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OAI
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...
- USFDA classifies Zydus Lifesciences Jarod unit as 'official action indicated'Zydus Lifesciences Ltd has been classified as "official action indicated" by the US Food and Drug Administration (FDA) for its Jarod inject...
- India pharma units fare better in US checks in 2023The drug regulator United States Food and Drug Administration (USFDA) has classified 13%, or 19 out of 145 inspections it carried out again...
- Biocon Biologics' Malaysia insulin facility classified by US FDA for official actionBiocon Biologics has announced that its insulin manufacturing facility in Johor, Malaysia has been classified as an official action indicat...
- US drug regulator resumes surprise inspections in India"In terms of (inspection) activity (in India) we are getting closer to pre-pandemic levels," Sarah McMullen, country director - India at US...
- Glenmark gets OAI classification from USFDA for Monroe site"The OAI classification implies inter‐alia that the USFDA may withhold approval of any pending product applications or supplements filed fr...
- View: Virtual quality control's ours to techAnd for good reasons. As of June 2021, the FDA had a backlog of over 2,500 foreign inspections, including nearly 500 and 400 in India and C...
- Sun Pharma drops 3% as USFDA initiates action against Halol facilityUSFDA inspected the facility from December 3 to December 13 and had issued eight observations, the company had earlier said in a regulatory...
- 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...
- Emkay Global maintains ‘buy’ on Ipca Labs, target price Rs 1,200The brokerage action came after the classification of Ipca's Silvassa plant as Official Action Indicated (OAI) by the US FDA after inspecti...
- Lupin's Goa facility may face regulatory action, says USFDAThe USFDA has stated that it may withhold approval of any pending applications or supplements in which this facility is listed," it added.
- USFDA recommends action against Strides Pharma Science Puducherry unitThe company believes that the classification will not have an impact on the current supplies and revenues from the facility," Strides Pharm...
- Sell Lupin, target Rs 800: Elara CapitalSell Lupin at a price target of Rs 800.
- USFDA retains OAI status for Indoco's Goa plantThe facility was inspected by the USFDA in January 2019.
- Dr Reddy's gets EIR from USFDA for Srikakulam plantDr Reddy's today said it has received the establishment inspection report (EIR) from the USFDA for its its formulations facility in Srikaku...
- Japan’s ORIX sees an OAIS in car rental spaceWith $25 million additional funding, company aims to achieve 10% market share in a year.
- Cabsguru partners with ORIX, to launch premium services from 8 citiesCabsguru, a meta-search engine for road travel, has signed a deal with ORIX Auto Infrastructure Services Limited (OAIS) to launch a premium...
- 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.
- Delhi gets new cab serviceOrix Auto Infrastructure Services Limited (OAIS) today launched a new cab service for the city with a fleet comprising 100 cars.
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