Alembic Pharma gets USFDA nod for Doxycycline Hyclate tablets

On Wednesday, Alembic Pharma announced that it has received approval from United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Doxycycline Hyclate tablets USP, in dozes of 75 mg and 150 mg.

The drug is indicated for the treatment of certain Rickettsial, sexually transmitted, respiratory tract, bacterial and ophthalmic infections. It is also indicated for anthrax including inhalation anthrax. In addition, it is also used as an alternative treatment for certain infections where Penicillin is contraindicated. It is further used as adjunctive therapy for acute intestinal amebiasis and severe acne as well as for prophylaxis of malaria.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Acticlate tablets, 75 mg and 150 mg, of Almirall.

According to data from IMS Health and Quintiles (IQVIA), for twelve-month ended March 2020, Doxycycline Hyclate tablets USP, 75 mg and 150 mg have an estimated market size of US$ 17 million. The commercialisation of this product will positively impact the top-line of the companies in the quarters ahead.

Alembic Pharmaceuticals Ltd is a multinational pharmaceutical company headquartered in Vadodara (Gujarat). It is involved in the manufacture of pharmaceutical products, substances and intermediates. The company now has a total of 125 ANDA approvals (111 final approvals and 14 tentative approvals) from USFDA.

At 3 pm on Wednesday, the stock of Alembic Pharma was trading at Rs 905.25, down by 0.89 per cent or Rs 8.15 per share. The 52-week high is recorded at Rs 984 and the 52-week low is Rs 436.10 on BSE.