01 2R TECH UENO LTD
02 1Yonsung Fine Chemicals
01 1ISOPROPYL UNOPROSTONE
02 1UNOPROSTONE ISOPROPYL
03 1UNOPROSTONE ISOPROPYL OPHTHALMIC SOLUTION 0.15%
01 2Japan
02 1South Korea
01 3Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14611
Submission : 1999-12-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22987
Submission : 2009-07-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27235
Submission : 2013-06-11
Status : Inactive
Type : II
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A 13,14-Dihydro-15-keto-20-ethyl-PGF2 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 13,14-Dihydro-15-keto-20-ethyl-PGF2, including repackagers and relabelers. The FDA regulates 13,14-Dihydro-15-keto-20-ethyl-PGF2 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 13,14-Dihydro-15-keto-20-ethyl-PGF2 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 13,14-Dihydro-15-keto-20-ethyl-PGF2 supplier is an individual or a company that provides 13,14-Dihydro-15-keto-20-ethyl-PGF2 active pharmaceutical ingredient (API) or 13,14-Dihydro-15-keto-20-ethyl-PGF2 finished formulations upon request. The 13,14-Dihydro-15-keto-20-ethyl-PGF2 suppliers may include 13,14-Dihydro-15-keto-20-ethyl-PGF2 API manufacturers, exporters, distributors and traders.
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A 13,14-Dihydro-15-keto-20-ethyl-PGF2 DMF (Drug Master File) is a document detailing the whole manufacturing process of 13,14-Dihydro-15-keto-20-ethyl-PGF2 active pharmaceutical ingredient (API) in detail. Different forms of 13,14-Dihydro-15-keto-20-ethyl-PGF2 DMFs exist exist since differing nations have different regulations, such as 13,14-Dihydro-15-keto-20-ethyl-PGF2 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 13,14-Dihydro-15-keto-20-ethyl-PGF2 DMF submitted to regulatory agencies in the US is known as a USDMF. 13,14-Dihydro-15-keto-20-ethyl-PGF2 USDMF includes data on 13,14-Dihydro-15-keto-20-ethyl-PGF2's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 13,14-Dihydro-15-keto-20-ethyl-PGF2 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 2 companies offering 13,14-Dihydro-15-keto-20-ethyl-PGF2
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