Strides Pharma Science Limited Announcement

Bangalore: Strides Pharma Science Limited has announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for the generic version of Sucralfate Oral Suspension, 1gm/10 mL, from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Carafate 1gm/10mL of AbbVie.

Sucralfate is used to treat:

• Stomach ulcers
• Gastroesophageal reflux disease (GERD)
• Radiation proctitis
• Stomach inflammation
• To prevent stress ulcers

It is considered a cytoprotective agent, protecting cells in the gastrointestinal tract from damage caused by agents such as gastric acid, bile salts, alcohol, and acetylsalicylic acid (aspirin), among other substances.

Sucralfate Oral Suspension, 1gm/10 mL has a market size of approximately US$ 124 million as per IQVIA (March 2024). The Sucralfate Oral Suspension, 1gm/10 mL will be manufactured at the company’s flagship facility in KRS Gardens in Bangalore, India.

The company has 260 cumulative ANDA filings (including the acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which over 245 ANDAs have been approved. The company has set a target to launch approximately 60 new products over three years in the US.

Read also: Strides Pharma Science Singapore arm gets USFDA nod for Major Depressive Disorder drug Fluoxetine

Strides, a global pharmaceutical company headquartered in Bengaluru, India, is listed on the BSE Limited (532531) and National Stock Exchange of India Limited (STAR). The Company mainly operates in the regulated markets and has an “in Africa for Africa” strategy and an institutional business to service donor-funded markets. The Company’s global manufacturing sites are located in:

• India (Chennai, Puducherry, and two locations in Bengaluru)
• Italy (Milan)
• Kenya (Nairobi)
• The United States (New York)

The Company focuses on “difficult to manufacture” products sold in over 100 countries.

Read also: Strides Pharma Science arm gets USFDA nod for Hypocalcemia drug Sevelamer Carbonate