Cadila Healthcare gets final USFDA nod for tofacitinib tablets

The drug maker on Monday announced that it has received final approval from the US drug regulator to market tofacitinib extended-release tablets 11 mg and 22 mg in the United States.

Cadila said it was the first ANDA filer on tofacitinib extended-release tablets 22 mg and currently holds 180-day exclusivity on this strength.

According to IQVIA data, Tofacitinib extended-release tablets had annual sales of approximately $2,082 million in the United States for the year ending June 2021. The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.

The group now has 321 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

In a separate announcement, the drug company said it received the Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D the world's first Plasmid DNA Vaccine for COVID-19. ZyCoV-D is a three dose vaccine which will be administered first on day zero, day 28th and then on the 56th day. ZyCoV-D is a Plasmid DNA vaccine which when administered produces the spike protein of the SARS-CoV-2 virus and elicits an immune response mediated by the cellular and humoral arms of the human immune system, which play a vital role in protection from disease as well as viral clearance.

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures, and markets a broad range of healthcare therapies including small molecule drugs, biologic therapeutics, and vaccines.

On a consolidated basis, the drug major posted a 35.2% rise in net profit to Rs 635.50 crore on 14.4% rise in net sales to Rs 3,917.40 crore in Q1 FY22 over Q1 FY21.

Shares of Cadila Healthcare were up 3.03% at Rs 551.40 on BSE.

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