Lupin gets USFDA tentative approval for tablets improving glycaemic control

Lupin Limited has received tentative approval for its Empagliflozin & Metformin Hydrochloride extended-release (ER) tablets, 5 mg/1,000 mg, 10 mg/1,000 mg, 12.5 mg/1,000 mg, and 25 mg/1,000 mg, from United States Food & Drug Administration (USFDA). The product will be manufactured at Lupin's Nagpur facility in India. 

It is a generic equivalent of Synjardy XR tablets, 5 mg/1,000 mg, 10 mg/1,000 mg, 12.5 mg/1,000 mg, and 25 mg/1,000 mg of Boehringer Ingelheim Pharmaceuticals, Inc. 

The tablets are indicated as a supplement with diet and exercise, to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both Empagliflozin and Metformin hydrochloride is appropriate. 

As per IQVIA MAT’s data of November 2020, Empagliflozin & Metformin Hydrochloride ER tablets had estimated annual sales of USD 357 million in the US. 

The company’s business in the September quarter delivered strong recovery, led by sequential growth across all geographies, in particular, US and India. The quarter marked the start of monetisation of its complex generic pipeline with the launch of Etanercept biosimilar in Europe and generic Albuterol in the US. During the quarter, it received 4 ANDA approvals and filed another inhalation product in the US. 

On Thursday, the stock of Lupin surged 2.9 per cent, making an intraday high of Rs 1,029.35 from its previous close of Rs 1,000.60 on BSE. It got closed at Rs 1,022.05.