Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
01 1Sichuan Elixir Pharmaceuticals
02 1Granules India Limited
03 1Cipla
04 1F.I.S. Fabbrica Italiana Sintetici
05 1Hetero Drugs
06 1Hikma Pharmaceuticals
07 3MSN Laboratories
08 1Natco Pharma
09 1Shilpa Medicare
10 1Sichuan Xieli Pharmaceutical
11 1Sun Pharmaceutical Industries Limited
12 1Suzhou Lixin Pharmaceutical
13 2Teva API
14 1Teva Pharmaceutical Industries
15 2Zhejiang Jiuzhou Pharmaceutical
16 1Blank
01 4NILOTINIB
02 1NILOTINIB BUTANEDISULFONATE
03 1NILOTINIB D-TARTRATE
04 1NILOTINIB DIHYDROCHLORIDE DIHYDRATE
05 1NILOTINIB HYDROCHLORIDE
06 1NILOTINIB HYDROCHLORIDE (MONOHYDRATE)
07 1NILOTINIB HYDROCHLORIDE DIHYDRATE
08 1NILOTINIB HYDROCHLORIDE FORM ALPHA
09 4NILOTINIB HYDROCHLORIDE MONOHYDRATE
10 1NILOTINIB HYDROCHLORIDE MONOHYDRATE (FORM B) (VERSION NO.: 1)
11 1NILOTINIB HYDROCHLORIDE MONOHYDRATE (VERSION NO.: 1)
12 1NILOTINIB HYDROCHLORIDE SESQUIHYDRATE
13 1NILOTINIB MONOHYDROCHLORIDE ANHYDROUS
14 1NILOTINIB TARTRATE
01 5China
02 9India
03 3Israel
04 1Italy
05 1United Kingdom
06 1Blank
01 17Active
02 3Inactive
01 9Complete
02 11Blank
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39648
Submission : 2024-03-27
Status : Active
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37531
Submission : 2022-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-20
Pay. Date : 2017-05-11
DMF Number : 31740
Submission : 2017-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-05
Pay. Date : 2016-05-05
DMF Number : 30098
Submission : 2015-12-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30164
Submission : 2015-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32661
Submission : 2018-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33196
Submission : 2018-09-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-06-04
Pay. Date : 2017-05-17
DMF Number : 31693
Submission : 2017-04-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-28
Pay. Date : 2020-05-13
DMF Number : 34874
Submission : 2020-07-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-13
Pay. Date : 2014-03-19
DMF Number : 28102
Submission : 2014-07-15
Status : Active
Type : II
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