Lupin has got EIR report from USFDA on inspection closure
Lupin, the pharma major has got an establishment inspection report (EIR) from the USFDA on closure of inspection of its Mandideep and Aurangabad facilities. Lupin...
Tag : USFDA
Glenmark has received 3 observations from USFDA for Indore plant
Three observations have been received by Glenmark Pharmaceuticals from the US health regulator for its Pithampur, Indore plant. The company, however said that it has...
Sri Krishna Pharma has been warned by USFDA, citing drug-data manipulation
The US Food and Drug Administration (FDA) has warned Sri Krishna Pharmaceuticals that supplies paracetamol and other drugs to more than 60 countries. The company...
Glenmark has received two ANDA approvals from USFDA
Glenmark Pharma said that it has got the US health regulator USFDA’s final approval for oral contraceptives and leukemia treatment injection. It said in a...
Glenmark has received final approval from USFDA for migraine headache relief drug
The USFDA has provided its approval to Glenmark Pharma for manufacturing and marketing therapeutical equivalent of Endo Pharmaceutical’s Frova tablets that are used to treat...
USFDA has rejected 11,664 products since January 2011 says Nirmala Sitharaman
Between January 2011 and February 2016, the US health regulator has refused entry of 11, 664 Indian products including drugs into the American market. Minister...
USFDA has given a warning letter to Dr Reddy’s for three drug plants
The US Food and Drug Administration has given a warning letter to Dr Reddy’s Laboratories Ltd over inadequate quality control procedures at three manufacturing plants...
Glenmark has got USFDA’s tentative approval for Lacosamide tablets
On Friday, Glenmark Pharmaceuticals said that it has got tentative approval from the US health regulator for its Lacosamide tablets. The company said in a...
Aurbindo get USFDA approval for Alzheimer’s treatment drug
On Thursday, the drug major, Aurobindo Pharma said that the USFDA has given its final approval to the company for the manufacture and market Memantine...
Unichem has received USFDA approval for generic asthma treatment tablets
Unichem Laboratories has got approval from the US health regulator for its Montelukast Sodium tablets that are used in prevention and chronic treatment of asthma....