Alembic Pharma inches up on receiving USFDA approvals

Alembic Pharmaceuticals announced that it received approval from US Food & Drug Administration (USFDA) for abbreviated new drug applications (ANDAs).

The company received final approval from the USFDA for Deferasirox tablets 90/360 mg (equivalent to Novartis Pharmaceuticals' Jadenu tablets). According to IQVIA, the drug had a market size of $415 million for 12-months ended December 2018.

The firm also received final approval for Deferasirox tablets for oral suspension 125/250/500 mg (equivalent to Novartis Pharmaceuticals' Exjade tablets). It had a market size of $135 million for 12-months ended December 2018.

Further, it received tentative approval for Deferasirox tablets 180 mg (equivalent to Novartis Pharmaceuticals' Jadenu tablets). It had a market size of $59 million for 12-months ended December 2018.

 

Deferasirox tablets are used in treatment of chronic iron overload to blood ending transfusions in patients 2 years of age and older.

Alembic now has a total of 107 ANDA approvals (95 final approvals and 12 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals were trading 0.96% higher at Rs 551.75 on BSE. The stock surged 10.27% in three months as compared to a 4.89% rise in Nifty Pharma index.

Meanwhile the NSE Nifty 50 index was trading 0.47% lower at 11,911.90.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company.

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