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USFDA CLASSIFICATION
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...
- 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...
- USFDA grants VAI classification to Dr Reddy's R&D centreDr Reddy's Laboratories announced that its Hyderabad-based R&D centre has received Voluntary Action Indicated (VAI) classification from the...
- Aurobindo Pharma's three units in Telangana gets VAI classification by USFDA, shares gainVAI means USFDA will not take regulatory action because the objectionable conditions if found are minor and may not qualify for enforcement...
- 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...
- Dr Reddy's gets USFDA inspection closure report for Srikakulam plantThe US Food and Drug Administration (USFDA) had issued a warning letter to the facility in November, 2015, after inspecting it in 2014.
- Alembic Pharma gets VAI classification from USFDA for its Panelav facilityAs per the USFDA, VAI classification means that though objectionable conditions or practices were found, the agency is not prepared to take...
- 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 says probe on Malaysia manufacturing unit ends“This is to inform you that Biocon Sdn Bhd, a subsidiary of Biocon, has received the EIR from the USFDA for the pre-approval inspection of ...
- Aurobindo Pharma gets EIR with VAI status from USFDA for Hyderabad facilityShares of Aurobindo Pharma were trading at Rs 508.50 a piece on BSE.
- 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...
- US health regulator finds Silvassa unit non-compliant with CGMP: Ipca LabsThe company said that since this manufacturing facility is already under USFDA import alert and presently not doing any US business, this w...
- USFDA for voluntary action by Cadila Healthcare on Ahmedabad SEZ facilityThe plant has received an establishment inspection report (EIR). The EIR report stated that the classification of the facility is VAI, it a...
- Jubilant Life's Nanjangud facility may face regulatory action by USFDAJubilant Life Sciences said USFDA's announcement will not have any impact on the existing revenues from operations of this facility.
- USFDA classifies Lupin's Somerset facility as 'Official Action Indicated''Official Action Indicated', means approvals of pending applications or supplements from this site maybe withheld.
- Have received inspection closure report from USFDA for Duvvada facility: Dr Reddy's"We have received a written communication about the issuance of establishment inspection report (EIR) for FTO VII", said Dr Reddy's.
- Dr Reddy's recalls 80,000+ bottles of Atorvastatin from USThe product is being recalled through three separate letters to the drug regulator. Dr Reddy's officials were not immediately available for...
- Dr Reddy's Laboratories recalls anti-seizure, hypertension drugs from US marketThe firm has started recalling Divalproex Sodium extended-release tablets as it has failed dissolution tests.
- Sun Pharma unit recalls mutiple lots of capsules from USCaraco Pharmaceutical Laboratories , a unit of Sun Pharma, has initiated a recall of multiple lots of Cephalexin capsules from the US marke...
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