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 MODRASTANE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MODRASTANE, including repackagers and relabelers. The FDA regulates MODRASTANE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MODRASTANE 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 MODRASTANE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A MODRASTANE supplier is an individual or a company that provides MODRASTANE active pharmaceutical ingredient (API) or MODRASTANE finished formulations upon request. The MODRASTANE suppliers may include MODRASTANE API manufacturers, exporters, distributors and traders.
click here to find a list of MODRASTANE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A MODRASTANE DMF (Drug Master File) is a document detailing the whole manufacturing process of MODRASTANE active pharmaceutical ingredient (API) in detail. Different forms of MODRASTANE DMFs exist exist since differing nations have different regulations, such as MODRASTANE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MODRASTANE DMF submitted to regulatory agencies in the US is known as a USDMF. MODRASTANE USDMF includes data on MODRASTANE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MODRASTANE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of MODRASTANE suppliers with USDMF on PharmaCompass.
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