Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1ChemWerth Inc
03 1Biophore India Pharmaceuticals Pvt Ltd
04 1Apothecon Pharmaceuticals
05 1Aurobindo Pharma Limited
06 1Emcure Pharmaceuticals
07 1Hetero Drugs
08 1NerPharMa
09 1Olon S.p.A
10 1Shilpa Medicare
11 1Xian Libang Pharmaceutical Co.,Ltd
01 1MELPHALAN HCL, NON-STERILE, BULK DRUG SUBSTANCE
02 7MELPHALAN HYDROCHLORIDE
03 1MELPHALAN HYDROCHLORIDE (MPH)
04 1MELPHALAN HYDROCHLORIDE (NON STERILE BULK DRUG SUBSTANCE)
05 1MELPHALAN HYDROCHLORIDE DRUG SUBSTANCE
01 1China
02 1Germany
03 6India
04 2Italy
05 1U.S.A
01 10Active
02 1Inactive
01 10Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-21
Pay. Date : 2013-09-05
DMF Number : 25791
Submission : 2012-02-14
Status : Active
Type : II
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-21
Pay. Date : 2012-11-21
DMF Number : 25644
Submission : 2011-12-29
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-24
Pay. Date : 2013-09-25
DMF Number : 27485
Submission : 2013-09-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-18
Pay. Date : 2015-09-25
DMF Number : 29766
Submission : 2015-09-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-06-15
Pay. Date : 2022-06-03
DMF Number : 37179
Submission : 2022-06-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-07
Pay. Date : 2013-12-13
DMF Number : 25040
Submission : 2011-07-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-08
Pay. Date : 2016-09-21
DMF Number : 29537
Submission : 2015-07-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-18
Pay. Date : 2014-07-23
DMF Number : 27306
Submission : 2013-07-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-01
Pay. Date : 2015-05-22
DMF Number : 20883
Submission : 2007-09-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-04-23
Pay. Date : 2014-12-31
DMF Number : 28930
Submission : 2015-01-03
Status : Active
Type : II
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