Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1Fareva
03 1Apicore LLC
04 1Archimica
05 1ChemPacific Corp
06 1DMFs Not Supported
07 2Emcure Pharmaceuticals
08 1Fresenius Kabi AB Brunna
09 1Shilpa Medicare
01 5BUSULFAN
02 1BUSULFAN DRUG SUBSTANCE
03 3BUSULFAN USP
04 1PREMIX FOR BUSULFAN (WITHOUT ACTIVE)
01 1Germany
02 4India
03 1Italy
04 1Luxembourg
05 1Sweden
06 1U.S.A
07 1Blank
01 7Active
02 3Inactive
01 6Complete
02 4Blank
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-08
Pay. Date : 2012-12-17
DMF Number : 25933
Submission : 2012-03-27
Status : Active
Type : II
Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-03
Pay. Date : 2014-07-10
DMF Number : 27006
Submission : 2013-06-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-10
Pay. Date : 2015-05-27
DMF Number : 23924
Submission : 2010-08-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25393
Submission : 2011-10-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21126
Submission : 2007-12-12
Status : Active
Type : II
USDMF
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-25
Pay. Date : 2012-11-21
DMF Number : 25667
Submission : 2012-02-02
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-29
Pay. Date : 2014-01-22
DMF Number : 25433
Submission : 2011-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25836
Submission : 2012-04-01
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24385
Submission : 2010-11-30
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-02
Pay. Date : 2012-12-19
DMF Number : 25491
Submission : 2011-12-07
Status : Active
Type : II
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