Lupin drops as FDA raises concerns over Pithambur facility

Lupin fell 2.49% to Rs 1648.80 at 15:21 IST on BSE after the company said that US Food & Drug Administration inspected the company's Pithambur plant in January this year, after which it issued the company a Form 483, listing six observations.

The announcement was made during market hours today, 23 February 2015.

Meanwhile, the S&P BSE Sensex was down 279.51 points or 0.96% at 28,951.90.

On BSE, so far 1.29 lakh shares were traded in the counter as against average daily volume of 43,867 shares in the past one quarter.

The stock hit a high of Rs 1,703 and a low of Rs 1,604.40 so far during the day. The stock had hit a 52-week low of Rs 903.95 on 27 May 2014. The stock had hit a record high of Rs 1,705.60 on 19 February 2015.

The large-cap pharma company has equity capital of Rs 89.87 crore. Face value per share is Rs 2.

Lupin said that its two facilities, the Lupin Bioresearch Center, Pune (LBC) and a manufacturing facility at Pithambur, near Indore were audited by the United States Food & Drug Administration (USFDA) in November 2014 and January 2015 respectively. Both the audits were completed successfully with LBC not receiving any observations and the Indore facility receiving six observations (483's). Since then, the Indore facility has received 1 ANDA approval and 2 site-transfer approvals, Lupin said in a statement.

Meanwhile, Lupin announced today, 23 February 2015 that it has received final approval for its Bimatoprost Opthalmic Solution, 0.03% from USFDA to market a generic version of Allergan Inc.'s Lumigan Opthalmic Solution, 0.03%. Lupin Pharmaceuticals Inc. (LPI), the company's US subsidiary would commence marketing the product shortly, Lupin said in a statement.

Lupin's Bimatoprost Opthalmic Solution, 0.03% is the AT rated generic equivalent of Lumigan Opthalmic Solution, 0.03% and is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Lupin's Bimatoprost Opthalmic Solution, 0.03% filing was made from its Indore facility which was audited in January 2015.

Lupin's consolidated net profit rose 26.3% to Rs 601.45 crore on 5.4% growth in net sales to Rs 3144.91 crore in Q3 December 2014 over Q3 December 2013.

Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations as well as biotechnology product and APIs globally.

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