DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 2Dr. Reddy's Laboratories
02 1Sichuan Elixir Pharmaceuticals
03 1Granules India Limited
04 1Cipla
05 1F.I.S. Fabbrica Italiana Sintetici
06 1Hetero Drugs
07 1Hikma Pharmaceuticals
08 3MSN Laboratories
09 1Natco Pharma
10 1Shilpa Medicare
11 1Sichuan Xieli Pharmaceutical
12 1Sun Pharmaceutical Industries Limited
13 1Suzhou Lixin Pharmaceutical
14 2Teva API
15 1Teva Pharmaceutical Industries
16 2Zhejiang Jiuzhou Pharmaceutical
17 1Blank
01 4NILOTINIB
02 1NILOTINIB BUTANEDISULFONATE
03 1NILOTINIB D-TARTRATE
04 1NILOTINIB DIHYDROCHLORIDE DIHYDRATE
05 2NILOTINIB HYDROCHLORIDE
06 1NILOTINIB HYDROCHLORIDE (MONOHYDRATE)
07 1NILOTINIB HYDROCHLORIDE DIHYDRATE
08 1NILOTINIB HYDROCHLORIDE FORM ALPHA
09 5NILOTINIB 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 11India
03 3Israel
04 1Italy
05 1United Kingdom
06 1Blank
01 19Active
02 3Inactive
01 11Complete
02 11Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-16
Pay. Date : 2016-02-04
DMF Number : 30088
Submission : 2015-12-31
Status : Active
Type : II
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
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2022-09-15
Pay. Date : 2022-08-22
DMF Number : 37161
Submission : 2022-07-08
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 : 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 : 2014-08-13
Pay. Date : 2014-03-19
DMF Number : 28102
Submission : 2014-07-15
Status : Active
Type : II
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