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USFDA INSPECTION
Margin revival, Semaglutide launch to drive Dr Reddy’s growth momentum in FY27Dr Reddy's Laboratories anticipates a gradual recovery this fiscal year. The company faced a profit drop last year due to US business press...- Zydus Biologics’ Ahmedabad injectable facility gets 7 observations in USFDA inspectionZydus Lifesciences has made headlines as its Zydus Biologics injectable plant in Ahmedabad underwent a USFDA inspection between April 27 an...
- 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....
- Alkem Labs' Chakan facility gets six observations in USFDA inspection, no data integrity issuesAlkem Laboratories announced its subsidiary Enzene Biosciences received a Form 483 from the USFDA. The inspection at the Chakan manufacturi...
- Natco Pharma, 3 other pharma stocks decline up to 2.5% after important inspections at their units. Do you own?Indian pharmaceutical stocks, including Lupin, Shilpa Medicare, and Natco Pharma, are under scrutiny following recent USFDA inspections at ...
- 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...
- 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...
- Zydus Lifesciences gets 6 observations from USFDA for API plantThe US Food and Drug Administration (USFDA) conducted the inspection from December 14 to December 22, 2023. The inspection closed with six ...
- Dr Reddy's clears USFDA inspection for two plantsDr Reddy's said it has received establishment inspection report (EIR) for its formulations manufacturing unit in Srikakulam (FTO SEZ PU2), ...
- Lupin gets 2 observations from USFDA for Nagpur facility"The inspection closed with two 483 observations," Lupin said.
- Cipla announces closure of USFDA inspection at Bengaluru facilityThe company had earlier said that USFDA issued seven observations after conducting a routine 'CGMP inspection' at Cipla's API manufacturing...
- USFDA conducts inspection of Sun Pharma’s Halol site: SourcesThe USFDA inspection at Halol in 2015 had resulted in 23 observations – a set of deficiencies in the manufacturing processes.
- FDC sinks 8% as USFDA tightens screwsThe stock fell 7.74 per cent to hit a low of Rs 232.30 on the BSE today morning.
- 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...
- Strides Shasun R&D unit gets USFDA inspection closure reportUSFDA releases a copy of the EIR to the establishment that was the subject of an FDA or FDA-contracted inspection when the agency determine...
- Dishman Pharma gets EIRs for 3 sites from USFDA"Company's wholly owned subsidiary Carbogen Amcis AG, Switzerland has successfully completed United States Food and Drug Administration (US...
- Sharon receives EIR report from USFDA on inspection closureSharon Bio-Medicine said it has received the establishment inspection report (EIR) from the USFDA on closure of inspection of its Dehradun ...
- USFDA inspects Sharon Bio-Medicine's Dehradun-based plantLast month, USFDA had issued a warning letter to the firm for failing to pay generic drug user fee by its owner for three years starting 20...
- Shasun Pharmaceuticals shares surge over 7% on completion of regulatory inspectionShares of Shasun Pharmaceuticals surged in trade today after the company announced that it successfully completed the USFDA inspection.
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