Minakem is manufacturing small molecules APIs including corticosteroids
01 1Minakem (formerly Delmar Chemicals)
02 1Granules India Limited
03 2Alembic Pharmaceuticals Limited
04 1Aurobindo Pharma Limited
05 1Chongqing Carelife Pharmaceutical
06 3Cipla
07 1Hetero Drugs
08 3MSN Laboratories
09 2Natco Pharma
10 1Reliance Life Sciences Private Limited
11 1Sichuan Xieli Pharmaceutical
12 1Teva API
13 1Yabao Pharmaceutical Group Co. Ltd
14 1Zhejiang Jiuzhou Pharmaceutical
01 1SORAFENIB
02 1SORAFENIB HEMITOSYLATE
03 8SORAFENIB TOSYLATE
04 1SORAFENIB TOSYLATE (FORM 1)
05 1SORAFENIB TOSYLATE (FORM-I)
06 1SORAFENIB TOSYLATE (FORM-III) [ROUTE CODE "SR"]
07 1SORAFENIB TOSYLATE (VERSION NO.: 1)
08 1SORAFENIB TOSYLATE 3
09 4SORAFENIB TOSYLATE USP
10 1SORAFENIB TOSYLATE USP (FORM-I)
01 1Canada
02 4China
03 14India
04 1Israel
01 16Active
02 4Inactive
01 10Complete
02 10Blank
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-27
Pay. Date : 2018-01-19
DMF Number : 32140
Submission : 2017-12-20
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 : 37229
Submission : 2022-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-01-26
Pay. Date : 2015-11-19
DMF Number : 29941
Submission : 2015-11-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-22
Pay. Date : 2018-07-23
DMF Number : 32840
Submission : 2018-07-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-19
Pay. Date : 2016-08-18
DMF Number : 30235
Submission : 2016-01-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-22
Pay. Date : 2016-09-30
DMF Number : 30180
Submission : 2016-01-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-09
Pay. Date : 2014-02-25
DMF Number : 26693
Submission : 2012-12-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28556
Submission : 2014-09-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-01
Pay. Date : 2016-02-01
DMF Number : 30234
Submission : 2016-02-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-18
Pay. Date : 2015-06-12
DMF Number : 29340
Submission : 2015-06-30
Status : Active
Type : II
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