Alembic has a total of 115 ANDA approvals (103 final approvals and 12 tentative approvals) from USFDA.
The share price of Alembic Pharma gained more than 2 percent in the morning trade on January 28 after the company got the US drug regulator’s nod for Azithromycin tablets.
The company received the US Food & Drug Administration’s final approval for its abbreviated new drug application (ANDA) Azithromycin tablets USP, 600 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product Zithromax Tablets, 600 mg, of Pfizer Inc (Pfizer), the company said in a BSE filing.
Azithromycin is antibiotic used for treating bacterial infections.
Azithromycin Tablets USP, 600 mg had an estimated market size of $2 million for twelve months ending September 2019, according to IQVIA.
Alembic has a cumulative total of 115 ANDA approvals (103 final approvals and 12 tentative approvals) from USFDA.
Alembic Pharma reported 33.8 percent jump in its Q3FY20 net profit to Rs 227.31 crore against Rs 169.83 crore in December 2018. The company's net sales rose 18.7 percent at Rs 1,209.13 crore from Rs 1,018.15 crore, year-on-year (YoY).
The earnings before interest, tax, depreciation and amortisation (EBITDA) were up 32.4 percent at Rs 325.46 crore versus Rs 245.75 crore.
Brokerage firm Anand Rathi has a buy on the stock. It raised the target to Rs 740 from Rs 624, a return of 25 percent.
The long exclusivity in the US helped Alembic retain its growth momentum and launches (15-17 per annum) in the US. The stock is available at an attractive 14x FY22e PE, said Anand Rathi.The stock has gained 12 percent in the last 15 days and was quoting at Rs 628.95, up Rs 14.15, or 2.30 percent. It has touched an intraday high of Rs 630.00 and an intraday low of Rs 614.