01 1Cilag AG
02 1CytRx Corporation
03 1Par Pharmaceutical
04 1Viatris
01 3MOLINDONE HYDROCHLORIDE
02 1MOLINDONE HYDROCHLORIDE USP
01 1Switzerland
02 3U.S.A
01 2Active
02 2Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7992
Submission : 1989-03-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10261
Submission : 1993-05-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19448
Submission : 2006-05-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20775
Submission : 2007-08-16
Status : Active
Type : II
A Molindone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Molindone, including repackagers and relabelers. The FDA regulates Molindone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Molindone 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 Molindone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Molindone supplier is an individual or a company that provides Molindone active pharmaceutical ingredient (API) or Molindone finished formulations upon request. The Molindone suppliers may include Molindone API manufacturers, exporters, distributors and traders.
click here to find a list of Molindone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Molindone DMF (Drug Master File) is a document detailing the whole manufacturing process of Molindone active pharmaceutical ingredient (API) in detail. Different forms of Molindone DMFs exist exist since differing nations have different regulations, such as Molindone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Molindone DMF submitted to regulatory agencies in the US is known as a USDMF. Molindone USDMF includes data on Molindone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Molindone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Molindone suppliers with USDMF on PharmaCompass.
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