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    List of Drug Master Files (JDMF) for Ozenoxacin Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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    Ozenoxacin

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    Interquim S. A.

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    ozenoxacin

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    226MF10031
    Joan Buscala, 10 E-08173 Sant Cugat...
    2022-08-03
    2014-02-05
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    Looking for 245765-41-7 / Ozenoxacin API manufacturers, exporters & distributors?

    Ozenoxacin manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Ozenoxacin

    Synonyms

    245765-41-7, Xepi, T-3912, T 3912, 1-cyclopropyl-8-methyl-7-[5-methyl-6-(methylamino)pyridin-3-yl]-4-oxoquinoline-3-carboxylic acid, Gf-001001-00

    Cas Number

    245765-41-7

    Unique Ingredient Identifier (UNII)

    V0LH498RFO

    About Ozenoxacin

    To date, ozenoxacin has been used in trials studying the treatment of impetigo. As of December 11, 2017 the FDA approved Ferrer Internacional S.A.'s Xepi (ozenoxacin 1%) as a topically applied cream indicated for the treatment of impetigo caused by *Staphylococccus aureus* or *Streptococcus pyogenes* in adult and pediatric patients 2 months of age and older. Despite being a common and highly contagious bacerial skin infection that affects millions of children and adults in the United States each year, ozenoxacin cream is a novel, non-fluorinated quinolone that has demonstrated safe and effective therapy in both the adult and pediatric population.

    Ozenoxacin Manufacturers

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

    Ozenoxacin Suppliers

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

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

    Ozenoxacin 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 Ozenoxacin Drug Master File in Japan (Ozenoxacin JDMF) empowers Ozenoxacin 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 Ozenoxacin JDMF during the approval evaluation for pharmaceutical products. At the time of Ozenoxacin 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 Ozenoxacin suppliers with JDMF on PharmaCompass.

    Ozenoxacin Manufacturers | Traders | Suppliers

    Ozenoxacin Manufacturers, Traders, Suppliers 1
    15

    We have 1 companies offering Ozenoxacin

    Get in contact with the supplier of your choice:

    1. Interquim SA
    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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