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

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    Nuvigil

    APIs // Active Pharmaceutical Ingredients

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    Pliva Hrvatska

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    Armodafinil

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    Handok Teva Co., Ltd.
    2020-09-29
    20200929-209-J-737
    PLIVA Croatia Ltd
    Croatia
    Prudnička cesta 54 10291...
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    Looking for 112111-43-0 / Armodafinil API manufacturers, exporters & distributors?

    Armodafinil manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Armodafinil

    Synonyms

    112111-43-0, Nuvigil, (r)-modafinil, (-)-modafinil, (r)-(-)-modafinil, Cep-10953

    Cas Number

    112111-43-0

    Unique Ingredient Identifier (UNII)

    V63XWA605I

    About Armodafinil

    A benzhydryl acetamide compound, central nervous system stimulant, and CYP3A4 inducing agent that is used in the treatment of NARCOLEPSY and SLEEP WAKE DISORDERS.

    Nuvigil Manufacturers

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

    Nuvigil Suppliers

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

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

    Nuvigil KDMF

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

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

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

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

    Nuvigil Manufacturers | Traders | Suppliers

    Nuvigil Manufacturers, Traders, Suppliers 1
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    We have 1 companies offering Nuvigil

    Get in contact with the supplier of your choice:

    1. Pliva Hrvatska
    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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