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

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    Carglumic Acid

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    01 Nuray Chemicals Private Limited (1)

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    NOVITIUM PHARMA LLC

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    Virtual BoothNuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
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    CARGLUMIC ACID

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    Other DMF ASMF
    33166
    Active
    2018-12-07
    Complete
    2019-01-11
    2018-12-14
    II
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    EMWA 2024

    Not Confirmed

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    PROCOS SPA

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    CARGLUMIC ACID

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    38477
    Active
    2023-07-12
    Complete
    2024-01-03
    2023-09-27
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    RECORDATI INDUSTRIA CHIMICA E FARMA...

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    CARGLUMIC ACID

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    26955
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    2013-03-06
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    Looking for 1188-38-1 / Carglumic Acid API manufacturers, exporters & distributors?

    Carglumic Acid manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Carglumic Acid

    Synonyms

    1188-38-1, N-carbamyl-l-glutamic acid, (s)-2-ureidopentanedioic acid, Carbaglu, N-carbamylglutamate, N-carbamoyl-l-glutamic acid

    Cas Number

    1188-38-1

    Unique Ingredient Identifier (UNII)

    5L0HB4V1EW

    About Carglumic Acid

    Carglumic Acid is an orally active, synthetic structural analogue of N-acetylglutamate (NAG) and carbamoyl phosphate synthetase 1 (CPS 1) activator, with ammonia lowering activity. NAG, which is formed by the hepatic enzyme N-acetylglutamate synthase (NAGS), is an essential allosteric activator of the enzyme carbamoyl phosphate synthetase 1 (CPS 1). CPS 1 plays an essential role in the urea cycle and converts ammonia into urea. Upon oral administration, carglumic acid can replace NAG in NAGS deficient patients and activates CPS 1, which prevents hyperammonaemia.

    Carglumic Acid Manufacturers

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

    Carglumic Acid Suppliers

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

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

    Carglumic Acid USDMF

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

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

    click here to find a list of Carglumic Acid suppliers with USDMF on PharmaCompass.

    Carglumic Acid Manufacturers | Traders | Suppliers

    Carglumic Acid Manufacturers, Traders, Suppliers 1
    77

    We have 3 companies offering Carglumic Acid

    Get in contact with the supplier of your choice:

    1. Nuray Chemicals Private Limited
    2. Procos
    3. Recordati
    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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