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FDA INSPECTION CLASSIFICATION
Lupin receives USFDA EIR for Goa facility with VAI statusDrug maker Lupin said it has received an Establishment Inspection Report from the US Food and Drug Administration for its Goa-based manufac...- US FDA issues 'Official Action Indicated' status to Sun Pharma’s Baska facility after inspectionSun Pharmaceutical Industries Ltd announced that its Baska manufacturing facility has been classified as Official Action Indicated (OAI) by...
- Sun Pharma shares in focus after USFDA flags ‘official action indicated’ status for Halol facilitySun Pharma shares: The company revealed that the FDA classified its Halol facility as “Official Action Indicated” after finding CGMP violat...
- Zydus Lifesciences shares in focus after Ahmedabad oncology injectable plant gets two FDA observationsZydus Lifesciences shares: The follow-up audit, conducted under Good Manufacturing Practices (GMP), took place from June 9 to June 18, 2025...
- HSBC sees Biocon share price rallying up to Rs 430; stock surges 5%Biocon Ltd shares rose 4.7% after HSBC upgraded its rating to "buy" and raised the target price to Rs 430. The upgrade reflects a turnaroun...
- Jubilant gets VAI classification from USFDA for Roorkee unitAs per the USFDA, a VAI inspection classification indicates that although investigators found and documented objectionable conditions durin...
- Torrent Pharma says US FDA issues 'EIR' for company's manufacturing facilityTorrent Pharmaceuticals on Thursday said that the US Food and Drug Administration (US FDA) has issued an Establishment Inspection Report (“...
- USFDA issues Form-483 with two observations for Lupin's Nagpur plantLupin's Nagpur facility has received two observations from the USFDA through Form-483 due to violations of the Food Drug and Cosmetic (FD&C...
- Lupin receives EIR from USFDA for its Goa manufacturing site, shares gainLupin said USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI), which means USFDA w...
- Lupin shares jump 10% in a sudden move; here's whyThe US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI), the Mumbai-headquartered ...
- Aurobindo Pharma gets VAI classification from USFDA for Hyderabad unitAs per the USFDA, a VAI inspection classification indicates that although investigators found and documented objectionable conditions durin...
- Biocon gets EIR from USFDA for manufacturing facility in BengaluruBiocon on Friday said it has received the establishment inspection report (EIR) from US health regulator for the post-approval and good man...
- USFDA cautions Aurobindo Pharma's oral solids formulation facility of regulatory actionAccording to USFDA's definitions, OAI means "objectionable conditions were found and regulatory administrative sanctions by FDA are indicat...
- USFDA classifies inspection of Lupin's Tarapur facility as 'Official Action Indicated'According to FDA's definitions, Official Action Indicated means "objectionable conditions were found and regulatory administrative sanction...
- Zydus Cadila gets EIR from USFDA for Ankleshwar facilityThe company's active pharmaceutical ingredient (API) manufacturing facility located at Ankleshwar (unit 1), Gujarat has received an Establi...
- US FDA seeks voluntary action on Dadra plant in relief for SunSun Pharma's shares had fallen last week over this development as investors worried about delay in product launches from the company.
- Aurobindo Pharma gains 2% as USFDA grants VAI to Hyderabad Unit IV; ends flatThe classification suggested that the matter has not escalated to the extent of slapping warnings letter or import alert.
- USFDA becoming dreaded word in Dalal Street; pharma companies need to keep Street in the loopThe stock of drug major Dr Reddy’s Labs (DRL) crashed 22% in the last three days, swiftly eroding the gains made over the last five months.
- With profit halved in Q2, it may take a while for Sun Pharma to come out of shadowsLower sales growth, supply constraints and currency movements in emerging markets dented second-quarter earnings at Sun Pharmaceutical Indu...
- Sun Pharma, Wockhardt recall drugs from US marketSun Pharma initiated voluntary recall of Bupropion Hydrochloride Extended-¬release Tablets USP (SR), while Wockhardt started recalling its ...
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