01 1DAITO CORP
02 1Lonza Inc & Lonza America Inc
03 1Recordati
04 1ScinoPharm Taiwan Ltd
05 1Yamamoto Corporation
06 2Blank
01 5FLAVOXATE HYDROCHLORIDE
02 1FLAVOXATE HYDROCHLORIDE JP XIII
03 1FLAVOXATE HYDROCHLORIDE JP14
01 1Italy
02 2Japan
03 1Taiwan
04 1U.S.A
05 2Blank
01 1Active
02 6Inactive
01 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16336
Submission : 2002-12-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4430
Submission : 1982-02-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6494
Submission : 1986-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15613
Submission : 2001-09-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13179
Submission : 1998-09-08
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8443
Submission : 1990-02-28
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6879
Submission : 1987-03-10
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
40
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A 27814-EP2314587A1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 27814-EP2314587A1, including repackagers and relabelers. The FDA regulates 27814-EP2314587A1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 27814-EP2314587A1 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 27814-EP2314587A1 DMF (Drug Master File) is a document detailing the whole manufacturing process of 27814-EP2314587A1 active pharmaceutical ingredient (API) in detail. Different forms of 27814-EP2314587A1 DMFs exist exist since differing nations have different regulations, such as 27814-EP2314587A1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 27814-EP2314587A1 DMF submitted to regulatory agencies in the US is known as a USDMF. 27814-EP2314587A1 USDMF includes data on 27814-EP2314587A1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 27814-EP2314587A1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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