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Biocon receives EIR from US FDA expressbpd
November 22, 2017
Biotechnology firm Biocon has received the Establishment Inspection Report (EIR) with ’voluntary action indicated’ status from the US FDA on closure of inspection of its aseptic drug product facility.
Glenmark receives US FDA approval for HAILEYTM 24 Fe 1 mg/ 20 mcg expressbpd
November 21, 2017
Glenmark’s current portfolio consists of 128 products authorised for distribution in the US marketplace and 59 ANDA’s pending approval with the US FDA.
Zydus Cadila gets US FDA nod for drug used to reduce swelling expressbpd
November 20, 2017
Zydus Cadila has received final approval from the US health regulator to market Ethacrynate sodium for injection, used to reduce swelling caused by various diseases.
Lupin receives US FDA warning letters expressbpd
November 08, 2017
Lupin’s formulation manufacturing facilities at Goa and Indore (Pithampur Unit II) has received warning letter from the US FDA.
Cipla’s US Subsidiary receives US FDA for generic Renvela tabs expressbpd
October 27, 2017
The tablets are indicated for the control of serum phosphorus in adults with chronic kidney disease (CKD) on dialysis
Dr Reddy’s Srikakulam unit clears US FDA audit expressbpd
September 29, 2017
The US Food and Drug Administration (US FDA) has cleared pharma major Dr Reddy’s Laboratories Ltd’s formulation Srikakulam Plant (SEZ) Unit I in Andhra Pradesh from its recent audit.
Orchid Pharma gets EIR from US FDA for its Alathur facility expressbpd
September 25, 2017
Orchid Pharma has received establishment inspection report (EIR) from the US health regulator for its Alathur facility in Tamil Nadu.
Zydus’ Nesher Pharma gets US FDA nods for influenza drug expressbpd
September 19, 2017
The drug will be produced at Nesher Pharmaceuticals manufacturing facility located at St Louis, US
Lupin gets US FDA nod to market generic anti-bacterial drug expressbpd
September 14, 2017
Drug maker Lupin has received a US health regulator’s nod to market generic version of Flagyl tablets, a drug used to treat bacterial infections, in the American market.
Zydus receives US FDA approval for Temozolomide capsules and Nadolol tablets expressbpd
August 03, 2017
Both drugs to be manufactured at the company’s formulations manufacturing facility at the Pharma SEZ, Ahmedabad

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