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
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
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 Alprostadil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alprostadil, including repackagers and relabelers. The FDA regulates Alprostadil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alprostadil 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 Alprostadil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alprostadil supplier is an individual or a company that provides Alprostadil active pharmaceutical ingredient (API) or Alprostadil finished formulations upon request. The Alprostadil suppliers may include Alprostadil API manufacturers, exporters, distributors and traders.
click here to find a list of Alprostadil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alprostadil DMF (Drug Master File) is a document detailing the whole manufacturing process of Alprostadil active pharmaceutical ingredient (API) in detail. Different forms of Alprostadil DMFs exist exist since differing nations have different regulations, such as Alprostadil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alprostadil DMF submitted to regulatory agencies in the US is known as a USDMF. Alprostadil USDMF includes data on Alprostadil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alprostadil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alprostadil suppliers with USDMF on PharmaCompass.
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