Hot Pursuit     24-Feb-23
Alkem Lab gains as Indore facility gets EIR from USFDA
Alkem Laboratories rose 1.15% to Rs 3,313.75 after the company received Establishment Inspection Report (EIR) from the US drug regulator for its Indore facility, indicating closure of the inspection.
The company had earlier informed that the United States Food and Drug Administration (USFDA) had conducted good manufacturing plant (GMP) and pre-approval inspection at its Indore facility from 1 July 2022 to 7 July 2022 and issued Form 483 with 1 observation.

In response to Form 483 issued by the USFDA, the company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines. The inspection has now been closed by the US FDA.

Alkem Laboratories is engaged in pharmaceutical business with global operations. The company is engaged in the development, manufacture and sale of pharmaceutical and nutraceutical products.

The company's consolidated net profit declined 13.5% to Rs 454.71 crore despite of 16.1% rise in net sales to Rs 3,040.91 crore in Q3 FY23 over Q3 FY22.

Previous News
  Alkem Laboratories to declare Quarterly Result
 ( Corporate News - 25-Jul-24   16:59 )
  Alkem Laboratories to convene AGM
 ( Corporate News - 28-Jun-24   19:25 )
  Alkem Laboratories Ltd spurts 1.62%, rises for third straight session
 ( Hot Pursuit - 22-Dec-22   13:05 )
  Alkem Laboratories consolidated net profit declines 72.73% in the June 2022 quarter
 ( Results - Announcements 05-Aug-22   13:55 )
  Alkem Lab gains as Indore facility gets EIR from USFDA
 ( Hot Pursuit - 24-Feb-23   09:46 )
  Alkem Lab Mandva facility gets 3 USFDA observations
 ( Hot Pursuit - 02-Dec-23   11:08 )
  Volumes spurt at Alkem Laboratories Ltd counter
 ( Hot Pursuit - 26-Apr-24   11:00 )
  Alkem Laboratories fixes record date for interim dividend
 ( Market Beat - Reports 24-Jan-22   18:24 )
  Alkem Laboratories Ltd rises for third consecutive session
 ( Hot Pursuit - 13-Sep-23   13:05 )
  Alkem Laboratories
 ( Results - Analysis 04-Feb-22   15:40 )
  Board of Alkem Laboratories appoints director
 ( Corporate News - 05-Aug-22   14:02 )
Other Stories
  Avantel Q2 PAT jumps 42% YoY to Rs 23 cr
  05-Oct-24   17:03
  Equitas SFB total deposits jump 29% YoY in Q2 FY25
  05-Oct-24   16:28
  Ujjivan SFB total deposits rises 17% in Q2 FY25
  05-Oct-24   15:34
  L&T Finance retail disbursements jump 12% YoY in Q2 FY25
  05-Oct-24   14:31
  Bandhan Bank records over 21% YoY jump in loan book during Q2 FY25; deposits at Rs 1.42 lakh crore
  05-Oct-24   13:32
  Lupin's Pune-based biotech facility gets 5 observations from US FDA
  05-Oct-24   13:20
  Macrotech Developers pre-sales jumps 21% YoY in Q2 FY25
  05-Oct-24   09:04
  UCO Bank’s total advances jump 19% YoY in Q2 FY25
  04-Oct-24   15:15
  Vakrangee Ltd leads losers in 'A' group
  04-Oct-24   15:00
  Kamdhenu Ventures Ltd leads losers in 'B' group
  04-Oct-24   14:45
Back Top