01 1Johnson & Johnson Innovative Medicine
02 1Maithri Drugs
03 1Reyoung pharmaceutical
04 1TOPHARMAN SHANDONG CO LTD
01 4DAPOXETINE HYDROCHLORIDE
01 2China
02 1India
03 1U.S.A
01 3Active
02 1Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17828
Submission : 2004-12-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34632
Submission : 2020-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38050
Submission : 2023-02-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37627
Submission : 2022-10-26
Status : Active
Type : II
A Dapoxetine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dapoxetine Hydrochloride, including repackagers and relabelers. The FDA regulates Dapoxetine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dapoxetine Hydrochloride 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 Dapoxetine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dapoxetine Hydrochloride supplier is an individual or a company that provides Dapoxetine Hydrochloride active pharmaceutical ingredient (API) or Dapoxetine Hydrochloride finished formulations upon request. The Dapoxetine Hydrochloride suppliers may include Dapoxetine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Dapoxetine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dapoxetine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Dapoxetine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Dapoxetine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Dapoxetine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dapoxetine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Dapoxetine Hydrochloride USDMF includes data on Dapoxetine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dapoxetine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dapoxetine Hydrochloride suppliers with USDMF on PharmaCompass.
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