Neuland Laboratories- A dedicated 100% API provider.
01 1Neuland Laboratories
02 1USV Private Limited
03 1Actavis Inc
04 1Alembic Pharmaceuticals Limited
05 1Cadila Pharmaceuticals
06 1Glenmark Life Sciences
07 1Ind Swift Laboratories Limited
08 1Orchid Pharma
09 1Torrent Pharmaceuticals Limited
10 1Urquima S.A. Grupo Uriach
11 1Zhejiang Huahai Pharmaceutical
01 2ROPINIROLE HYDROCHLORIDE
02 1ROPINIROLE HYDROCHLORIDE (NON-STERILE BULK API)
03 1ROPINIROLE HYDROCHLORIDE DRUG SUBSTANCE
04 6ROPINIROLE HYDROCHLORIDE USP
05 1ROPINIROLE HYDROCHLORIDE, USP
01 1China
02 8India
03 1Ireland
04 1Spain
01 8Active
02 3Inactive
01 2Complete
02 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19590
Submission : 2006-07-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 19045
Submission : 2005-12-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
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Pay. Date :
DMF Number : 19780
Submission : 2006-09-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19933
Submission : 2006-08-18
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-11-16
Pay. Date : 2022-11-14
DMF Number : 20593
Submission : 2007-06-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-17
Pay. Date : 2023-01-13
DMF Number : 18564
Submission : 2005-07-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 21938
Submission : 2008-10-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18777
Submission : 2005-09-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17880
Submission : 2004-12-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20829
Submission : 2007-04-25
Status : Active
Type : II
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