01 1ISP Chemicals, LLC
02 1Zhejiang Supor Pharmaceuticals Co., LTD
01 1MITOTANE
02 1SYNTHETIC PROCEDURE FOR MITOTANE
01 1China
02 1U.S.A
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9007
Submission : 1991-03-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23947
Submission : 2010-06-14
Status : Active
Type : II
A Mitotane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mitotane, including repackagers and relabelers. The FDA regulates Mitotane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mitotane 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 Mitotane manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mitotane supplier is an individual or a company that provides Mitotane active pharmaceutical ingredient (API) or Mitotane finished formulations upon request. The Mitotane suppliers may include Mitotane API manufacturers, exporters, distributors and traders.
click here to find a list of Mitotane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mitotane DMF (Drug Master File) is a document detailing the whole manufacturing process of Mitotane active pharmaceutical ingredient (API) in detail. Different forms of Mitotane DMFs exist exist since differing nations have different regulations, such as Mitotane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mitotane DMF submitted to regulatory agencies in the US is known as a USDMF. Mitotane USDMF includes data on Mitotane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mitotane USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mitotane suppliers with USDMF on PharmaCompass.
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