Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1Taro Pharmaceutical Industries
03 1Aarti Pharmalabs
04 1Medichem S.A
05 1ALP Pharm
06 1Amino Chemicals
07 1Glenmark Life Sciences
08 1Helsinn Advanced Synthesis
09 1Maithri Drugs
10 1Olon S.p.A
11 1TAPI Technology & API Services
12 1Zhejiang Neo-Dankong Pharm. Co.,Ltd.
01 4ADAPALENE
02 1ADAPALENE (DRUG SUBTANCE NON-STERILE)
03 1ADAPALENE (MED-200025/E)
04 1ADAPALENE (NON-STERILE BULK DRUG SUBSTANCE)
05 1ADAPALENE DRUG SUBSTANCE
06 3ADAPALENE USP
07 1ADAPALENE USP, MICRONIZED
01 2China
02 1Germany
03 3India
04 1Israel
05 1Italy
06 1Malta
07 1Spain
08 1Switzerland
09 1U.S.A
01 9Active
02 3Inactive
01 5Complete
02 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8784
Submission : 1990-10-12
Status : Active
Type : II
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-30
Pay. Date : 2013-05-21
DMF Number : 22709
Submission : 2009-04-08
Status : Active
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-09
Pay. Date : 2013-04-25
DMF Number : 21480
Submission : 2008-03-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-07
Pay. Date : 2014-03-11
DMF Number : 21208
Submission : 2008-01-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-08
Pay. Date : 2012-11-26
DMF Number : 18756
Submission : 2005-09-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18826
Submission : 2005-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39063
Submission : 2023-10-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-12
Pay. Date : 2014-02-14
DMF Number : 19621
Submission : 2006-07-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20064
Submission : 2006-12-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18831
Submission : 2005-09-22
Status : Inactive
Type : II
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