Alembic Pharma spurts after USFDA nod for Doxycycline Hyclate capsules

Alembic Pharmaceuticals rose 7.09% to Rs 525 at 11:03 IST on BSE after the company said it received US drug regulator's approval for Doxycycline Hyclate capsules.

The announcement was made during trading hours today, 14 June 2018.

Meanwhile, the S&P BSE Sensex was down 197.41 points, or 0.55% to 35,541.75.

On the BSE, 34,000 shares were traded in the counter so far compared with average daily volumes of 20,000 shares in the past two weeks. The stock had hit a high of Rs 529.90 and a low of Rs 478.05 so far during the day. The stock hit a 52-week high of Rs 588 on 15 February 2018. The stock hit a 52-week low of Rs 412.40 on 24 May 2018.

Alembic Pharmaceuticals announced that it 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. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Vibramycin capsules, 50 mg and 100 mg, of Pfizer Inc.

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.

Doxycycline Hyclate capsules USP, 50 mg and 100 mg, have an estimated market size of $80 million for twelve months ending December 2017 according to IQVIA. Alembic now has a total of 73 ANDA approvals (65 final approvals and 8 tentative approvals) from USFDA.

On a consolidated basis, net profit of Alembic Pharmaceuticals rose 0.81% to Rs 93.79 crore on 15.10% rise in net sales to Rs 853.31 crore in Q4 March 2018 over Q4 March 2017.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company.

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