Biocon receives EIR for its Bommansandra facility
The inspection was carried out from January 20-24, 2020
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US FDA
US FDA approves Retevmo for lung, thyroid cancers with certain genetic mutations
It is the first therapy approved specifically for cancer patients with the RET gene alterations
Dr Reddy’s gets EIR from USFDA for Srikakulam plant
All facilities under warning letter are now determined as ‘voluntary action indicated’
Alembic Pharma gets VAI classification from USFDA for Panelav facility
The US FDA inspection was conducted from March 9-13, 2020
US FDA gives EUA to Roche for COVID-19 antibody test
The company aims to more than double production of tests from about 50 million a month to significantly more than 100 million a…
US FDA issues EUA for remdesivir for COVID-19 treatment
The EUA allows for remdesivir to be distributed in the US and administered intravenously by healthcare providers, as appropriate,…
Wockhardt’s QIDP status for WCK 6777 reflects unmet need and untapped market opportunity:…
WCK 6777 targets multidrug resistance bacterial infections where unmet need is high, translating to an untapped market…
Lupin’s Pithampur Unit-1 facility receives EIR from US FDA
The inspection for the facility was conducted by the US FDA between February 3, 2020 and February 11, 2020 and concluded with two…
Lupin Receives Tentative Approval for Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 mL
Arformoterol Tartrate Inhalation Solution 15 mcg (base)/2 mL, Unit-dose Vials are indicated for the long-term maintenance…
Dr Reddy’s launches generic lipid-regulating tablets in US
The product is a generic version of AbbVie Inc's Tricor tablets