AMI Lifesciences is Driven by Chemistry. Powered by People.
01 1Ami Lifesciences Private Limited
02 2Archimica
01 1DIACEREIN
02 1DIACEREIN (PROCESS I)
03 1DIACEREIN (PROCESS II)
01 1India
02 2Italy
01 3Active
01 3Blank
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38766
Submission : 2023-09-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23961
Submission : 2010-07-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23960
Submission : 2010-07-13
Status : Active
Type : II
A Diacerein manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diacerein, including repackagers and relabelers. The FDA regulates Diacerein manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diacerein 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 Diacerein manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Diacerein supplier is an individual or a company that provides Diacerein active pharmaceutical ingredient (API) or Diacerein finished formulations upon request. The Diacerein suppliers may include Diacerein API manufacturers, exporters, distributors and traders.
click here to find a list of Diacerein suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Diacerein DMF (Drug Master File) is a document detailing the whole manufacturing process of Diacerein active pharmaceutical ingredient (API) in detail. Different forms of Diacerein DMFs exist exist since differing nations have different regulations, such as Diacerein USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Diacerein DMF submitted to regulatory agencies in the US is known as a USDMF. Diacerein USDMF includes data on Diacerein's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Diacerein USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Diacerein suppliers with USDMF on PharmaCompass.
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