Alembic Pharma gets USFDA nod for Doxycycline Hyclate tablets

Alembic Pharmaceuticals Limited has received final approval from US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Doxycycline Hyclate Tablets USP, 20 mg.

The approved ANDA is therapeutically equivalent to Reference Listed Drug (RLD) product (RLD) Periostat Tablets, 20 mg of Galderma Laboratories, LP (Galderma).

Doxycycline Hyclate Tablets are indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis. As per IQVIA data, for the twelve-month ending December 2019, Doxycycline Hyclate Tablets USP, 20 mg have an estimated market size of US$ 7 million.

Adult periodontitis, one of the major causes of tooth loss in adults, is a chronic, non-painful, inflammatory disease of the supporting tissues of the teeth. Recent studies now support a role for adult periodontitis in contributing to more serious conditions than tooth loss, such as cardiovascular disease, pre-term labour and low-birth-weight babies.

Alembic has a cumulative total of 119 ANDA approvals (107 final approvals and 12 tentative approvals) from USFDA.

Looking at the recently concluded quarter Q3FY20, the consolidated revenue came in at Rs 1,209.13 crore, registering 18.8 per cent YoY increase. EBITDA for the quarter grew by 34.2 per cent YoY to Rs 325.05 crore with a corresponding margin expansion of 309 bps. PAT for the quarter came in at Rs 227.68 crore, with YoY increase of 33.3 per cent.

On Thursday, the stock of Alembic Pharma opened at Rs 650. In the early morning session, it dipped by 2.8 per cent to Rs 631.50 from its previous close of Rs 650.20.