Veranova: A CDMO that manages complexity with confidence.
01 1Veranova
02 1Noramco
03 1Fujifilm Diosynth Biotechnologies
04 1Grunenthal
05 2Mallinckrodt Pharmaceuticals
06 2Siegfried AG
01 1EXTENDED-RELEASE OXYMORPHONE HYDROCHLORIDE TABLETS
02 1OXYMORPHONE HCL, USP
03 2OXYMORPHONE HYDROCHLORIDE
04 1OXYMORPHONE HYDROCHLORIDE DRUG SUBSTANCE
05 2OXYMORPHONE HYDROCHLORIDE USP
06 1OXYMORPHONE HYDROCHLORIDE USP (LOW ABUK IMPURITY)
01 1Germany
02 2Ireland
03 2Switzerland
04 2U.S.A
05 1United Kingdom
01 3Active
02 5Inactive
01 2Complete
02 6Blank
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21675
Submission : 2008-06-04
Status : Active
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-15
Pay. Date : 2012-11-23
DMF Number : 22816
Submission : 2009-06-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7451
Submission : 1988-04-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23754
Submission : 2010-04-29
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-12
Pay. Date : 2012-11-27
DMF Number : 14502
Submission : 1999-10-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9109
Submission : 1991-05-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25628
Submission : 2011-12-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23403
Submission : 2009-12-22
Status : Inactive
Type : II
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A Opana ER DMF (Drug Master File) is a document detailing the whole manufacturing process of Opana ER active pharmaceutical ingredient (API) in detail. Different forms of Opana ER DMFs exist exist since differing nations have different regulations, such as Opana ER USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Opana ER DMF submitted to regulatory agencies in the US is known as a USDMF. Opana ER USDMF includes data on Opana ER's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Opana ER USDMF is kept confidential to protect the manufacturer’s intellectual property.
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