ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Dr. Reddy's Laboratories
03 1Archimica
04 1Ash Stevens, Inc.
05 1Aurobindo Pharma Limited
06 1Hansoh Pharma
07 1Hetero Drugs
08 1ITF CHEMICAL LTDA
09 1Intas Pharmaceuticals
10 1Laurus Labs
11 1MSN Laboratories
12 1Polymed Therapeutics Inc.
13 1Qilu Antibiotics Pharmaceutical Co., Ltd.
14 1Reliance Life Sciences Private Limited
15 1ScinoPharm Taiwan, Ltd
16 1Shilpa Medicare
17 1Sun Pharmaceutical Industries Limited
18 1TAPI Technology & API Services
19 1Viatris
20 2Blank
01 15-AZACYTIDINE
02 15AZACITIDINE
03 1AZACITIDINE USP
04 1AZACITIDINE [ROUTE CODE "AJ"]
05 1AZACITIDINE, NON-STERILE BULK DRUG SUBSTANCE
06 1AZACYTIDINE
07 1BULK PREPARATION OF 5-AZACYTIDINE
01 1Brazil
02 2China
03 9India
04 1Israel
05 1Italy
06 1Taiwan
07 4U.S.A
08 2Blank
01 17Active
02 4Inactive
01 16Complete
02 5Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-26
Pay. Date : 2022-12-16
DMF Number : 23416
Submission : 2009-12-22
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 : 2020-11-20
Pay. Date : 2020-11-17
DMF Number : 23564
Submission : 2010-02-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-20
Pay. Date : 2013-12-27
DMF Number : 27821
Submission : 2013-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-27
Pay. Date : 2014-07-01
DMF Number : 27953
Submission : 2014-03-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-03
Pay. Date : 2013-02-07
DMF Number : 26846
Submission : 2013-02-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-05
Pay. Date : 2018-06-19
DMF Number : 28100
Submission : 2014-04-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-10-06
Pay. Date : 2016-08-10
DMF Number : 28107
Submission : 2014-03-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-04
Pay. Date : 2012-11-29
DMF Number : 22360
Submission : 2008-12-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-15
Pay. Date : 2013-09-23
DMF Number : 27487
Submission : 2013-09-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-24
Pay. Date : 2012-11-13
DMF Number : 26126
Submission : 2012-06-04
Status : Active
Type : II
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