Cayman Pharma is Europe's most reliable and versatile source for Prostaglandin APIs//FDA approved.
01 1Cayman Pharma s.r.o
02 1EUROAPI
03 1Everlight Chemical
04 1MSN Laboratories
05 1Pfizer Inc
06 1Sai Life Sciences Limited
07 1Sun Pharmaceutical Industries Limited
01 1EPOPROSTENAL SODIUM DRUG SUBSTANCE
02 3EPOPROSTENOL SODIUM
03 1EPOPROSTENOL SODIUM (U-53,217A)
04 1EPOPROSTENOL SODIUM [ROUTE CODE - ED]
05 1EPOPROSTENOL SODIUM, NON-STERILE
01 1Czech Republic
02 1France
03 3India
04 1Taiwan
05 1U.S.A
01 6Active
02 1Inactive
01 3Complete
02 4Blank
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-27
Pay. Date : 2019-09-13
DMF Number : 21584
Submission : 2008-04-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19539
Submission : 2006-06-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21311
Submission : 2008-02-05
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-26
Pay. Date : 2023-08-29
DMF Number : 27420
Submission : 2013-08-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6065
Submission : 1985-10-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19971
Submission : 2006-11-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-06
Pay. Date : 2016-02-23
DMF Number : 30263
Submission : 2017-01-07
Status : Active
Type : II
A Epoprostenol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Epoprostenol, including repackagers and relabelers. The FDA regulates Epoprostenol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Epoprostenol 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 Epoprostenol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Epoprostenol supplier is an individual or a company that provides Epoprostenol active pharmaceutical ingredient (API) or Epoprostenol finished formulations upon request. The Epoprostenol suppliers may include Epoprostenol API manufacturers, exporters, distributors and traders.
click here to find a list of Epoprostenol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Epoprostenol DMF (Drug Master File) is a document detailing the whole manufacturing process of Epoprostenol active pharmaceutical ingredient (API) in detail. Different forms of Epoprostenol DMFs exist exist since differing nations have different regulations, such as Epoprostenol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Epoprostenol DMF submitted to regulatory agencies in the US is known as a USDMF. Epoprostenol USDMF includes data on Epoprostenol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Epoprostenol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Epoprostenol suppliers with USDMF on PharmaCompass.
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