EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1EUROAPI
02 1CASCADE BIOCHEMICAL LTD
03 1Everlight Chemical
04 1Evotec
05 1Nissan Chemical
06 2Ono Pharmaceutical
07 1TIEN (Tianjin) Pharmaceutical
01 5ALPROSTADIL
02 1PROSTAGLANDIN E
03 2PROSTAGLANDIN E1
01 1China
02 1France
03 1Germany
04 3Japan
05 1Taiwan
06 1United Kingdom
01 3Active
02 5Inactive
01 1Complete
02 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10948
Submission : 1994-06-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12569
Submission : 1997-07-02
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-06
Pay. Date : 2015-07-16
DMF Number : 21233
Submission : 2008-01-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13249
Submission : 1998-09-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11845
Submission : 1996-02-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21906
Submission : 2008-07-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11534
Submission : 1995-05-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34239
Submission : 2020-04-21
Status : Active
Type : II
A Prostaglandin E1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prostaglandin E1, including repackagers and relabelers. The FDA regulates Prostaglandin E1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prostaglandin E1 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 Prostaglandin E1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prostaglandin E1 supplier is an individual or a company that provides Prostaglandin E1 active pharmaceutical ingredient (API) or Prostaglandin E1 finished formulations upon request. The Prostaglandin E1 suppliers may include Prostaglandin E1 API manufacturers, exporters, distributors and traders.
click here to find a list of Prostaglandin E1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prostaglandin E1 DMF (Drug Master File) is a document detailing the whole manufacturing process of Prostaglandin E1 active pharmaceutical ingredient (API) in detail. Different forms of Prostaglandin E1 DMFs exist exist since differing nations have different regulations, such as Prostaglandin E1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prostaglandin E1 DMF submitted to regulatory agencies in the US is known as a USDMF. Prostaglandin E1 USDMF includes data on Prostaglandin E1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prostaglandin E1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prostaglandin E1 suppliers with USDMF on PharmaCompass.
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