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...
Tag : USFDA
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...
Strides receives EIR from USFDA for Bengaluru facility
Strides Shasun has received an Establishment Inspection Report (EIR) from the US health regulator for its formulations facility at Bengaluru. Strides said in a BSE...
Hetero Labs gets USFDA’s warning letter for norm violations
A warning letter has been issued by the US health regulator to Hetero Labs for significant violations of good manufacturing norms at its facility in...
USFDA increases fee for processing ANDA by USD 1 lakh for FY18
The US Food and Drug Administration (USFDA) has has hiked fee for processing Abbreviated New Drug Application (ANDA) by over USD 1 lakh to USD...