Hot Pursuit     03-Feb-25
Lupin's Somerset -based facility completes US FDA inspection with zero Form 483 observations
Lupin has announced that the the United States Food and Drug Administration (US FDA) has concluded the pre-approval inspection of the company’s Edaravone Oral Suspension, located at its manufacturing facility in Somerset, New Jersey.

The inspection was carried out from 28 January 2025 to 01 February 2025, and has concluded with zero 483 observations.

Nilesh Gupta, managing director, Lupin, said: "The successful outcome of the U.S. FDA inspection at our Somerset facility is a testament to our commitment to uphold and maintain the highest standards of quality, compliance and safety across our facilities. We remain steadfast in our mission to improve the lives of our patients globally.”

Mumbai-based Lupin is an innovation-led transnational pharmaceutical company. It develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The company's consolidated net profit jumped 74.1% to Rs 852.63 crore on 11.3% increase in sales to Rs 5,497.01 crore in Q2 FY25 over Q2 FY24.

The scrip fell 1.61% to currently trade at Rs 2022.05 on the BSE.

Previous News
  Lupin launches Ipratropium Bromide Nasal Solution in US market
 ( Corporate News - 04-Jul-25   16:05 )
  Lupin launches generic version of anticholinergic medication Ipratropium bromide in United States
 ( Hot Pursuit - 04-Jul-25   15:29 )
  Lupin gets USFDA nod for Loteprednol Etabonate Ophthalmic Gel
 ( Hot Pursuit - 02-Jul-25   12:53 )
  Lupin carves-out its LupinLife Consumer Healthcare
 ( Corporate News - 01-Jul-25   18:39 )
  Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Gel
 ( Corporate News - 01-Jul-25   18:37 )
  Lupin update on transfer of its OTC biz to LUPINLIFE Consumer Healthcare
 ( Corporate News - 30-Jun-25   18:54 )
  Lupin launches Prucalopride tablets in U.S. market
 ( Hot Pursuit - 26-Jun-25   13:12 )
  Lupin launches Prucalopride Tablets in US market
 ( Corporate News - 26-Jun-25   13:05 )
  Lupin receives USFDA approval for generic Prucalopride tablets
 ( Hot Pursuit - 25-Jun-25   13:47 )
  Lupin receives USFDA approval for Prucalopride Tablets
 ( Corporate News - 25-Jun-25   13:29 )
  Lupin allots 20,653 equity shares under ESOP
 ( Corporate News - 24-Jun-25   19:04 )
Other Stories
  Rajshree Polypack bags Rs 3-cr supply order
  05-Jul-25   16:04
  Power and Instrumentation secures Rs 3-cr work order from Nyati Engineering & Construction
  05-Jul-25   15:06
  RVNL bags Rs 143 cr LoA from Southern Railway for traction system upgrade in Tamil Nadu
  05-Jul-25   13:27
  Dhanlaxmi Bank gross advances rises 17% YoY in Q1 FY26
  05-Jul-25   12:45
  Texmaco Rail secures Rs 36-cr wagon order from TCI
  05-Jul-25   12:12
  Hazoor Multi Projects bags Rs 913-cr solar order from Apollo Green Energy
  05-Jul-25   11:27
  BEML secures $6.23 million export orders
  05-Jul-25   11:04
  Shakti Pumps raises Rs 292.6 crore via QIP; PineBridge, LIC MF among top investors
  05-Jul-25   09:52
  Bank of Maharashtra’s total deposits climb 14% YoY to Rs 3.05 lakh crore in Q1
  04-Jul-25   17:35
  GPT Infraprojects bags supply contract from Bangladesh-based Standard Engineers
  04-Jul-25   16:01
Back Top