Zydus Lifesciences Ltd, an indigenous pharmaceutical company, announced on Monday that it has obtained the final approval from the United States Food and Drug Administration (USFDA) to produce and sell Azithromycin tablets.
Azithromycin is a drug that is used to treat various bacterial infections such as bronchitis, pneumonia, sexually transmitted diseases, infections of the ears, lungs, sinuses, skin, throat, and reproductive organs, according to the company's filing with the stock exchange. The drug will be manufactured at the company's formulation manufacturing facility in Moraiya, Ahmedabad.
In the third quarter ending on December 31, 2022, the company posted a 24.48 percent increase in consolidated net profit to Rs 622.9 crore. The company had a consolidated net profit of Rs 500.4 crore in the same period last fiscal year. The consolidated total revenue from operations for the period was Rs 4,362.3 crore, up from Rs 3,639.8 crore in the previous year. However, total expenses in the third quarter increased to Rs 3,620.7 crore from Rs 3,096.3 crore in the corresponding period last fiscal year.
Zydus Lifesciences revealed that Azithromycin tablets USP, 500 mg, had US annual sales of $20 million. The group has received 360 approvals and filed over 440 ANDAs (Abbreviated New Drug Applications) since the commencement of the filing process in FY04, as of December 31, 2022.