Glenmark Pharmaceuticals gets USFDA final approval for Tadalafil tablets

The global pharmaceutical company, Glenmark Pharmaceuticals announced on Thursday that it has received final approval for Tadalafil tablets USP along with tentative approval for Gabapentin Enacarbil extended-release tablets by United States Food & Drug Administration (USFDA). Additionally, the company has also received tentative approval for Apremilast tablets. 

Tadalafil tablets USP in the strengths of 2.5 mg, 5 mg, 10 mg & 20 mg is the generic version of Cialis of Eli Lilly & Company, which is used in the treatment of erectile dysfunction and enlarged prostate. Gabapentin Enacarbil extended-release tablets in the strengths of 300 mg & 600 mg is the generic equivalent of Horizant of Arbor Pharmaceuticals, LLC which is used to treat patients with moderate-to-severe primary restless legs syndrome (RLS). Meanwhile, Apremilast tablets in the strengths of 10 mg, 20 mg & 30 mg is a generic equivalent of Otezla of Amgen Inc and is used to treat certain types of psoriasis and psoriatic arthritis. 

According to IQVIA sales data for the 12-month period ending November 2020, Cialis, Horizant, and Otezla achieved annual sales of approximately USD 125.5 million, USD 99.5 million, and USD 2.7 billion, respectively.  

Glenmark is a research-led pharmaceutical company which has a product portfolio of 167 products authorised for distribution in the US marketplace as well as 44 abbreviated new drug applications (ANDAs) pending approval with USFDA. 

At 3.14 pm on Thursday, the stock of Glenmark was trading 1.05 per cent lower at Rs 493.50. The share has an intraday high of Rs 507.35 and an intraday low of Rs 492.50 on BSE.