PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
01 1PMC Isochem
02 3Hainan Poly Pharm
01 1TRIMEBUTINE MALEATE
02 2TRIMEBUTINE MALEATE DRUG SUBSTANCE
03 1TRIMEBUTINE MALEATE TABLETS
01 3China
02 1France
01 2Active
02 2Inactive
01 4Blank
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19765
Submission : 2006-09-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34948
Submission : 2020-06-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24203
Submission : 2010-08-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23725
Submission : 2010-04-14
Status : Inactive
Type : II
A Maleate, Trimebutine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Maleate, Trimebutine, including repackagers and relabelers. The FDA regulates Maleate, Trimebutine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Maleate, Trimebutine 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 Maleate, Trimebutine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Maleate, Trimebutine supplier is an individual or a company that provides Maleate, Trimebutine active pharmaceutical ingredient (API) or Maleate, Trimebutine finished formulations upon request. The Maleate, Trimebutine suppliers may include Maleate, Trimebutine API manufacturers, exporters, distributors and traders.
click here to find a list of Maleate, Trimebutine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Maleate, Trimebutine DMF (Drug Master File) is a document detailing the whole manufacturing process of Maleate, Trimebutine active pharmaceutical ingredient (API) in detail. Different forms of Maleate, Trimebutine DMFs exist exist since differing nations have different regulations, such as Maleate, Trimebutine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Maleate, Trimebutine DMF submitted to regulatory agencies in the US is known as a USDMF. Maleate, Trimebutine USDMF includes data on Maleate, Trimebutine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Maleate, Trimebutine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Maleate, Trimebutine suppliers with USDMF on PharmaCompass.
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