Chirogate is a professional Prostaglandin manufacturer.
01 1Chirogate International
02 1EUROAPI
03 1Kyowa Pharma Chemical Co Ltd
04 1Pfizer Inc
01 1DINOPROSTONE
02 1DINOPROSTONE (PROSTAGLANDIN E2)
03 1DINOPROSTONE DRUG SUBSTANCE
04 1DINOPROSTONE USP
01 1France
02 1Japan
03 1Taiwan
04 1U.S.A
01 4Active
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37975
Submission : 2023-04-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11563
Submission : 1995-07-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11274
Submission : 1994-12-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5202
Submission : 1984-01-03
Status : Active
Type : II
A Dinoprostone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dinoprostone, including repackagers and relabelers. The FDA regulates Dinoprostone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dinoprostone 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 Dinoprostone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dinoprostone supplier is an individual or a company that provides Dinoprostone active pharmaceutical ingredient (API) or Dinoprostone finished formulations upon request. The Dinoprostone suppliers may include Dinoprostone API manufacturers, exporters, distributors and traders.
click here to find a list of Dinoprostone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dinoprostone DMF (Drug Master File) is a document detailing the whole manufacturing process of Dinoprostone active pharmaceutical ingredient (API) in detail. Different forms of Dinoprostone DMFs exist exist since differing nations have different regulations, such as Dinoprostone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dinoprostone DMF submitted to regulatory agencies in the US is known as a USDMF. Dinoprostone USDMF includes data on Dinoprostone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dinoprostone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dinoprostone suppliers with USDMF on PharmaCompass.
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