Hot Pursuit     10-May-24
Strides Pharma rises afte receiving US FDA nod for hyperphosphatemia treatment drug
Strides Pharma Science added 2.36% to Rs 851.10 after the company announced that Strides Pharma Global has received approval from the United States Food & Drug Administration (US FDA) for Sevelamer Carbonate Tablets.

Strides Pharma Global is a step down wholly owned subsidiary Strides Pharma Science.

The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Renvela Tablets of Genzyme.

Sevelamer Carbonate is a phosphate binder, that helps prevent hypocalcemia (low levels of calcium in the body) caused by elevated phosphorus.

Sevelamer Carbonate Tablets has a market size of approximately $181 million, as per IMS.

The Sevelamer tablets will be manufactured at the company’s facility in Puducherry.

“This approval further strengthens the company's presence in the Sevelamer portfolio, complementing the existing approval of Sevelamer Carbonate Powder for oral suspension, which has a market size of US$23 million,” Strides Pharma said in a statement.

The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which more than 245 ANDAs have been approved.

The company has set a target to launch nearly 60 new products over three years in the US.

Strides Pharma Science is engaged in develops and manufactures a wide range of IP-led niche pharmaceutical products.

The firm reported consolidated net profit of Rs 49.67 crore in Q3 FY24 as against a net loss of Rs 80.03 crore posted in Q3 FY23. The company recorded quarterly sales of Rs 1,038.9 crore in Q3 FY24, registering a growth of 19.60% from Rs 868.6 crore in Q3 FY23.

Previous News
  Strides Pharma Science to convene board meeting
 ( Corporate News - 14-May-24   14:28 )
  Strides Pharma rises afte receiving US FDA nod for hyperphosphatemia treatment drug
 ( Hot Pursuit - 10-May-24   13:03 )
  Strides Pharma Global receives USFDA approval for Sevelamer Carbonate Tablets, 800 mg
 ( Corporate News - 10-May-24   12:50 )
  Strides Pharma Science allots 10,000 equity shares under ESOP
 ( Corporate News - 29-Apr-24   13:23 )
  Strides Pharma Global receives USFDA approval for Fluoxetine Tabs
 ( Corporate News - 09-Apr-24   09:54 )
  Strides Pharma gets US FDA nod for antidepressant drug
 ( Hot Pursuit - 09-Apr-24   09:14 )
  Strides Pharma’s Chennai facility gets 2 observations
 ( Hot Pursuit - 08-Apr-24   09:47 )
  USFDA conducts audit of Stride Alathur's formulations unit
 ( Corporate News - 06-Apr-24   16:50 )
  Strides Pharma receives USFDA approval for Gabapentin Tablets
 ( Corporate News - 05-Mar-24   15:55 )
  Strides Pharma gains on USFDA nod for Gabapentin tablets
 ( Hot Pursuit - 05-Mar-24   14:02 )
  Strides Pharma gains on reporting turnaround Q3 numbers
 ( Hot Pursuit - 30-Jan-24   15:36 )
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