US FDA concludes inspection of Unichem Lab’s Roha facility
The United States Food and Drug Administration (US FDA) conducted inspection at the company's active pharmaceutical ingredients…
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US FDA
LifeSan Clinical Research receives zero 483 observations from US FDA
The observation signifies compliance and conformance to applicable GCP regulations
LifeSan Clinical Research, the clinical…
Glenmark receives ANDA approval for Clobetasol Propionate Foam
The drug is indicated for the treatment of plaque psoriasis
Glenmark Pharmaceuticals, USA (Glenmark) has been granted final…
Lupin receives US FDA approval for Fosaprepitant Injection
The drug is indicated for the prevention of acute and delayed nausea and vomiting
Lupin has received approval for its…
Dr Reddy’s launches anti-smoking drug in USA market
The drug is a therapeutically equivalent generic version of Zyban which is indicated for treatment of nicotine dependence as an…
Laurus Labs receives EIR from US FDA for Visakhapatnam units
The company has also received approval from the Global Fund (GF) expert review panel for its fixed dose combination, TLE 400, for…
Purdue Pharma in discussion on $10 billion-$12 billion offer to settle opioid lawsuits: sources
Purdue is among several drugmakers and distributors that have been sued for fueling an opioid addiction crisis in the United…
US FDA grants orphan drug status to AstraZeneca’s asthma drug Fasenra
EoE, also known as allergic oesophagitis, is an allergic inflammation of the esophagus that involves a form of white blood cell,…
US FDA issues three observations to Ipca Laboratories Silvassa unit
In regulatory filing to BSE, Ipca Laboratories said US FDA conducted inspection of its formulations manufacturing unit from from…
Unichem’s Laboratories gets one observation from US FDA
The company will provide response, corrective action plan within next 15 working days