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

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    Eliglustat

    APIs // Active Pharmaceutical Ingredients

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    CordenPharma

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    Eliglustat Tartrate

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    Sanofi-Aventis Korea Co., Ltd.
    2019-09-26
    Number 63-7-ND
    Corden Pharma Switzerland...
    Switzerland
    Eichenweg 1, 4410 Liestal...
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    Looking for 928659-70-5 / Eliglustat API manufacturers, exporters & distributors?

    Eliglustat manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Eliglustat

    Synonyms

    Eliglustat hemitartrate, Cerdelga, 928659-70-5, Agalsidase beta, Eliglustat (hemitartrate), Genz-112638

    Cas Number

    928659-70-5

    Unique Ingredient Identifier (UNII)

    N0493335P3

    About Eliglustat

    Agalsidase beta is a recombinant human -galactosidase A similar to [agalsidase alfa]. While patients generally do not experience a clinically significant difference in outcomes between the two drugs, some patients may experience greater benefit with agalsidase beta. Use of agalsidase beta has decreased in Europe, in favor of agalsidase alfa, after a contamination event in 2009. Agalsidase beta was granted FDA approval on 24 April 2003.

    Eliglustat Manufacturers

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

    Eliglustat Suppliers

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

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

    Eliglustat KDMF

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

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

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

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

    Eliglustat Manufacturers | Traders | Suppliers

    Eliglustat Manufacturers, Traders, Suppliers 1
    76

    We have 1 companies offering Eliglustat

    Get in contact with the supplier of your choice:

    1. CordenPharma
    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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