01 1ORGAMOL PHARMA SOLUTIONS SA
02 1Sterling Spa
01 2TRILOSTANE
01 1Italy
02 1Switzerland
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6092
Submission : 1985-11-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19686
Submission : 2006-08-14
Status : Active
Type : II
A Trilostane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trilostane, including repackagers and relabelers. The FDA regulates Trilostane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trilostane 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 Trilostane manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trilostane supplier is an individual or a company that provides Trilostane active pharmaceutical ingredient (API) or Trilostane finished formulations upon request. The Trilostane suppliers may include Trilostane API manufacturers, exporters, distributors and traders.
click here to find a list of Trilostane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trilostane DMF (Drug Master File) is a document detailing the whole manufacturing process of Trilostane active pharmaceutical ingredient (API) in detail. Different forms of Trilostane DMFs exist exist since differing nations have different regulations, such as Trilostane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trilostane DMF submitted to regulatory agencies in the US is known as a USDMF. Trilostane USDMF includes data on Trilostane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trilostane USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trilostane suppliers with USDMF on PharmaCompass.
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