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Alembic Pharma jumps on getting EIR from USFDA for Panelav facility
15-Jun-18   11:29 Hrs IST
The announcement was made during trading hours today, 15 June 2018.

Meanwhile, the S&P BSE Sensex was up 43.67 points, or 0.12% to 35,643.49.

On the BSE, 43,000 shares were traded in the counter so far compared with average daily volumes of 28,000 shares in the past two weeks. The stock had hit a high of Rs 540 and a low of Rs 505.90 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 said it received establishment inspection report (EIR) from United States Food and Drug Administration (USFDA) for the inspection carried out by them at the company's formulation facility at Panelav during the period from 12 March 2018 to 20 March 2018.

The company's shares rose 3.32% to end at Rs 506.55 yesterday, 14 June 2018, after the firm announced during trading hours that day that it has received approval from 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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