01 2Ono Pharmaceutical
01 1ALPROSTADIL ALFADEX
02 1ALPROSTADIL ALFADEX I.V.
01 2Japan
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27130
Submission : 2013-04-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10415
Submission : 1993-08-10
Status : Inactive
Type : II
A Alprostadil Alfadex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alprostadil Alfadex, including repackagers and relabelers. The FDA regulates Alprostadil Alfadex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alprostadil Alfadex 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 Alfadex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alprostadil Alfadex supplier is an individual or a company that provides Alprostadil Alfadex active pharmaceutical ingredient (API) or Alprostadil Alfadex finished formulations upon request. The Alprostadil Alfadex suppliers may include Alprostadil Alfadex API manufacturers, exporters, distributors and traders.
click here to find a list of Alprostadil Alfadex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alprostadil Alfadex DMF (Drug Master File) is a document detailing the whole manufacturing process of Alprostadil Alfadex active pharmaceutical ingredient (API) in detail. Different forms of Alprostadil Alfadex DMFs exist exist since differing nations have different regulations, such as Alprostadil Alfadex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alprostadil Alfadex DMF submitted to regulatory agencies in the US is known as a USDMF. Alprostadil Alfadex USDMF includes data on Alprostadil Alfadex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alprostadil Alfadex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alprostadil Alfadex suppliers with USDMF on PharmaCompass.
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