The said drug is equivalent to reference listed drug, Arthrotec delayed release tablets.
Diclofenac belongs to nonsteroidal anti-inflammatory drug (NSAID) group of medicines. Diclofenac Sodium and Misoprostol Delayed Release Tablets are used to treat osteoarthritis and rheumatoid arthritis in people at high risk for developing stomach or intestinal ulcers.
The drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad (India).
According to IQVIA MAT March 2023, Diclofenac Sodium and Misoprostol delayed release tablets had annual sales of $13 million in the United States.
Further, the drug maker received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Varenicline tablets, a reference listed drug of Chantix tablets. Varenicline tablets are indicated to treat smoking addiction.
The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India and it will be launched shortly.
According to IQVIA MAT March 2023, Varenicline tablets had annual sales of $501 million in the United States.
The group now has 373 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.
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