Alembic gets tentative nod from USFDA for anti-inflammatory drug

Vadodara-based Alembic Pharmaceuticals is all set to enter the $2 billion market of generic anti-inflammatory drug celecoxib as it received a tentative approval for marketing the drug from the US drug regulator.

While the company confirmed the development, it did not wish to comment on the matter saying it was a tentative nod. According to Sarabjit Kaur Nangra, vice president research, pharma, Angel Broking, "Alembic Pharmaceuticals got tentative approval from US Food and Drug Administration (USFDA) for its generic anti-inflammatory drug Celecoxib oral capsules 50 mg, 100mg, 200 mg, 400 mg. GD Searle LLC division of Pfizer Inc is the innovator of this drug."

She further added that companies like Teva, Mylan, Watson, Lupin and Apotex have been selling Celecoxib drug, which is one of Pfizer's billion dollar drugs and has a $ 2 billion size. "Though the drug is tentatively approved and already being sold by many competitors, we believe the drug can contribute to the overall sales, given the size of the company when approved," she said.

Analysts feel that Alembic has a robust pipeline for international launches and the revenue growth outlook for the company is around 18-20 per cent in the coming years.

The company has filed cumulatively 66 ANDAs and 70 DMFs with USFDA upto December 2015. It has an USFDA approved plant at Panelav in Gujarat with a capacity of 5 billion tablets and capsules per annum that is being expanded up to 7 billion tablets and capsules per annum.