“The company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxycycline Hyclate Capsules USP, 50 mg and 100 mg,” Alembic Pharma said in a press release.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Vibramycin Capsules, 50 mg and 100 mg, of Pfizer Inc, it added.
Alembic now has a total of 73 ANDA approvals (65 final approvals and 8 tentative approvals) from USFDA.
Doxycycline is indicated for a wide variety of bacterial infections including those caused by several gram-negative as well as gram-positive microorganisms. Doxycycline is also indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethaminesulfadoxine resistant strains. Doxycycline may be a useful adjunctive therapy in severe acne and in acute intestinal amebiasis, the company said.
According to IQVIA, Doxycycline Hyclate Capsules USP, 50 mg and 100 mg, have an estimated market size of US$ 80 million for twelve months ending December 2017.
At 11:20 am; the stock was trading 6% higher at Rs 519 on the BSE, as compared to 0.58% decline in the S&P BSE Sensex. The trading volumes on the counter more than doubled with a combined 578,519 shares changed hands on the BSE and NSE so far.