Hot Pursuit     17-Mar-25
Lupin gains after getting tentative USFDA approval for Amifampridine tablets 10 mg
Lupin added 1.65% to Rs 1,993.60 after the pharma major announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its abbreviated new drug application (ANDA) for Amifampridine Tablets, 10 mg.

Amifampridine Tablets, 10 mg, are bioequivalent to Firdapse Tablets, 10 mg, from Catalyst Pharmaceuticals, Inc., and are indicated for the treatment of Lambert-Eaton Myasthenic Syndrome in adults and pediatric patients 6 years of age and older. This product will be manufactured at Lupin’s Goa facility in India.

Amifampridine Tablets, 10 mg (RLD Firdapse), had an estimated global net sale of $306 million for the fiscal year ended 31 December 2024.

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 US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Lupin’s consolidated net profit jumped 38.81% to Rs 858.86 crore on a 10.60% increase in sales to Rs 5,618.6 crore in Q3 FY25 compared to Q3 FY24.

Previous News
  Lupin rallies after receiving USFDA nod for Tolvaptan tablets
 ( Hot Pursuit - 24-Apr-25   11:40 )
  Lupin receives USFDA approval for Tolvaptan Tablets
 ( Corporate News - 24-Apr-25   11:06 )
  Lupin gets EIR from USFDA for Nagpur facility
 ( Hot Pursuit - 17-Apr-25   15:00 )
  Nanomi wins prestigious CMO Award for Life Science Leadership in Drug Delivery
 ( Corporate News - 21-Mar-25   19:12 )
  Lupin allots 24,101 equity shares under ESOP
 ( Corporate News - 21-Mar-25   16:10 )
  Lupin receives USFDA tentative approval for Amifampridine Tablets
 ( Corporate News - 17-Mar-25   13:36 )
  Lupin gains after getting tentative USFDA approval for Amifampridine tablets 10 mg
 ( Hot Pursuit - 17-Mar-25   10:44 )
  Lupin launches Rivaroxaban drug in US
 ( Hot Pursuit - 10-Mar-25   10:02 )
  Lupin launches Rivaroxaban Tablets USP, 2.5 mg in the US
 ( Corporate News - 07-Mar-25   16:43 )
  Lupin Ltd spurts 0.59%, up for five straight sessions
 ( Hot Pursuit - 06-Mar-25   13:00 )
  Lupin allots 59,940 equity shares under ESOP
 ( Corporate News - 27-Feb-25   12:40 )
Other Stories
  Aegis Logistics Ltd gains for third straight session
  29-Apr-25   13:05
  Go Digit General Insurance tumbles as Q4 PAT slides 2% QoQ to Rs 116 crore
  29-Apr-25   13:04
  IndusInd Bank Ltd spurts 0.75%, up for five straight sessions
  29-Apr-25   13:00
  Hexaware Tech jumps after Q1 PAT rises 3% QoQ to Rs 327 cr in CY25
  29-Apr-25   12:49
  Vimta Labs rises after strong Q4 performance; board OKs 1:1 bonus share issue
  29-Apr-25   12:49
  Tata Tech slides after large block deal
  29-Apr-25   12:38
  Nippon Life Q4 PAT slides 13% YoY to Rs 298 crore; declares dividend of Rs 10/sh
  29-Apr-25   12:26
  Firstsource Solutions Q4 PAT rises 20% YoY to Rs 161 cr in FY25
  29-Apr-25   12:26
  Growington Ventures India Ltd leads gainers in 'B' group
  29-Apr-25   12:15
  Hatsun Agro Product drops after Q4 PAT slide 18% YoY to Rs 43 cr
  29-Apr-25   12:04
Back Top