TAPI offers customized CDMO Solutions for API development and manufacturing services.
01 1TAPI Technology & API Services
02 1Alembic Pharmaceuticals Limited
03 1Fresenius Kabi Oncology Limited
04 2Hetero Drugs
05 1MSN Laboratories
06 1Qilu Antibiotics Pharmaceutical Co., Ltd.
07 1Sun Pharmaceutical Industries Limited
01 6AFATINIB DIMALEATE
02 1AFATINIB DIMALEATE (FORM A)
03 1AFATINIB DIMALEATE MONOHYDRATE (FORM-R)
01 1China
02 6India
03 1Israel
01 7Active
02 1Inactive
01 6Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-28
Pay. Date : 2017-01-10
DMF Number : 31302
Submission : 2017-01-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-18
Pay. Date : 2017-06-27
DMF Number : 31848
Submission : 2017-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30927
Submission : 2016-12-31
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-30
Pay. Date : 2017-04-28
DMF Number : 31611
Submission : 2017-04-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37111
Submission : 2022-05-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-17
Pay. Date : 2017-03-24
DMF Number : 31285
Submission : 2016-12-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-21
Pay. Date : 2019-02-12
DMF Number : 33080
Submission : 2019-02-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-29
Pay. Date : 2017-04-28
DMF Number : 31515
Submission : 2017-05-31
Status : Active
Type : II
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