Hot Pursuit     14-Apr-22
Alkem Laboratories Bioequivalence Center completes USFDA inspection with no observations
Alkem Loboratories on Thursday announced that its Bioequivalence Center located at Taloja, Maharashtra completed USFDA inspection without any observations.

The United States Food and Drug Administration (USFDA) commenced inspection from 11 April 2022 to 14 April 2022 at company's Bioequivalence Center situated in the state of Maharashtra and at the end of the inspection, no Form 483 was issued.

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Alkem Laboratories is a leading Indian pharmaceutical company with global operations, engaged in the development, manufacture and sale of pharmaceutical and nutraceutical products. The company produces branded generics, generic drugs, active pharmaceutical ingredients (APIs) and nutraceuticals, which it markets in India and International markets.

On a consolidated basis, the company reported a 15% rise in net profit to Rs 533.35 crore on a 13% increase in net sales to Rs 2,618 crore in Q3 FY22 over Q3 FY21.

Shares of Alkem Laboratories rose 0.59% to close at Rs 17.15 on BSE yesterday,13 April 2022.

Previous News
  Alkem Laboratories consolidated net profit rises 313.58% in the March 2024 quarter
 ( Results - Announcements 29-May-24   15:24 )
  Alkem's API unit at Ankleshwar clears USFDA inspection
 ( Corporate News - 08-Apr-23   11:35 )
  Alkem's St. Louis facility completes USFDA pre-approval inspection
 ( Corporate News - 10-Nov-22   17:30 )
  Alkem Lab PAT soars to Rs 294 cr in Q4
 ( Hot Pursuit - 29-May-24   15:45 )
  Alkem Laboratories Ltd drops for fifth straight session
 ( Hot Pursuit - 17-Aug-23   13:35 )
  Alkem Lab Indore plant gets USFDA observation
 ( Hot Pursuit - 08-Jul-22   09:18 )
  Alkem Laboratories Ltd soars 2.64%, Gains for third straight session
 ( Hot Pursuit - 08-Feb-23   13:05 )
  Alkem Laboratories enters into exclusive license agreement with Johns Hopkins University
 ( Corporate News - 31-Jan-22   20:58 )
  Alkem Lab to sell 8% stake in Enzene Biosciences
 ( Hot Pursuit - 26-Dec-22   10:13 )
  Alkem Laboratories fixes record date for final dividend
 ( Market Beat - Reports 13-May-22   18:06 )
  Alkem Laboratories Ltd soars 2.22%, up for third straight session
 ( Hot Pursuit - 02-Nov-22   13:05 )
Other Stories
  RVNL gains on emerging as L-1 bidder for Rs 133-cr railway project
  03-Jul-24   15:38
  Cholamandalam Financial Holdings Ltd leads losers in 'A' group
  03-Jul-24   15:00
  Sakuma Exports Ltd leads losers in 'B' group
  03-Jul-24   14:45
  NTPC power generation climbs 9.5% YoY in Q1
  03-Jul-24   14:41
  Volumes soar at MMTC Ltd counter
  03-Jul-24   14:30
  Oil and Gas shares fall
  03-Jul-24   14:00
  Real Estate stocks edge lower
  03-Jul-24   14:00
  Energy stocks edge lower
  03-Jul-24   14:00
  Sundaram-Clayton gains after board OKs to raise funds upto Rs 400 cr
  03-Jul-24   13:38
  JSW Infra's subsidiary concession agreement V.O. Chidambaranar Port Authority
  03-Jul-24   13:34
Back Top