01 1BIOSYN ARZNEIMITTEL GMBH
02 1Biosyn
03 2Blank
01 1SELENASE SOLUTION FOR INJECTION AND SELENASE ORAL SOLUTION DRUG PRODUCTS
02 1SELENIUM 5 MG TABLETS
03 1SELENIUM SE 75 MOSE
04 1SELENIUM-75
01 2Germany
02 2Blank
01 2Active
02 2Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21120
Submission : 2007-12-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27545
Submission : 2013-09-09
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3900
Submission : 1980-07-11
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1265
Submission : 1968-12-16
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Selenium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Selenium, including repackagers and relabelers. The FDA regulates Selenium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Selenium 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 Selenium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Selenium supplier is an individual or a company that provides Selenium active pharmaceutical ingredient (API) or Selenium finished formulations upon request. The Selenium suppliers may include Selenium API manufacturers, exporters, distributors and traders.
click here to find a list of Selenium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Selenium DMF (Drug Master File) is a document detailing the whole manufacturing process of Selenium active pharmaceutical ingredient (API) in detail. Different forms of Selenium DMFs exist exist since differing nations have different regulations, such as Selenium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Selenium DMF submitted to regulatory agencies in the US is known as a USDMF. Selenium USDMF includes data on Selenium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Selenium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Selenium suppliers with USDMF on PharmaCompass.
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