A competent team of experienced Regulatory professionals manage reports and submissions that meet the most exacting standards of regulatory agencies in the world.
REGULATORY
MARKETS – APPROVALS / STATUS
United
States
Europe
Japan
Canada
DMFs
in CTD
Available
Amlodipine Besilate
USFDA approved
COS & EUGMP approved
DMF Registered
DMF filed
Yes
Amlodipine Maleate
--
DMF approved
--
DMF filed
Yes
Cetrizine Di HCl
USFDA approved
COS recd. from EDQM
--
DMF filed
Yes
Raloxifene HCl
DMF filed No. 21682, 5th June 08.
EUGMP approved
--
DMF filed
Yes
Clopidogrel Bisulphate
DMF filed
No. 21235 Jan 16, 08
EUGMP approved
--
DMF filed
Yes
Carbidopa
DMF being filed
COS application filed
--
--
Yes
Levo Cetrizine
USFDA approved
EUGMP approved
--
--
Yes
Amlodipine
Mesylate
--
--
--
--
Yes
Country
specific approvals
Russia
Amlodipine Besilate Ukrain & TunisiaAmlodipine
Besilate & Clopidogrel Bisulphate Korea
Amlodipine Maleate & Cetrizine
Di HCl Iran
Raloxifene HCl
