Dr Reddy’s recalls all its ranitidine products in US
The recall started on October 1 after USFDA found the presence of NDMA in certain ranitidine products above the permissable levels…
Sign in
Sign in
Recover your password.
A password will be e-mailed to you.
Browsing Tag
USFDA
Alembic Pharma gets USFDA nod for ointment to treat various skin diseases
Alembic said it has a cumulative total of 104 abbreviated new drug application (ANDA) approvals from USFDA
Lupin gets 3 observations from USFDA for its Tarapur facility
The inspection of Tarapur facility was carried out by the United States Food and Drug administration (USFDA) between September…
Dr Reddy’s halts worldwide supply of ranitidine
USFDA probing into the reported impurity N-nitrosodimethylamine in it at low levels
Dr Reddy’s launches heartburn capsules in US market
The capsules are used for the treatment of frequent heartburn in the US market
The company has launched Lansoprazole…
Aurobindo Pharma recalls over 2k bottles of lipid-lowering tablets from US
The reason for recall is"labeling; incorrect or missing lot and/or exp date; some bottles labelled with lot number 05318054B…
USFDA issues response letter for new drug application for insulin glargine: Biocon
As per the USFDA, a Complete Response Letter (CRL) is sent to an applicant if the agency determines that it will not approve the…
USFDA pulls up Lantech Pharma for manufacturing violations at Andhra plant
The significant violations included the failure of the quality unit to ensure that quality-related complaints were investigated…
Glenmark Pharma gets USFDA nod for skin treatment ointment
The approved product is a generic version of Elidel Cream, one per cent, of Bausch Health US, LLC
FDA gives fast track status to AstraZeneca’s diabetes drug Farxiga
In July, the US regulators had declined to approve Farxiga as a supplement to insulin in adults with type-1 diabetes where insulin…