US FDA Approved Alembic Pharma’s Colon Cancer Injection


The US FDA approved Alaembic Pharma’s Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) in India. Patients with colon and rectal adenocarcinomas, breast adenocarcinomas, gastric adenocarcinomas, and pancreatic adenocarcinomas are treated with the injection.

Fluorouracil Infusion has an expected market size of $5 million for a considerable length of time finishing December 2022, as indicated by IQVIA. The US FDA has granted Alembic Pharma a total of 182 ANDA approvals, consisting of 159 final approvals and 23 tentative approvals.

The business announced last week that it would be taking an impairment charge of Rs 1,150.43 crore for its three manufacturing plants in Gujarat that are still under construction.

Due to COVID-19, the company said, the USFDA approval processes for these manufacturing facilities took longer than expected. Due to price erosion in the US generics market and rising global interest rates, it now fears that the cash generation estimates from these manufacturing facilities will have been significantly revised downward.

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The management conducted a review of the CWIP for these manufacturing facilities to determine the recoverable value in order to capitalize assets at their recoverable value.

In addition to the Rs 340 crore that have already been written off as a result of the purchase of Aleor Derma, Alembic Pharma’s partner stake, in March of this year, the impairment of Alembic Pharma goes beyond that. At the moment, the total amount of write-offs is Rs 1,490 crore.