01 1ADC Review
01 1SG-3249 DRUG LINKER
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32128
Submission : 2018-01-25
Status : Inactive
Type : II
13
PharmaCompass offers a list of Tesirine 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 Tesirine manufacturer or Tesirine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tesirine manufacturer or Tesirine supplier.
A Tesirine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tesirine, including repackagers and relabelers. The FDA regulates Tesirine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tesirine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Tesirine supplier is an individual or a company that provides Tesirine active pharmaceutical ingredient (API) or Tesirine finished formulations upon request. The Tesirine suppliers may include Tesirine API manufacturers, exporters, distributors and traders.
click here to find a list of Tesirine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Tesirine DMF (Drug Master File) is a document detailing the whole manufacturing process of Tesirine active pharmaceutical ingredient (API) in detail. Different forms of Tesirine DMFs exist exist since differing nations have different regulations, such as Tesirine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tesirine DMF submitted to regulatory agencies in the US is known as a USDMF. Tesirine USDMF includes data on Tesirine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tesirine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tesirine suppliers with USDMF on PharmaCompass.
