Corporate News     08-Sep-21
Caplin Steriles receives USFDA approval for Labetalol Hydrochloride Injection
Caplin Steriles, a subsidiary of Caplin Point Laboratories, has been granted final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Labetalol Hydrochloride Injection USP, 100 mg/20 mL (5 mg/mL) and 200 mg/40 mL (5 mg/mL) Multiple-dose Vials, a generic therapeutic equivalent version of (RLD), TRANDATE Injection, of Sebela Ireland.

Labetalol Hydrochloride Injection USP is indicated for control of blood pressure in severe hypertension. According to IQVIATM (IMS Health), Labetalol hydrochloride Injection had US sales data of approximately $6 million for the 12-month period ending June 2021.

Previous News
  Indices trade with major gains; pharma shares in demand
 ( Market Commentary - Mid-Session 07-Aug-24   14:33 )
  Caplin Point Laboratories to hold board meeting
 ( Corporate News - 30-Oct-25   10:51 )
  Caplin Point Laboratories Ltd leads gainers in 'A' group
 ( Hot Pursuit - 19-Aug-24   12:00 )
  Caplin Steriles receives USFDA approval for Milrinone Lactate in 5% Dextrose Injection infusion bags
 ( Corporate News - 03-Sep-25   16:20 )
  Caplin Point Labs subsidiary gets US FDA nod for schizophrenia treatment drug Haloperidol
 ( Hot Pursuit - 14-May-25   13:20 )
  Caplin Point Laboratories fixes record date for final dividend
 ( Market Beat - Reports 07-Aug-24   13:17 )
  Volumes soar at Hindustan Zinc Ltd counter
 ( Hot Pursuit - 19-Aug-24   11:00 )
  Caplin Point Laboratories consolidated net profit rises 16.27% in the December 2021 quarter
 ( Results - Announcements 03-Feb-22   14:02 )
  Caplin Point rallies after Q1 PAT climbs 20% YoY to Rs 125 cr
 ( Hot Pursuit - 07-Aug-24   13:23 )
  Volumes jump at Caplin Point Laboratories Ltd counter
 ( Hot Pursuit - 27-Feb-23   11:00 )
  Caplin Steriles receives USFDA approval for Phenylephrine hydrochloride Ophthalmic solution
 ( Corporate News - 24-May-24   12:26 )
Other Stories
  G R Infraprojects receives LoA for West Central Railway project of Rs 1897 cr
  17-Feb-26   20:21
  Dilip Buildcon bags Narmada river flood protection embankment project
  17-Feb-26   20:17
  GPT Infra - RVNL JV wins contract worth Rs 1,201 cr
  17-Feb-26   19:56
  Dilip Buildcon wins bid for Rs 702 cr flood protection embankment project
  17-Feb-26   19:50
  BHEL receives LoA from Steel Authority of India
  17-Feb-26   19:47
  Trident receives ESG rating of 69.5
  17-Feb-26   17:57
  Usha Martin receives ESG rating of 60
  17-Feb-26   17:54
  Board of Paras approves acquisition of 49% stake in Himanshi Thermal
  17-Feb-26   17:50
  Intellect partners with Adrenalin
  17-Feb-26   17:39
  Adani Group commits USD 100 billion to develop AI infrastructure ecosystem in India
  17-Feb-26   17:25
Back Top