Aurobindo Pharma gets USFDA approval for Azithromycin tablets
Aurobindo Pharma has received final approval to manufacture and market Azithromycin tablets, from the USFDA. The tablets are used for the treatment of patients with mild...
Tag : USFDA
Shilpa Medicare receives EIR from USFDA
Shilpa Medicare has received establishment inspection report (EIR), from United States Food and Drug Administration (USFDA). The company has received of EIR for both API manufacturing...
Cadila Healthcare receives USFDA nod for Deferasirox tablets
Cadila Healthcare has received approval from the US health regulator, for Deferasirox tablets for oral suspension in the strengths of 125 mg, 250 mg and 500...
Unichem Lab gets USFDA nod for Montelukast Chewable tablets
Unichem Laboratories has received final ANDA approval from the United States Food and Drug Administration (USFDA), to market in the US, its Montelukast Chewable tablets, 4 mg and...
Cadila Healthcare receives USFDA nod to market Nifedipine tablets
Cadila Healthcare has received final approval to market Nifedipine extended-release tablets USP in the strengths of 30 mg, 60 mg, and 90 mg, from the US...
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...
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...