo Pharmaceutical Co., Ltd. (1)

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

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    01 Epinastine hydrochloride (12)

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    01 Germany (1)

    02 Italy (5)

    03 Japan (1)

    04 Luxembourg (2)

    05 South Korea (3)

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    Fareva

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    • FDA
    • EDQM
    Virtual BoothFareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
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    Epinastine hydrochloride

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    Samchundang Pharmaceutical Co., Ltd.
    2014-04-24
    20140327-194-I-378-04(1)
    Excella GmbH & Co. K.G.
    Germany
    Nurnberger Str. 12 90537 ...
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    CPhI North America

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    Fareva

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    • FDA
    • EDQM
    Virtual BoothFareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
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    Epinastine hydrochloride

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    Samo Pharmaceutical Co., Ltd.
    2014-03-27
    20140327-194-I-378-04
    Excella GmbH & Co. K.G.
    Germany
    Nurnberger Str. 12 90537 ...
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    CPhI North America

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    Icrom

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    Epinastine hydrochloride

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    Colmar Pharma Co., Ltd.
    2016-05-17
    20130731-194-I-355-03(4)
    ICROM SpA
    Italy
    Concorezzo (MB) - Via Del...
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    Icrom

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    Epinastine hydrochloride

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    Jeil Pharmtech Co., Ltd.
    2013-07-31
    20130731-194-I-355-03
    ICROM SpA
    Italy
    Concorezzo (MB) - Via Del...
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    Icrom

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    Epinastine hydrochloride

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    Samchundang Pharmaceutical Co., Ltd.
    2016-04-26
    20130731-194-I-355-03(5)
    ICROM SpA
    Italy
    Concorezzo (MB) - Via Del...
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    Icrom

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    Epinastine hydrochloride

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    Donggu Bio Pharmaceutical Co., Ltd.
    2014-02-18
    20130731-194-I-355-03(1)
    ICROM SpA
    Italy
    Concorezzo (MB) - Via Del...
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    Icrom

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    Epinastine hydrochloride

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    Inseong Trading Co., Ltd.
    2019-05-27
    20130731-194-I-355-03(6)
    ICROM SpA
    Italy
    Concorezzo(MB)-Via Delle ...
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    Kukjeon Pharmaceutical

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      Epinastine hydrochloride

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      Kookjeon Pharmaceutical Co., Ltd.
      2015-04-15
      20150415-194-I-466-05
      Hubei Haosun Pharmaceutic...
      South Korea
      8@No.20 Juxian Road, Gedi...
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      Pharmacostech

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        Epinastine hydrochloride

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        Pharmacotech Co., Ltd.
        2018-05-16
        20180516-194-I-554-06
        Pharmacotech Co., Ltd.
        South Korea
        Block 35-2, Balan Regiona...
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        Yuil Pharm

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          Epinastine hydrochloride

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          Yuil Farm Tech Co., Ltd.
          2021-09-16
          20210916-194-I-625-07
          Yuil Farm Tech Co., Ltd.
          South Korea
          3 Mulmi-gil, Iwol-myeon, ...
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          Looking for 80012-44-8 / Epinastine Hydrochloride API manufacturers, exporters & distributors?

          Epinastine Hydrochloride manufacturers, exporters & distributors 1

          34

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

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

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

          API | Excipient name

          Epinastine Hydrochloride

          Synonyms

          Epinastine hcl, 108929-04-0, Alesion, Elestat, Wal-801cl, 80012-44-8

          Cas Number

          80012-44-8

          Unique Ingredient Identifier (UNII)

          GFM415S5XL

          About Epinastine Hydrochloride

          Epinastine Hydrochloride is an histamine H1 receptor antagonist without sedative activity. Epinastine hydrochloride blocks the histamine H1 receptor and inhibits the release of histamine from mast cells. This prevents the typical allergic symptoms that are caused by histamine activity on capillaries, skin, mucous membranes, and on gastrointestinal and bronchial smooth muscles. Typical histamine activities include vasodilation, bronchoconstriction, increased vascular permeability, pain, itching, and spasmodic contractions of gastrointestinal smooth muscles. Epinastine also has affinity for the histamine H2, 5-HT2, and the alpha-1, alpha-2 adrenergic receptors.

          Epinastine (hydrochloride) Manufacturers

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

          Epinastine (hydrochloride) Suppliers

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

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

          Epinastine (hydrochloride) KDMF

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

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

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

          click here to find a list of Epinastine (hydrochloride) suppliers with KDMF on PharmaCompass.

          Epinastine (hydrochloride) Manufacturers | Traders | Suppliers

          Epinastine (hydrochloride) Manufacturers, Traders, Suppliers 1
          93

          We have 7 companies offering Epinastine (hydrochloride)

          Get in contact with the supplier of your choice:

          1. Fareva
          2. Boehringer Ingelheim GmbH
          3. Icrom
          4. Jeil Pharmaceutical Co., Ltd
          5. Kukjeon Pharmaceutical
          6. Pharmacostech
          7. Yuil Pharm
          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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