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 (JDMF) for Mitotane Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

    Client Email Product
    Menu

    Mitotane

    APIs // Active Pharmaceutical Ingredients

    DOSSIERs // Finished Dosage Forms

    RELATED EXCIPIENT COMPANIES

    EXCIPIENTS BY APPLICATIONS

    GLOBAL SALES INFORMATION

    MARKET PLACE

    ANALYTICAL SOLUTION(s)

    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 Ashland Inc. (1)

    filter

    01 Mitotane (1)

    filter

    01 U.S.A (1)

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

    Ashland Inc.

    Contact Supplier
      Virtual Booth Upload your Marketing & Sales content on your company Virtual Booth, click HERE
      Post an Enquiry Post an Enquiry
      Flag U.S.A
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      Mitotane

      PDF Supplier PDF
      URL Supplier Web Content
      224MF10186
      8145 Blazer Drive, Wilmington, DE, ...
      2023-07-05
      2012-09-03
      ASK
      US
      PHARMACOMPASS
      Upload
      your Marketing & Sales content

      Looking for 53-19-0 / Mitotane API manufacturers, exporters & distributors?

      Mitotane manufacturers, exporters & distributors 1

      32

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

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

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

      API | Excipient name

      Mitotane

      Synonyms

      53-19-0, Mitotan, Lysodren, O,p'-ddd, Chlodithane, Chloditan

      Cas Number

      53-19-0

      Unique Ingredient Identifier (UNII)

      78E4J5IB5J

      About Mitotane

      A derivative of the insecticide DICHLORODIPHENYLDICHLOROETHANE that specifically inhibits cells of the adrenal cortex and their production of hormones. It is used to treat adrenocortical tumors and causes CNS damage, but no bone marrow depression.

      Mitotane Manufacturers

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

      Mitotane Suppliers

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

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

      Mitotane JDMF

      The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

      The Mitotane Drug Master File in Japan (Mitotane JDMF) empowers Mitotane API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

      PMDA reviews the Mitotane JDMF during the approval evaluation for pharmaceutical products. At the time of Mitotane JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

      click here to find a list of Mitotane suppliers with JDMF on PharmaCompass.

      Mitotane Manufacturers | Traders | Suppliers

      Mitotane Manufacturers, Traders, Suppliers 1
      83

      We have 1 companies offering Mitotane

      Get in contact with the supplier of your choice:

      1. INTERNATIONAL SPECIALTY PRODUCTS
      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