ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 2Aspen API
03 1Fareva
04 1Moehs Iberica
05 2Apothecon Pharmaceuticals
06 2Dishman Carbogen Amcis
07 1Emcure Pharmaceuticals
08 1Fresenius Kabi AB Brunna
09 1Fresenius Kabi Oncology Limited
10 1Jubilant Generics
11 1Mac-Chem Products (India) Pvt.Ltd
12 1Qilu Pharmaceutical
13 1Recipharm AB
01 2ROPIVACAINE
02 1ROPIVACAINE HCL MONOHYDRATE
03 4ROPIVACAINE HYDROCHLORIDE
04 1ROPIVACAINE HYDROCHLORIDE (NON STERILE, API)
05 2ROPIVACAINE HYDROCHLORIDE ANHYDROUS
06 2ROPIVACAINE HYDROCHLORIDE MONOHYDRATE
07 1ROPIVACAINE HYDROCHLORIDE MONOHYDRATE USP
08 2ROPIVACAINE HYDROCHLORIDE USP
09 1ROPIVACAINE HYDROCHLORIDE USP (PROCESS II)
01 1China
02 8India
03 1Luxembourg
04 2Netherlands
05 1Spain
06 2Sweden
07 1U.S.A
01 13Active
02 3Inactive
01 10Complete
02 6Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-13
Pay. Date : 2013-08-05
DMF Number : 20249
Submission : 2007-02-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-19
Pay. Date : 2016-11-18
DMF Number : 20654
Submission : 2007-07-03
Status : Active
Type : II
Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-22
Pay. Date : 2013-05-01
DMF Number : 18288
Submission : 2005-04-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-19
Pay. Date : 2021-04-23
DMF Number : 35568
Submission : 2021-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23239
Submission : 2009-11-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19084
Submission : 2005-12-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-19
Pay. Date : 2013-02-25
DMF Number : 25506
Submission : 2011-11-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-05
Pay. Date : 2013-04-01
DMF Number : 24948
Submission : 2011-10-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27027
Submission : 2013-04-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-21
Pay. Date : 2016-05-27
DMF Number : 25378
Submission : 2011-09-29
Status : Active
Type : II
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