loader
Please Wait
Applying Filters...

Bora CDMO Bora CDMO

X
menu

    Market Place

    Market Place

    Post Enquiry

    Post Enquiry
    menu

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

    Client Email Product
    Menu

    Vibegron

    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    PRICE INFORMATION

    INTERMEDIATES

    DOSSIERs // Finished Dosage Forms

    GLOBAL SALES INFORMATION

    MARKET PLACE

    PATENTS

    DIGITAL CONTENT

    PharmaCompass

    Phyton is a World Leader in Plant Cell Fermentation Technology and Commercial Manufacturing.

    Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

    Left Arrow
    Right Arrow
    Filters Filter
    Cross PopUp
    FILTER :

    filter

    01 Sumitomo Chemicals Co., Ltd. Gifu Plant, Oita Works (1)

    filter

    01 Jeil Pharmaceutical Co., Ltd. (1)

    filter

    01 Vibegron (1)

    filter

    01 Japan (1)

    ListList of Suppliers
    refreshReset Filter
    refresh Reset Filter
    Price Info Price Info
    product-page Product Main Page

    Sumitomo Chemical

    Contact Supplier
    • FDA
    • EDQM
    Virtual Booth Upload your Marketing & Sales content on your company Virtual Booth, click HERE
    Post an Enquiry Post an Enquiry
    Flag Japan
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Vibegron

    PDF Supplier PDF
    URL Supplier Web Content
    Jeil Pharmaceutical Co., Ltd.
    2022-10-31
    Wed216-24-ND
    Sumitomo Chemicals Co., L...
    Japan
    3750, Azajuhachicho, Maki...
    ASK
    US
    PHARMACOMPASS
    Upload
    your Marketing & Sales content

    Looking for 1190389-15-1 / Vibegron API manufacturers, exporters & distributors?

    Vibegron manufacturers, exporters & distributors 1

    22

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

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

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

    API | Excipient name

    Vibegron

    Synonyms

    1190389-15-1, Krp-114v, Gemtesa, Mk-4618, (s)-n-(4-(((2s,5r)-5-((r)-hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo[1,2-a]pyrimidine-6-carboxamide, M5tse03w5u

    Cas Number

    1190389-15-1

    Unique Ingredient Identifier (UNII)

    M5TSE03W5U

    About Vibegron

    Vibegron is a potent, selective beta-3 adrenergic receptor (3) agonist that relaxes the detrusor smooth muscle of the bladder, thereby increasing bladder capacity. Vibegron was first approved in Japan in September 2018 for the treatment of overactive bladder, a condition associated with distressing symptoms of urge urinary incontinence, urgency, and urinary frequency, and reduced quality of life of patients. On December 23, 2020, vibegron was approved for the same indication in adults. It is available as oral tablets under the market name GEMTESA. Vibegron is the second beta-3 adrenergic agonist approved for the treatment of overactive bladder following [mirabegron], which was approved in 2012. Unlike mirabegron, vibegron is less likely to be associated with drug-drug interactions involving the CYP3A4, 2D6, or 2C9 enzymes.

    Vibegron Manufacturers

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

    Vibegron Suppliers

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

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

    Vibegron KDMF

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

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

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

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

    Vibegron Manufacturers | Traders | Suppliers

    Vibegron Manufacturers, Traders, Suppliers 1
    12

    We have 1 companies offering Vibegron

    Get in contact with the supplier of your choice:

    1. Sumitomo Chemical
    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.
    Post Enquiry
    POST ENQUIRY