Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
01 1Centrient Pharmaceuticals
02 1Minakem (formerly Delmar Chemicals)
03 3TAPI Technology & API Services
04 2Amoli Organics
05 1Apotex Pharmachem
06 1Aurobindo Pharma Limited
07 2Biocon
08 1CTX Lifesciences
09 2Changzhou Pharmaceutical Factory
10 2Chromo Laboratories
11 2Glenmark Life Sciences
12 1HEC Pharm
13 1Hetero Drugs
14 1Innovare Labs
15 1Jubilant Generics
16 1KOLON Life Science, Inc
17 1Lee Pharma
18 3Lek Pharmaceuticals
19 1Lewens Labs
20 1Lupin Ltd
21 3MSN Laboratories
22 1Macleods Pharmaceuticals Limited
23 1Mankind Pharma
24 1Melody Healthcare Pvt Ltd
25 2Morepen Laboratories
26 1Ningbo Menovo Pharmaceutical
27 1Shanghai Desano Bio-Pharmaceutical
28 1Shanghai Wonder Pharmaceutical
29 1Sun Pharmaceutical Industries Limited
30 1Viatris
31 1ZHEJIANG MENOVO PHARMACEUTICAL CO., LTD. CN 312 369 Shangyu
32 1Zhejiang Hisun Pharmaceutical
33 1Zhejiang Neo-Dankong Pharm. Co.,Ltd.
34 1Zhejiang Yongtai Technology
35 1Zydus Lifesciences
01 20ROSUVASTATIN CALCIUM
02 1ROSUVASTATIN CALCIUM (AMORPHOUS)
03 1ROSUVASTATIN CALCIUM (BULK)
04 1ROSUVASTATIN CALCIUM (NON-STERILE DRUG SUBSTANCE)
05 1ROSUVASTATIN CALCIUM (PROCESS B)
06 1ROSUVASTATIN CALCIUM (PROCESS C)
07 1ROSUVASTATIN CALCIUM (PRODUCT CODE 8004368)
08 1ROSUVASTATIN CALCIUM (ROUTE CODE: RSF)
09 1ROSUVASTATIN CALCIUM AMORPHOUS
10 1ROSUVASTATIN CALCIUM NON-STERILE BULK DRUG SUBSTANCE
11 1ROSUVASTATIN CALCIUM PROCESS -2
12 1ROSUVASTATIN CALCIUM PROCESS G
13 1ROSUVASTATIN CALCIUM PROCESS G 2410
14 12ROSUVASTATIN CALCIUM USP
15 1ROSUVASTATIN CALCIUM USP [ROUTE CODE - "RT"]
16 1ROSUVASTATIN CALCIUM USP [ROUTE CODE - RV"]
17 1ROSUVASTATIN CALCIUM, NON- STERILE BULK DRUG SUBSTANCES
01 2Canada
02 10China
03 26India
04 3Israel
05 1Netherlands
06 3Slovenia
07 1South Korea
08 1U.S.A
01 40Active
02 7Inactive
01 26Complete
02 21Blank
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-17
Pay. Date : 2017-05-23
DMF Number : 31410
Submission : 2017-03-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-08
Pay. Date : 2015-09-25
DMF Number : 29190
Submission : 2015-12-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-31
Pay. Date : 2013-01-02
DMF Number : 20671
Submission : 2007-07-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-23
Pay. Date : 2016-08-29
DMF Number : 30830
Submission : 2016-12-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27879
Submission : 2014-02-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20629
Submission : 2007-06-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-05
Pay. Date : 2013-09-27
DMF Number : 20705
Submission : 2007-07-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20592
Submission : 2007-06-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20765
Submission : 2007-08-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-11
Pay. Date : 2013-07-03
DMF Number : 20712
Submission : 2007-07-25
Status : Active
Type : II
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