Granules India receives EIR for Vizag OmniChem faclitiy from USFDA
Granules India, has received Establishment Inspection Report(EIR), for the OmniChem facility at Vizag, Andhra Pradesh, from the US health regulator. In a BSE filing it...
Tag : USFDA
Zydus receives USFDA approval for overactive bladder drug
Zydus Cadila,has received final approval from US health regulator for marketing capsules, which are used in treating overactive bladder with symptoms like urinary frequency. In...
Natco partner’s multiple sclerosis injection receives USFDA approval
The US Food and Drug Administration(USFDA), has given approval to Natco Pharma’s marketing partner,Mylan’s Glatiramer Acetate injection used for treating relapsing forms of multiple sclerosis(MS)....
Glenmark Pharma gets USFDA approval for skin lotion
Glenmark Pharmaceuticals, receives final approval from the US health regulator for Desonide lotion which is used for skin rashes and irritation. In a regulatory filing...
Orchid Pharma receives EIR from USFDA
Orchid Pharma received establishment inspection report (EIR) from the US health regulator for its Alathur facility in Tamil Nadu. Orchid Pharma in a filing to...
Strides Shasun receives USFDA approval for lipid lowering drug
Strides Shasun,drug firm gets an approval from the United States health regulator for generic Omega-3-acid ethyl esters softgel capsules which will be used for reducing lipid...
Glenmark receives approval of USFDA for generic skin ointment
Glenmark Pharmaceuticals has got an approval from US health regulator to market Desonide Ointment, to treat skin problems,in the American market. According to company’s statement,...
Dr Reddy’s gets 3 observations from USFDA for its UK facility
The US health regulator has made three observations to Dr Reddy’s Laboratories UK facility after inspecting it. In a regulatory filing, Dr Reddy’s said that...
Lupin receives USFDA approval to market generic anti-bacterial drug
The US health regulator has provided its approval to the pharma major Lupin for marketing generic version of Flagyl tablets which is used in treating...
USFDA hikes generic filing fee by over 100 percent
From October, the Indian drug makers will have to pay more for generic filings in the US as the US drug regulator has doubled the...