01 1Johnson & Johnson Innovative Medicine
02 1Sri Krishna Pharmaceuticals
01 1DOMPERIDONE (RESEARCH CODE R-33812)
02 1DOMPERIDONE PH EUR
01 1India
02 1U.S.A
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5402
Submission : 1984-05-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24424
Submission : 2010-12-13
Status : Active
Type : II
A Domperidone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Domperidone, including repackagers and relabelers. The FDA regulates Domperidone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Domperidone 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 Domperidone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Domperidone supplier is an individual or a company that provides Domperidone active pharmaceutical ingredient (API) or Domperidone finished formulations upon request. The Domperidone suppliers may include Domperidone API manufacturers, exporters, distributors and traders.
click here to find a list of Domperidone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Domperidone DMF (Drug Master File) is a document detailing the whole manufacturing process of Domperidone active pharmaceutical ingredient (API) in detail. Different forms of Domperidone DMFs exist exist since differing nations have different regulations, such as Domperidone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Domperidone DMF submitted to regulatory agencies in the US is known as a USDMF. Domperidone USDMF includes data on Domperidone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Domperidone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Domperidone suppliers with USDMF on PharmaCompass.
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