Veranova: A CDMO that manages complexity with confidence.
01 1Veranova
02 1GSK
03 1Lek Pharmaceuticals
04 1Lonza Group
01 4AURANOFIN
01 1Slovenia
02 1Switzerland
03 1U.S.A
04 1United Kingdom
01 1Active
02 3Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15803
Submission : 2002-01-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9748
Submission : 1992-06-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8292
Submission : 1989-11-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4212
Submission : 1981-07-17
Status : Inactive
Type : II
A Auranofin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Auranofin, including repackagers and relabelers. The FDA regulates Auranofin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Auranofin 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 Auranofin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Auranofin supplier is an individual or a company that provides Auranofin active pharmaceutical ingredient (API) or Auranofin finished formulations upon request. The Auranofin suppliers may include Auranofin API manufacturers, exporters, distributors and traders.
click here to find a list of Auranofin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Auranofin DMF (Drug Master File) is a document detailing the whole manufacturing process of Auranofin active pharmaceutical ingredient (API) in detail. Different forms of Auranofin DMFs exist exist since differing nations have different regulations, such as Auranofin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Auranofin DMF submitted to regulatory agencies in the US is known as a USDMF. Auranofin USDMF includes data on Auranofin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Auranofin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Auranofin suppliers with USDMF on PharmaCompass.
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