Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
01 2Sichuan Elixir Pharmaceuticals
02 3Dr. Reddy's Laboratories
03 1Biocon
04 2MSN Laboratories
05 1Natco Pharma
06 1Sun Pharmaceutical Industries Limited
01 3CABOZANTINIB (S)-MALATE
02 1CABOZANTINIB (S)-MALATE (FORM N-2)
03 1CABOZANTINIB (S)-MALATE (FORM-S)
04 1CABOZANTINIB HYDROCHLORIDE
05 1CABOZANTINIB INTERMEDIATE (CZT3)
06 1CABOZANTINIB SULFATE
07 1CABOZANTINIB-(S)-MALATE
08 1CABOZANTINIB-S-MALATE
01 2China
02 8India
01 10Active
01 5Complete
02 5Blank
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 : 39757
Submission : 2024-03-22
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38207
Submission : 2023-03-31
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 : 39785
Submission : 2024-03-26
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39141
Submission : 2023-12-01
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39274
Submission : 2023-12-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-06
Pay. Date : 2023-03-08
DMF Number : 38057
Submission : 2023-09-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-06-25
Pay. Date : 2019-04-22
DMF Number : 33137
Submission : 2018-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-08
Pay. Date : 2017-05-22
DMF Number : 31522
Submission : 2017-03-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-23
Pay. Date : 2022-02-28
DMF Number : 36509
Submission : 2022-02-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-12-17
Pay. Date : 2019-10-11
DMF Number : 34201
Submission : 2019-11-06
Status : Active
Type : II
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