Shilpa Medicare has received United States Food and Drug Administration (USFDA)'s tentative approval for its abbreviated new drug application (ANDA), apremilast tablets, 10 mg, 20 mg, and 30 mg.
The ANDA was filed as 'First to File' submission on NCE -1 date to seek eligibility for 180 days exclusivity.
Apremilast tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene, used in the treatment of 'psoriatic arthritis' as recommended in the label approved by FDA.
According to IQVIA MAT Q2 2020 data, the US market for apremilast tablets, 10 mg, 20 mg, and 30 mg is approximately US $2.4 billion.
Shilpa Medicare is a global brand in manufacturing and supplying of affordable API and formulation globally in different regulated markets.
The company's consolidated net profit dropped 86.07% to Rs 7.67 crore on a 19.25% fall in net sales to Rs 191.25 crore in Q3 FY21 over Q3 FY20.
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