01 1C-Squared Pharma
02 2CARBOGEN AMCIS AG
03 1OKAMI CHEMICAL INDUSTRY CO LTD
04 1Santen Pharmaceutical
05 1Shiono Finesse
06 1TOKYO KASEI KOGYO CO LTD
07 1UQUIFA
01 6TROPICAMIDE
02 1TROPICAMIDE MYDRIATIC
03 1TROPICAMIDE USP
01 1Ireland
02 4Japan
03 1Spain
04 2Switzerland
01 3Active
02 5Inactive
01 2Complete
02 6Blank
GDUFA
DMF Review : Complete
Rev. Date : 2023-04-18
Pay. Date : 2023-02-28
DMF Number : 37987
Submission : 2023-01-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12596
Submission : 1997-07-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6006
Submission : 1985-09-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14743
Submission : 2000-02-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5257
Submission : 1983-05-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14940
Submission : 2000-07-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10981
Submission : 1994-07-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-02
Pay. Date : 2014-05-27
DMF Number : 17800
Submission : 2004-10-15
Status : Active
Type : II
A Tropicamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tropicamide, including repackagers and relabelers. The FDA regulates Tropicamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tropicamide 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 Tropicamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tropicamide supplier is an individual or a company that provides Tropicamide active pharmaceutical ingredient (API) or Tropicamide finished formulations upon request. The Tropicamide suppliers may include Tropicamide API manufacturers, exporters, distributors and traders.
click here to find a list of Tropicamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tropicamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Tropicamide active pharmaceutical ingredient (API) in detail. Different forms of Tropicamide DMFs exist exist since differing nations have different regulations, such as Tropicamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tropicamide DMF submitted to regulatory agencies in the US is known as a USDMF. Tropicamide USDMF includes data on Tropicamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tropicamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tropicamide suppliers with USDMF on PharmaCompass.
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