This pharma company trades higher after receiving final approval from US FDA for its new drug application

Shares of the company zoomed 8 per cent on getting the final nod for Ketorolac Tromethamine Injection.

Alembic Pharmaceuticals is currently trading at Rs 661.55, up by 49.35 points or 8.06 per cent from its previous closing of Rs 612.20 on the BSE. The scrip opened at Rs 608.70 and has touched a high and low of Rs 675.00 and Rs 603.55, respectively. The BSE group 'A' stock of face value of Rs 2 has touched a 52-week high of Rs 847.95 and a 52-week low of Rs 541.10. 

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ketorolac Tromethamine Injection USP, 15 mg/mL, 30 mg/mL, and 60 mg/2 mL (30 mg/mL) Single Dose Vials. This is the second injectable product approved by the company’s General Sterile Facility (F-3) which was inspected in August 2022. 

Ketorolac Tromethamine Injection USP has an estimated market size of $59 million for twelve months ending June 2022 according to IQVIA. The company has a cumulative total of 175 ANDA approvals (151 final approvals and 24 tentative approvals) from the USFDA. 

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Health care since 1907. Alembic Pharma operates through 3 primary business segments - International generics (52 per cent of sales, with 75 per cent being from the US), Domestic branded business (32 per cent of sales), and API business (16 per cent of sales). 

The company has high R&D allocation with new capabilities being developed across Injectable, Oncology, Dermatology, and Opthalmology in the last 5 years.     

The promoters holding in the company stood at 69.61 per cent, while Institutions and Non-Institutions held 17.87 per cent and 12.52 per cent respectively.