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USFDA ISSUES
Stocks in news: Waaree Energies, Kotak Bank, HDFC Bank, Strides Pharma, Persistent SystemsIndian markets showed volatility, ending nearly flat despite positive signals. Analysts note Nifty faces resistance from key moving average...- USFDA concludes inspection at Jubilant HollisterStier's Spokane plant with 8 observationsJubilant Pharmova announced its US subsidiary, Jubilant HollisterStier LLC, underwent a USFDA inspection. The facility in Spokane, Washingt...
- Sun Pharma: How a small Kolkata trader became a global buyout artistSun Pharma, led by Dilip Shanghvi, is poised for its largest overseas acquisition, a $12.5 billion deal for Organon & Co. This move continu...
- Cipla gets USFDA nod for generic respiratory issues treatment inhalation aerosolPharma major Cipla has secured final approval from the US health regulator for its generic albuterol sulfate inhalation aerosol. This marks...
- USFDA issues Form-483 with 5 observations to Ajanta Pharma's Paithan facilityAjanta Pharma said the US FDA has issued Form-483 with five observations after inspecting its Paithan manufacturing facility in Maharashtra...
- Stocks in news: HDFC Bank, ICICI Bank, RIL, Trent, Jio FinancialIndian markets are set for a dynamic start today. Investors will closely watch the Q4 results from banking giants HDFC Bank and ICICI Bank....
- USFDA issues Form 483 with 3 observations to Ipca's Tarapur plantAs per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any con...
- Sun Pharma gets eight observations from USFDA for Halol plantSun Pharma announced that the USFDA issued a Form 483 with eight observations after inspecting its Halol manufacturing plant in Gujarat. Th...
- USFDA issues Form 483 with 11 observations to Raleigh plant of Aurobindo Pharma armAurobindo Pharma Ltd announced that the USFDA issued a Form 483 with 11 observations following an inspection of its Aurolife Pharma LLC's R...
- USFDA issues Form 483 with five observations to Torrent Pharma unitTorrent Pharmaceuticals announced that the US Food and Drug Administration (USFDA) issued a Form 483 with five observations after inspectin...
- Ipca Labs falls 3% after USFDA issues Form 483 to API unitShares of Indian pharmaceutical company, Ipca Laboratories, fell by 3% after the US Food and Drug Administration (USFDA) issued a Form 483 ...
- USFDA issues CRL for Bevacizumab license application moved by Viatris: Biocon"The USFDA has issued a CRL for the Biologics License Application (BLA) for Bevacizumab filed by our partner Viatris (Mylan)," a company sp...
- USFDA issues 3 observations on Zydus' Jarod manufacturing unit"We are confident of addressing and resolving the issues to the satisfaction of USFDA. We remain committed to building a quality culture ac...
- Alembic Pharma receives 4 observations from USFDA for Panelav facility"The US Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals general oral solid formulation facility...
- USFDA issues response letter for new drug application for insulin glargine: BioconBiocon is confident of addressing these observations through a corrective and preventive action plan in a timely manner, it added.
- Biocon tumbles 9% as USFDA issues 10 observationsThe FDA inspection took place on May 25, June 1 and June 3.
- USFDA made 9 observations post Halol unit inspection: Sun PharmaThe United States Food and Drug Administration (USFDA) inspected the Halol facility from November 17, 2016 through December 1, 2016, Sun Ph...
- Most pharma companies earn USFDA wrath over data integrity issuesThe US is the largest market for domestic generic companies, contributing 25-55% of revenues for large companies, while India supplies arou...
- BofA Merrill Lynch cuts Aurobindo price target; retains buyBank of America Merrill Lynch has retained its buy rating on Aurobindo Pharma, while lowering its price target to Rs 125.
- USFDA issues warning to RanbaxyThe USFDA has issued a warning letter to domestic pharma major Ranbaxy for deviations from good manufacturing practices at its Paonta Sahib...
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