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

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    Ertapenem

    APIs // Active Pharmaceutical Ingredients

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    PharmaCompass

    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    01 Cherokee Pharmaceuticals LLC (1)

    02 JW Pharmaceutical Co., Ltd. (1)

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    01 JW Pharmaceutical Co., Ltd. (1)

    02 MSD Korea Co., Ltd. (1)

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    01 Ertapenem Sodium (2)

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    01 South Korea (1)

    02 U.S.A (1)

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    Cherokee Pharmaceuticals LLC

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      Ertapenem Sodium

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      MSD Korea Co., Ltd.
      2020-12-11
      20201211-210-J-798
      Cherokee Pharmaceuticals ...
      U.S.A
      100 Avenue C Riverside, P...
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      JW Pharmaceutical Corporation

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        Ertapenem Sodium

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        JW Pharmaceutical Co., Ltd.
        2019-08-30
        20190830-210-J-419
        JW Pharmaceutical Co., Lt...
        South Korea
        Room 301, 1 Ma, Sihwa Ind...
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        Looking for 153773-82-1 / ertapenem sodium API manufacturers, exporters & distributors?

        ertapenem sodium manufacturers, exporters & distributors 1

        26

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

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

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

        API | Excipient name

        ertapenem sodium

        Synonyms

        Ertapenem monosodium, Ertapenem sodium [usan], Ertapenem monosodium (90per cent), 153773-82-1, Mk 0826, Sodium;(4r,5s,6s)-3-[(3s,5s)-5-[(3-carboxylatophenyl)carbamoyl]pyrrolidin-1-ium-3-yl]sulfanyl-6-[(1r)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate

        Cas Number

        153773-82-1

        About ertapenem sodium

        A carbapenem derivative antibacterial agent that is more stable to renal dehydropeptidase I than IMIPENEM, but does not need to be given with an enzyme inhibitor such as CILASTATIN. It is used in the treatment of Gram-positive and Gram-negative bacterial infections including intra-abdominal infections, acute gynecological infections, complicated urinary tract infections, skin infections, and respiratory tract infections. It is also used to prevent infection in colorectal surgery.

        Ertapenem Manufacturers

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

        Ertapenem Suppliers

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

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

        Ertapenem KDMF

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

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

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

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

        Ertapenem Manufacturers | Traders | Suppliers

        Ertapenem Manufacturers, Traders, Suppliers 1
        42

        We have 2 companies offering Ertapenem

        Get in contact with the supplier of your choice:

        1. Cherokee Pharmaceuticals LLC
        2. JW Pharmaceutical Corporation
        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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