Hot Pursuit     10-Jun-23
Zydus Life bags USFDA nod for Balsalazide Disodium capsules
Zydus Lifesciences announced that it has received final approval from the United States Food and Drug Administration (USFDA) for Balsalazide Disodium capsules.
The said drug is equivalent to reference listed drug, Colazal capsules. Balsalazide Disodium is used to treat bowel diseases like ulcerative colitis. It helps reduce symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and stomach pain. Balsalazide belongs to a class of drugs known as aminosalicylates and works by reducing swelling in the colon.

The drug will be manufactured at the group's formulation manufacturing facility in SEZ, Ahmedabad (India).

According to IQVIA MAT April 2023, Balsalazide Disodium Capsules USP, 750 mg had annual sales of $29 million in the United States.

The group now has 372 approvals and has so far filed over 442 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company's consolidated net profit (from continuing operations) tumbled 27.55% to Rs 298.8 crore despite of 31.66% jump in total revenue from operations to Rs 5,010.6 crore in Q4 FY23 over Q4 FY22.

The scrip slipped 1.15% to end at Rs 507.15 on Friday, 9 June 2023.

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