FDA approves new breakthrough therapy for cystic fibrosis
Treatment approved for approximately 90 per cent of patients with cystic fibrosis, many of whom had no approved therapeutic…
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Browsing Tag
US FDA
Lupin’s Nagpur facility receives EIR from the US FDA
The inspection for the oral solid facility at Nagpur closed without any Form 483 observation
Indoco’s Clinical Research Organisation receives zero 483s from US FDA
The company also recently successfully concluded an audit by US FDA at its sterile manufacturing facility in Goa (Plant II)
US FDA red flags Glenmark over batch failure investigations at Baddi facility
The United States Food and Drug Administration (US FDA) also warned the firm that until it corrects all violations, it may…
Slaying GMP non-compliance woes
Multiple warning letters call for renewed rigour to fix recurring lapses and instil a stronger quality compliance system
Eli Lilly’s migraine treatment wins US FDA approval
The drug has been approved to treat acute migraine with or without aura, a sensory phenomenon or visual disturbance, in adults
Torrent Pharma stock loses 3 per cent on US FDA warning letter
Stock of the drug firm was down 2.61 per cent at Rs 1,622.60 on the BSE
Documents potentially misleading in Aurobindo Pharma’s Unit-VII: US FDA
Several lists of documents requested were either provided as incomplete, inaccurate and or explained with potentially misleading…
Torrent Pharma gets warning letter from US FDA for Gujarat facility
The company is committed in maintaining the highest standards of compliances and quality manufacturing across all its facilities…
Glenmark receives ANDA approval for Dimethyl Fumarate Delayed-Release capsules
The drug is indicated to treat relapsing forms of multiple sclerosis
Glenmark Pharmaceuticals has been granted tentative…