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01 1Astellas Pharma

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PharmaCompass

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.

Zotepina Manufacturers

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

Zotepina Suppliers

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

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

Zotepina USDMF

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

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

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

Zotepina Manufacturers | Traders | Suppliers

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

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.