Marksans Pharma receives final USFDA approval for generic famotidine tablets

Mumbai-based Marksans Pharma has received the final approval from the US Food and Drug Administration (FDA) for its generic version of Famotidine Tablets. The drug is used for the short-term treatment of gastroesophageal reflux disease (GERD) and for the treatment of active duodenal ulcer.

The approval from the FDA is for Famotidine Tablets USP, 20 mg and 40 mg, the generic version of Pepcid AC, which is marketed by Johnson & Johnson’s McNeil Consumer Healthcare Division.

According to the company, Famotidine Tablets have an estimated market size of $122 million in the US for the 12 months ending December 2021, based on IQVIA data.

Marksans Pharma is currently in discussions with potential partners for commercialisation of the product, which will be manufactured at the company’s Goa facility.

Commenting on the development, the Managing Director of Marksans Pharma, Mark Saldanha, said, “We are pleased to receive the final approval for Famotidine Tablets from the US FDA. This is an important milestone for our company and we look forward to bringing this product to market.”

Marksans Pharma has a portfolio of over 150 generic products in the US, and this approval will add to its growing product range.

The company has been expanding its global footprint with a focus on key markets such as the US and Europe. It has recently set up a new manufacturing plant in Poland, which will cater to the European market.

With this latest approval, Marksans Pharma is set to strengthen its position in the US market, which is the largest market for pharmaceutical products in the world.