01 2MSN Laboratories
02 1Shandong Anhong Pharmaceutical
01 3ABEMACICLIB
01 1China
02 2India
01 3Active
01 1Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40612
Submission : 2024-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34714
Submission : 2020-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-09-23
Pay. Date : 2024-08-27
DMF Number : 40315
Submission : 2024-08-30
Status : Active
Type : II
A Abemaciclib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Abemaciclib, including repackagers and relabelers. The FDA regulates Abemaciclib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Abemaciclib 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 Abemaciclib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Abemaciclib supplier is an individual or a company that provides Abemaciclib active pharmaceutical ingredient (API) or Abemaciclib finished formulations upon request. The Abemaciclib suppliers may include Abemaciclib API manufacturers, exporters, distributors and traders.
click here to find a list of Abemaciclib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Abemaciclib DMF (Drug Master File) is a document detailing the whole manufacturing process of Abemaciclib active pharmaceutical ingredient (API) in detail. Different forms of Abemaciclib DMFs exist exist since differing nations have different regulations, such as Abemaciclib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Abemaciclib DMF submitted to regulatory agencies in the US is known as a USDMF. Abemaciclib USDMF includes data on Abemaciclib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Abemaciclib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Abemaciclib suppliers with USDMF on PharmaCompass.
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