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Alembic Pharma bags USFDA nod on erlotinib tablets

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The drug maker received a final approval from the US drug regulator for its Abbreviated New Drug Application (ANDA) for erlotinib tablets, 25 mg, 100 mg and 150 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tarceva tablets, 25 mg, 100 mg and 150 mg, of OSI Pharmaceuticals.

The drug is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen.

Erlotinib tablet in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

As per IQVIA data, Erlotinib tablets, 25 mg, 100 mg and 150 mg, have an estimated market size of $37 million for twelve months ending March 2021.

Meanwhile, Alembic Pharmaceuticals has a cumulative total of 148 ANDA approvals (130 final approvals and 18 tentative approvals) from USFDA. The announcement was made during market hours today, 9 July 2021.

On a consolidated basis, Alembic Pharmaceuticals' net profit jumped 16.7% to Rs 237.41 crore on 6.1% increase in net sales to Rs 1,280.39 crore in Q4 FY21 over Q4 FY20.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.

Shares of Alembic Pharmaceuticals rose 0.10% to Rs 985.90 on BSE. The stock traded in the range of Rs 981.65 to Rs 993.65 so far.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

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First Published: Fri, July 09 2021. 11:23 IST