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,...
Tag : USFDA
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...
USFDA approves Zydus Cadila’s hypertension medicine Pindolol
On Tuesday, Zydus Cadila has said that it has got the final approval from the US health regulator for marketing Pindolol tablets that are used...
Zydus Cadila receives USFDA approval for blood pressure drug
Zydus Cadila has got the final approval from the US health regulator for marketing blood pressure drug, Tiadylt ER. Cadila Healthcare has said in a...
Glenmark gets USFDA final approval for anti-herpes drug
The US health regulator has provided its final approval to the Glenmark Pharmaceuticals for Acyclovir Ointment that is used in treating herpes virus. Glenmark Pharmaceuticals...