01 1Olon S.p.A
02 1Siegfried AG
01 2ALITRETINOIN
01 1Italy
02 1Switzerland
01 2Active
01 1Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-10
Pay. Date : 2015-09-22
DMF Number : 27553
Submission : 2013-09-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28746
Submission : 2014-10-08
Status : Active
Type : II
A Alitretinoin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alitretinoin, including repackagers and relabelers. The FDA regulates Alitretinoin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alitretinoin 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 Alitretinoin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alitretinoin supplier is an individual or a company that provides Alitretinoin active pharmaceutical ingredient (API) or Alitretinoin finished formulations upon request. The Alitretinoin suppliers may include Alitretinoin API manufacturers, exporters, distributors and traders.
click here to find a list of Alitretinoin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alitretinoin DMF (Drug Master File) is a document detailing the whole manufacturing process of Alitretinoin active pharmaceutical ingredient (API) in detail. Different forms of Alitretinoin DMFs exist exist since differing nations have different regulations, such as Alitretinoin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alitretinoin DMF submitted to regulatory agencies in the US is known as a USDMF. Alitretinoin USDMF includes data on Alitretinoin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alitretinoin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alitretinoin suppliers with USDMF on PharmaCompass.
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