01 1Akron Biotech
02 1Biocell Laboratories
03 1Boval Company US 76031 Cleburne
04 1Bovogen Biologicals
05 1EMD Millipore Corporation
06 1Equitech-Bio, Inc. US 78028 Kerrville
07 1Irvine Scientific Sales Company
08 1LIFE TECHNOLOGIES CORPORATION US 92008 Carlsbad
09 1MP Biomedicals
10 1Moregate Biotech
11 1Moregate Exports Pty Ltd
12 2Proliant Biologicals
13 1ROCKY MOUNTAIN BIOLOGICALS
01 3Australia
02 1France
03 1India
04 9U.S.A
01 2Active
02 12Blank
01 12Valid
02 2Blank
01 14Blank
01 14Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33789
Submission : 2019-06-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28468
Submission : 2014-07-14
Status : Active
Type : II
Certificate Number : R1-CEP 2003-204 - Rev 00
Issue Date : 2009-04-06
Type : TSE
Substance Number :
Status : Valid
Certificate Number : R1-CEP 2009-010 - Rev 00
Issue Date : 2014-11-03
Type : TSE
Substance Number :
Status : Valid
Certificate Number : R1-CEP 2003-205 - Rev 01
Issue Date : 2020-10-14
Type : TSE
Substance Number :
Status : Valid
Certificate Number : R1-CEP 2005-191 - Rev 00
Issue Date : 2010-11-08
Type : TSE
Substance Number :
Status : Valid
Certificate Number : R1-CEP 2006-010 - Rev 00
Issue Date : 2011-05-25
Type : TSE
Substance Number :
Status : Valid
Certificate Number : R1-CEP 2000-195 - Rev 04
Issue Date : 2009-07-09
Type : TSE
Substance Number :
Status : Valid
Certificate Number : R1-CEP 2005-293 - Rev 02
Issue Date : 2014-04-22
Type : TSE
Substance Number :
Status : Valid
Certificate Number : R0-CEP 2020-162 - Rev 00
Issue Date : 2021-08-23
Type : TSE
Substance Number :
Status : Valid
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