Chirogate is a professional Prostaglandin manufacturer.
01 1Chirogate International
02 2R TECH UENO LTD
03 1Yonsung Fine Chemicals
01 1ISOPROPYL UNOPROSTONE
02 2UNOPROSTONE ISOPROPYL
03 1UNOPROSTONE ISOPROPYL OPHTHALMIC SOLUTION 0.15%
01 2Japan
02 1South Korea
03 1Taiwan
01 1Active
02 3Inactive
01 1Complete
02 3Blank
Chirogate is a professional Prostaglandin manufacturer.
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-20
Pay. Date : 2014-06-09
DMF Number : 28339
Submission : 2014-06-17
Status : Active
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 : 14611
Submission : 1999-12-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27235
Submission : 2013-06-11
Status : Inactive
Type : II
A Isopropyl Unoprostone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isopropyl Unoprostone, including repackagers and relabelers. The FDA regulates Isopropyl Unoprostone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isopropyl Unoprostone 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 Isopropyl Unoprostone supplier is an individual or a company that provides Isopropyl Unoprostone active pharmaceutical ingredient (API) or Isopropyl Unoprostone finished formulations upon request. The Isopropyl Unoprostone suppliers may include Isopropyl Unoprostone API manufacturers, exporters, distributors and traders.
click here to find a list of Isopropyl Unoprostone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isopropyl Unoprostone DMF (Drug Master File) is a document detailing the whole manufacturing process of Isopropyl Unoprostone active pharmaceutical ingredient (API) in detail. Different forms of Isopropyl Unoprostone DMFs exist exist since differing nations have different regulations, such as Isopropyl Unoprostone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isopropyl Unoprostone DMF submitted to regulatory agencies in the US is known as a USDMF. Isopropyl Unoprostone USDMF includes data on Isopropyl Unoprostone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isopropyl Unoprostone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Isopropyl Unoprostone suppliers with USDMF on PharmaCompass.
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