01 1Teva Pharmaceutical Industries
01 1TRILACICLIB
01 1Israel
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-10-24
Pay. Date : 2024-08-07
DMF Number : 40179
Submission : 2024-09-05
Status : Active
Type : II
A Trilaciclib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trilaciclib, including repackagers and relabelers. The FDA regulates Trilaciclib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trilaciclib 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 Trilaciclib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trilaciclib supplier is an individual or a company that provides Trilaciclib active pharmaceutical ingredient (API) or Trilaciclib finished formulations upon request. The Trilaciclib suppliers may include Trilaciclib API manufacturers, exporters, distributors and traders.
click here to find a list of Trilaciclib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trilaciclib DMF (Drug Master File) is a document detailing the whole manufacturing process of Trilaciclib active pharmaceutical ingredient (API) in detail. Different forms of Trilaciclib DMFs exist exist since differing nations have different regulations, such as Trilaciclib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trilaciclib DMF submitted to regulatory agencies in the US is known as a USDMF. Trilaciclib USDMF includes data on Trilaciclib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trilaciclib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trilaciclib suppliers with USDMF on PharmaCompass.
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