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    List of Drug Master Files (DMF) of Potassium Oxybate Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Potassium Oxybate

    APIs // Active Pharmaceutical Ingredients

    DOSSIERs // Finished Dosage Forms

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    01 Cambrex Corporation (1)

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    01 POTASSIUM OXYBATE (1)

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    01 U.S.A (1)

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    01 Active (1)

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    01 Complete (1)

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    CAMBREX CHARLES CITY INC

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    POTASSIUM OXYBATE

    PDF Supplier PDF
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    35872
    Active
    2022-04-26
    Complete
    2022-07-25
    2022-05-17
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    Looking for 57769-01-4 / Potassium Oxybate API manufacturers, exporters & distributors?

    Potassium Oxybate manufacturers, exporters & distributors 1

    34

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

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

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

    API | Excipient name

    Potassium Oxybate

    Synonyms

    4-hydroxybutanoic acid potassium salt, S8nkf3h3kt, 4-hydroxybutyric acid potassium salt, Butanoic acid, 4-hydroxy-, potassium salt (1:1), 57769-01-4, Oxybate potassium

    Cas Number

    57769-01-4

    Unique Ingredient Identifier (UNII)

    S8NKF3H3KT

    Potassium Oxybate Manufacturers

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

    Potassium Oxybate Suppliers

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

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

    Potassium Oxybate USDMF

    A Potassium Oxybate DMF (Drug Master File) is a document detailing the whole manufacturing process of Potassium Oxybate active pharmaceutical ingredient (API) in detail. Different forms of Potassium Oxybate DMFs exist exist since differing nations have different regulations, such as Potassium Oxybate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Potassium Oxybate DMF submitted to regulatory agencies in the US is known as a USDMF. Potassium Oxybate USDMF includes data on Potassium Oxybate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Potassium Oxybate USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Potassium Oxybate suppliers with USDMF on PharmaCompass.

    Potassium Oxybate Manufacturers | Traders | Suppliers

    Potassium Oxybate Manufacturers, Traders, Suppliers 1
    57

    We have 1 companies offering Potassium Oxybate

    Get in contact with the supplier of your choice:

    1. Cambrex 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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