Cadila has received EIR from USFDA for Changodar facility
Cadila Healthcare has got the Establishment Inspection Report (EIR) for its Changodar manufacturing plant that is located near Ahmedabad, from the US health regulator after...
Tag : USFDA
Alembic Pharma has received tentative approval from USFDA for Febuxostat
The US health regulator has provided its tentative approval to Alembic Pharmaceuticals for Febuxostat tablets that are used in the treatment of hyperuricemia in patients...
EIC, USFDA signs agreement to share information on import alerts
An agreement has been signed by the Export Inspection Council of India and the US health regulator for facilitating the sharing of information relating to...
Strides Shasun has received EIR report from USFDA
An Establishment Inspection Report (EIR) has been received by the drug firm Strides Shasun from the US health regulator on closure of inspection of its...
Strides receives tentative approval from USFDA for Roflumilast tablets
The US health regulator has given its tentative approval to Strides Shasun for Roflumilast tablets that are used in the treatment of inflammatory conditions of...
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...
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...