Strides Shasun receives USFDA nod for Ibuprofen tablets
Strides Shasun’s wholly owned subsidiary Strides Pharma Global Pte Ltd has received final approval from the United States Food & Drug Administration (USFDA), for Ibuprofen tablets...
Tag : USFDA
Aurobindo Pharma gets USFDA approval to market Ibuprofen capsules
Aurobindo Pharma has received final approval to manufacture and market Ibuprofen capsules. The approval has been received from the US health regulator. In a BSE filing the...
Dr Reddy’s gets EIR for Medak units from USFDA
Dr Reddy’s Laboratories has received Establishment Inspection Report (EIR) for the company’s Medak units, from the US health regulator. The company stated the exchanges that, it has...
Aurobindo Pharma receives USFDA nod for Ertapenem injection
Aurobindo Pharma has received USFDA’s go ahead, for Ertapenem injection. Ertapenem injection is a generic equivalent of Merck Sharp & Dohme Corp’s Invanz injection and the...
Biocon’s Bengaluru Unit receives EIR from USFDA
Biocon has received Establishment Inspection Report (EIR), from the US health regulator for its manufacturing facility in Bengaluru. The EIR is received on closure of...
Cipla receives USFDA approval for generic HIV drug
Cipla has received approval to market Efavirenz tablets, from the US health regulator. The company stated that, it has received final approval from the United States...
Cadila Healthcare receives USFDA nod for Tadalafil tablets
Cadila Healthcare has received tentative approval to market Tadalafil tablets which are available in strengths of USP, 2.5 mg, 5 mg, 10 mg and 20 mg, from...
Glenmark Pharma gets USFDA nod for Monroe facility
The US Food & Drug Administration (USFDA) has given its first supplemental abbreviated new drug applications (ANDA) approval, to the Glenmark Pharma’s manufacturing facility in Monroe, North...
Strides Shasun gets USFDA approval for Ketoconazole tablets USP
Strides Shasun’s wholly owned subsidiary, Strides Pharma Global Pte has received final approval from the United States Food & Drug Administration (USFDA), for Ketoconazole tablets...
USFDA approves Lupin’s contraceptive tablets
Lupin has received approval from USFDA for its pregnancy prevention tablets. The company has received final approval for its Drospirenone, Ethinyl Estradiol, Levomefolate Calcium Tablets...