01 1GSK
02 1Nippon Kayaku
03 1Shanghai Hegno Pharmaceutical
04 1Shanghai Pharmaceuticals Holding Co.,Ltd
05 1Shanghai Zhonghua Pharmaceutical
06 2Wyeth Pharmaceuticals Inc
01 5GRISEOFULVIN
02 1GRISEOFULVIN USP MICROCRYSTALLINE
03 1GRISEOFULVIN, USP
01 3China
02 1Japan
03 2U.S.A
04 1United Kingdom
01 1Active
02 6Inactive
01 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13338
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13582
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18051
Submission : 2005-02-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16846
Submission : 2003-09-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15899
Submission : 2002-03-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13343
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13342
Submission : 1998-09-01
Status : Inactive
Type : II
A Griseofulvin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Griseofulvin, including repackagers and relabelers. The FDA regulates Griseofulvin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Griseofulvin 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 Griseofulvin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Griseofulvin supplier is an individual or a company that provides Griseofulvin active pharmaceutical ingredient (API) or Griseofulvin finished formulations upon request. The Griseofulvin suppliers may include Griseofulvin API manufacturers, exporters, distributors and traders.
click here to find a list of Griseofulvin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Griseofulvin DMF (Drug Master File) is a document detailing the whole manufacturing process of Griseofulvin active pharmaceutical ingredient (API) in detail. Different forms of Griseofulvin DMFs exist exist since differing nations have different regulations, such as Griseofulvin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Griseofulvin DMF submitted to regulatory agencies in the US is known as a USDMF. Griseofulvin USDMF includes data on Griseofulvin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Griseofulvin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Griseofulvin suppliers with USDMF on PharmaCompass.
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