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

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    01 Aurobindo Pharma Limited (1)

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    APITORIA PHARMA PRIVATE LTD

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    UBROGEPANT

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    38648
    Active
    2023-08-11
    Complete
    2023-09-26
    2023-08-09
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    HONOUR LAB LTD

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    UBROGEPANT

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    38498
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    2023-06-23
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    2023-08-08
    2023-06-16
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    MSN LIFE SCIENCES PRIVATE LTD

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    UBROGEPANT

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    38576
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    2023-08-02
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    2023-08-31
    2023-08-08
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    Looking for 1374248-77-7 / Ubrogepant API manufacturers, exporters & distributors?

    Ubrogepant manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Ubrogepant

    Synonyms

    1374248-77-7, Ubrelvy, Mk-1602, Ubrogepant anhydrous, Ad0o8x2qjr, (3's)-n-((3s,5s,6r)-6-methyl-2-oxo-5-phenyl-1-(2,2,2-trifluoroethyl)piperidin-3-yl)-2'-oxo-1',2',5,7-tetrahydrospiro(cyclopenta(b)pyridine-6,3'-pyrrolo(2,3-b)pyridine)-3-carboxamide

    Cas Number

    1374248-77-7

    Unique Ingredient Identifier (UNII)

    AD0O8X2QJR

    About Ubrogepant

    Ubrogepant is indicated for the acute treatment of migraine headaches with or without aura in adults. It was approved by the FDA on December 23, 2019, and is the first oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine. Several oral small molecule CGRP receptor antagonists, belonging to a class of medications referred to as "gepants", have been investigated for migraines, but only ubrogepant and [rimegepant] remain in clinical development. Previous agents within this class were efficacious but limited by liver toxicity - this led to the development of ubrogepant, which was designed to be a hepatoxicity-free alternative to its predecessors. Several parenteral monoclonal antibodies acting against the CGRP pathway (e.g. [erenumab], [fremanezumab], [galcanezumab]) have also been approved in recent years. Compared to the current standard of therapy for migraine treatment, namely triptans such as [sumatriptan] and [almotriptan], CGRP antagonists present several advantages. They appear to be better tolerated, do not contribute to medication overuse headaches, and carry no apparent cardiovascular risk, making them suitable for use in patients with cardiovascular disease. The development of oral gepants, including ubrogepant, may therefore constitute a significant advance in migraine headache treatment and may become the new standard of therapy in the treatment of this debilitating condition.

    Ubrogepant Manufacturers

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

    Ubrogepant Suppliers

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

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

    Ubrogepant USDMF

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

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

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

    Ubrogepant Manufacturers | Traders | Suppliers

    Ubrogepant Manufacturers, Traders, Suppliers 1
    82

    We have 3 companies offering Ubrogepant

    Get in contact with the supplier of your choice:

    1. Aurobindo Pharma Limited
    2. HONOUR LAB LTD
    3. MSN Laboratories
    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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