Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Dr. Reddy's Laboratories
03 1Taro Pharmaceutical Industries
04 1Aurobindo Pharma Limited
05 1Cadila Pharmaceuticals
06 1Cambrex Corporation
07 1ChemSource
08 1Cipla
09 1Hikal
10 1Hikma Pharmaceuticals
11 1Ipca Laboratories
12 1NINGBO TEAM PHARMACEUTICAL CO., LTD. CN 315 201 Ningbo
13 2Natco Pharma
14 1Qilu Pharmaceutical
15 1SMS Pharmaceuticals
16 1ScinoPharm Taiwan, Ltd
17 1Sun Pharmaceutical Industries Limited
18 2TAPI Technology & API Services
01 2ONDANSETRON HCL
02 1ONDANSETRON HCL DIHYDRATE
03 1ONDANSETRON HCL USP
04 2ONDANSETRON HYDROCHLORIDE
05 1ONDANSETRON HYDROCHLORIDE (INJECTABLE GRADE)
06 1ONDANSETRON HYDROCHLORIDE (NON-STERILE API)
07 1ONDANSETRON HYDROCHLORIDE BULK FORM
08 1ONDANSETRON HYDROCHLORIDE DIHYDRATE
09 1ONDANSETRON HYDROCHLORIDE DIHYDRATE USP
10 8ONDANSETRON HYDROCHLORIDE USP
11 1ONDANSETRON HYDROCHLORIDE, USP
01 2China
02 10India
03 2Israel
04 1Spain
05 1Taiwan
06 3U.S.A
07 1United Kingdom
01 17Active
02 3Inactive
01 9Complete
02 11Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16317
Submission : 2002-12-13
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 : 2015-09-23
Pay. Date : 2015-09-09
DMF Number : 15436
Submission : 2001-05-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16976
Submission : 2003-11-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16786
Submission : 2003-09-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-10-23
Pay. Date : 2018-09-13
DMF Number : 15752
Submission : 2001-12-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15724
Submission : 2001-11-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-17
Pay. Date : 2021-08-12
DMF Number : 16710
Submission : 2003-07-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-02-25
Pay. Date : 2020-02-20
DMF Number : 15990
Submission : 2002-05-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16562
Submission : 2003-04-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15642
Submission : 2001-10-01
Status : Active
Type : II
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