The company has received USFDA tentative approval for its ANDA Pirfenidone tablets.
Shilpa Medicare share price gained nearly 6 percent in the morning trade on February 3 after the pharma company received US Food and Drug Administration (USFDA) approval for Pirfenidone tablets.
The company received USFDA’s tentative approval for its ANDA, Pirfenidone Tablets, 267 mg and 801 mg, on January 30. The ANDA is filed as 'First to File' submission on NCE -1 date.
Pirfenidone Tablets is a generic equivalent of reference listed drug (RLD) Esbriet Tablets of Hoffmann La Roche Inc used in the treatment of idiopathic pulmonary fibrosis.
The annual US market for Pirfenidone is approximately $716.3 Million, as per the IQVIA MAT Q2 2019 data.
The company received COSCO-New Delhi permission for manufacturing and marketing Lenvatinib capsules 4mg and 10mg in India, the first company to obtain generic approval for them in the country.
Also, the company receives approval for Lenvatinib mesylate capsules for patients of locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer and for the first-line treatment of patients with unresectable hepatocellular carcinoma in India.
At 0948 hours, Shilpa Medicare was quoting at Rs 306.00, up Rs 11.80, or 4.01 percent on the BSE.