Dr Reddy’s gets four observations from USFDA for Srikakulam plant Press Trust of India Oct 28, 2019 The audit of the company's API Srikakulam Plant (SEZ) was completed last week
Aurobindo Pharma gets USFDA nod for its expectorant tablets Press Trust of India Oct 24, 2019 The tablets are the generic version of RB Health (US) LLC's Mucinex tablet, the company said
Dr Reddy’s recalls all its ranitidine products in US Press Trust of India Oct 23, 2019 The recall started on October 1 after USFDA found the presence of NDMA in certain ranitidine products above the permissable levels…
Alembic Pharma gets USFDA nod for ointment to treat various skin diseases Press Trust of India Oct 23, 2019 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 Press Trust of India Sep 26, 2019 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 Press Trust of India Sep 24, 2019 USFDA probing into the reported impurity N-nitrosodimethylamine in it at low levels
Dr Reddy’s launches heartburn capsules in US market Press Trust of India Sep 17, 2019 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 Press Trust of India Sep 9, 2019 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 Press Trust of India Sep 2, 2019 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 Press Trust of India Aug 30, 2019 The significant violations included the failure of the quality unit to ensure that quality-related complaints were investigated…