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USFDA VAI 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...- Biocon shares surge 5% after USFDA classifies Bengaluru site as VAIBiocon Share Price: Biocon shares surged 5.4% after FDA classified its Bengaluru facility as Voluntary Action Indicated (VAI). The stock is...
- 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...
- 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...
- 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...
- Biocon gets establishment inspection report from USFDA for Bengaluru plantThe EIR has been closed with a voluntary action indicated (VAI) classification for the observations, it added. As per the USFDA, a VAI mean...
- 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...
- Aurobindo’s regulatory woes cast a shadow on strong fundamentalsIncidentally, the company has a sound business model with strong operating metrics and a high institutional holding of 34.6 per cent. Data ...
- 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.
- Aurobindo Pharma tumbles 18% on USFDA's U-turn; here's what analysts sayThe revocation of VAI seems almost like a warning letter, said Surjit Pal.
- Warning letter woes: Dr Reddy's expects FDA inspection of AP plant by year-endUSFDA had issued warning letter in November 2015 relating to Current Good Manufacturing Practice deviations at DR Reddy's API manufacturing...
- USFDA completes inspection of Strides Pharma Bengaluru plantThe company's facility in Bengaluru underwent a United States Food and Drug Administration (USFDA) inspection that ended on May 24, 2019, S...
- 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...
- 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.
- Shilpa Medicare climbs 7% on receiving EIR for Telangana unitThe facility was inspected between November 11 and November 30, 2017.
- 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.
- US FDA upgrades Jubilant Life's US plant statusThe company currently has 10 manufacturing facilities in India, the US and Canada with 6,200 as global headcount.
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