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Alembic Pharma up 8% as USFDA approves Doxycycline Hyclate capsules

The stock has moved higher by 8% to Rs 530, bouncing back 11% from early morning low of Rs 478 on the BSE.

SI Reporter  |  Mumbai 

According to UNAIDS, India has 2.1 million people living with HIV

has moved higher by 8% to Rs 530, bouncing back 11% from early morning low on the BSE after the company announced that it has received US drug regulator’s approval USP, 50 mg and 100 mg. The stock hit an intra-day low of Rs 478 in early morning trade.

“The company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for 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

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, 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.

First Published: Thu, June 14 2018. 11:24 IST