01 1Astellas Pharma
01 1ZOTEPINE DRUG SUBSTANCE
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10116
Submission : 1993-03-03
Status : Inactive
Type : II
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.
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, and COA related information on PhamaCompass.
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, and COA related information on PharmaCompass.
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.
We have 1 companies offering Zotepine
Get in contact with the supplier of your choice:
