Alembic Pharma gets USFDA nod for manufacturing Erlotinib tablets

Alembic Pharmaceuticals Limited, a leading pharmaceutical company, announced today that it has received a go-ahead from United States Food & Drug Administration (USFDA) for manufacturing Erlotinib tablets. This tablet is the company’s abbreviated new drug application (ANDA), which will be manufactured in three strengths i.e. 25 mg, 100 mg & 150 mg.  

Erlotinib tablet is therapeutically equivalent to Tarceva tablet, which is a reference listed drug product (RLD) of OSI Pharmaceuticals, LLC, a pharmaceutical company headquartered in New York, USA.   

It is used for treating 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.   

This condition is diagnosed and confirmed by FDA-approved test, after which, the patients receive first-line, maintenance, or second or greater line treatment after progression, following at least one prior chemotherapy regimen.  

Apart from this, Erlotinib tablet used in conjunction with Gemcitabine for the first-line treatment of patients with locally advanced, unresectable, or metastatic pancreatic cancer.  

As per the estimates of IQVIA, Erlotinib tablets (in strengths 25 mg, 100 mg & 150 mg) have an estimated market size of USD 37 million for a period of 1 year ending March 2021.  

At 11.52 am, the share price of Alembic Pharmaceuticals Limited was trading at Rs 977.60, which was a decrease of 0.69 per cent over its previous day’s closing price of Rs 984.95 on BSE.