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

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    Zotepine

    APIs // Active Pharmaceutical Ingredients

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    01 Astellas Pharma (1)

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    01 ZOTEPINE DRUG SUBSTANCE (1)

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    01 Japan (1)

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    FUJISAWA PHARMACEUTICAL CO LTD

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    ZOTEPINE DRUG SUBSTANCE

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    10116
    Inactive
    1993-03-03
    N/A
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    Looking for 26615-21-4 / Zotepine API manufacturers, exporters & distributors?

    Zotepine manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Zotepine

    Synonyms

    26615-21-4, Nipolept, Lodopin, Zoleptil, Zotepina, Zotepinum

    Cas Number

    26615-21-4

    Unique Ingredient Identifier (UNII)

    U29O83JAZW

    About Zotepine

    Zotepine, with the formula (2-chloro-11-(2-dimethyl-amino-ethoxy)-dibenzo thiepin, is a neuroleptic drug. It was designed and synthesized by Fujisawa Pharmaceutical Co Ltd. It has been used as an antipsychotic in Japan, India and some places in Europe like UK and Germany since 1980's. Zotepine was never approved by the FDA. In 1993, it was classified as inactive drug substance (Status I, Type II) and in 1995 the FDA studied the manufacturing procedures of Zotepine tablets in Germany, but the status remained inactive. When the analysis of antipsychotics was retaken in 2016 by the FDA, zotepine did not reach the threshold effect to be further studied.. In the EMA, by 2015 it was under pharmacovigilance studies for the potential treatment of acute renal failure.

    Zotepine Manufacturers

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

    Zotepine Suppliers

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

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

    Zotepine USDMF

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

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

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

    Zotepine Manufacturers | Traders | Suppliers

    Zotepine Manufacturers, Traders, Suppliers 1
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    We have 1 companies offering Zotepine

    Get in contact with the supplier of your choice:

    1. Astellas Pharma
    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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