Alembic Pharma gains 7% on EIR from USFDA for formulation facility at Panelav

Alembic Pharmaceuticals share price rallied as much as 6.6 percent in morning trade on Friday after the company received clearance report for its Panelav facility in Gujarat.

The pharma company informed the exchange that it has received Establishment Inspection Report (EIR) from United States Food and Drug Administration (US FDA) after the inspection of Panelav plant.

The inspection by USFDA was carried out at formulation facility during the period from March 12 to March 20, 2018.

Meanwhile, its API facility also, which located at Panelav, had received zero observations after the scheduled inspection in April.

The USFDA had conducted an inspection at API Facility during April 16-23. This was a scheduled inspection.

On June 14, Alembic Pharmaceuticals has received approval from the 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 indlcated 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.

Alembic now has a total of 73 ANDA approvals (65 final approvals and 8 tentative approvals) from USFDA.

At 10:38 hours IST, the stock price was quoting at Rs 533.00, up Rs 26.45, or 5.22 percent on the BSE.