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    Nipolept

    ACTIVE PHARMA INGREDIENTS

    MARKET PLACE

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    PharmaCompass

    Looking for 26615-21-4 / Zotepine API manufacturers, exporters & distributors?

    Zotepine manufacturers, exporters & distributors 1

    32

    PharmaCompass offers a list of Zotepine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.

    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.

    Nipolept Manufacturers

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

    Nipolept Suppliers

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

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

    Nipolept USDMF

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

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

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

    Nipolept Manufacturers | Traders | Suppliers

    Nipolept Manufacturers, Traders, Suppliers 1
    18

    We have 1 companies offering Nipolept

    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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