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

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    Tibolone

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    01 Merck & Co (1)

    02 Qinhuangdao Zizhu Pharmaceutical Co., Ltd. (1)

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    01 TIBOLONE (2)

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    02 U.S.A (1)

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    TIBOLONE

    PDF Supplier PDF
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    13895
    Inactive
    1998-12-14
    N/A
    II
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    QINHUANGDAO ZIZHU PHARMACEUTICAL CO...

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    TIBOLONE

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    29217
    Active
    2015-03-26
    N/A
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    Looking for 5630-53-5 / Tibolone API manufacturers, exporters & distributors?

    Tibolone manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Tibolone

    Synonyms

    5630-53-5, Liviella, Livial, Org od 14, Tibolona, Tibolonum

    Cas Number

    5630-53-5

    Unique Ingredient Identifier (UNII)

    FF9X0205V2

    About Tibolone

    Tibolone is a synthetic anabolic steroid with estrogenic, androgenic and progestagenic activities. The 3alpha- and 3beta-hydroxy metabolites of tibilone activate estrogenic receptors (ERs) in bone and vaginal tissue leading to a decrease in bone turnover, and decreased vaginal dryness, respectively; derived from the 3beta-hydroxy metabolite, its delta4-isomer activates androgenic receptors (ARs) in the brain and liver and progestogenic receptors (PRs) in endometrial tissue, affecting sexual function, lipid metabolism, and endometrial function, respectively. In breast and endometrial tissue, tibolone metabolites inhibit sulfatase, preventing the conversion of circulating estrone sulfate and estradiol sulfate to estrone and estradiol, respectively; estrogen-mediated effects in the breast and uterus are thus reduced.

    Tibolone Manufacturers

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

    Tibolone Suppliers

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

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

    Tibolone USDMF

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

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

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

    Tibolone Manufacturers | Traders | Suppliers

    Tibolone Manufacturers, Traders, Suppliers 1
    80

    We have 2 companies offering Tibolone

    Get in contact with the supplier of your choice:

    1. Merck & Co
    2. Qinhuangdao Zizhu Pharmaceutical Co., Ltd.
    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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