All posts tagged "US FDA"
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1.1KNewsLupin’s Pithampur facility inspection concluded by US FDA without any observations
Pharma major Lupin Limited (Lupin) announced today the successful completion of a GMP inspection as well as a PAI inspection (Prior Approval...
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Lupin’s Goa facility inspection concluded by US FDA without any observations
Pharma major Lupin Limited (Lupin) announced today the successful completion of a PAI inspection (Prior Approval Inspection) carried out by the US...
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Sun Pharma Announces US FDA Filing Acceptance of Biologics License Application (BLA) For Tildrakizumab
Tildrakizumab is being evaluated for treatment of moderate-to-severe plaque psoriasis Sun Pharmaceutical Industries Ltd (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE:...
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Ajanta Pharma net up by 4.6% in Q4, second interim dividend of 350%
Ajanta Pharma’s consolidated net profit improved only by 4.6 per cent during the fourth quarter ended March 2017 to Rs.114 core from...
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USFDA lifts import alert from Sun Pharma’s Mohali plant
Sun Pharma said the US FDA will lift the import alert imposed on the Mohali (Punjab) manufacturing facility and remove the facility...
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Ajanta Pharma introduces generic Azor tablets in US market
Ajanta Pharma Limited, announced US FDA approval and launch of amlodipine + olmesartan medoxomil tablets in the US market through its wholly...
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Shilpa Medicare gets US FDA approval azacitidine injection
Shilpa Medicare, a Rs.625 crore Hyderabad based pharma major, has received US FDA approval for azacitidine injection. The company is producing this...
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Alembic receives US FDA approval for gout drug febuxostat
Alembic Pharmaceuticals Ltd has received tentative approval from the US Food & Drug Administration (FDA) for its abbreviated new drug application (ANDA)...
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Indoco Remedies receives US FDA approval
Indoco Remedies Ltd, a fully integrated, research- oriented pharma company, has received the Establishment Inspection Report (EIR) from US Food and Drug...
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Alembic Pharma gets US FDA approval for lacosamide tablets
Alembic Pharmaceuticals has received US FDA approval for lacosmide tablets, 50 mg, 100mg and 200 mg. The approved ANDA is therapeutically equivalent...
