Unichem Lab gains after receiving USFDA approval for drug

Unichem Laboratories rose 2.51% to Rs 229 at 13:00 IST on BSE after the company received Abbreviated New Drug Application approval from USFDA for Quetiapine Fumarate Tablets.

The announcement was made during market hours today, 9 March 2016.

Meanwhile, the S&P BSE Sensex was down 51.53 points or 0.23% at 24,603.26.

On BSE, so far 5,392 shares were traded in the counter as against average daily volume of 15,357 shares in the past one quarter. The stock hit a high of Rs 229.50 and a low of Rs 220 so far during the day. The stock had hit a record high of Rs 334 on 6 October 2015. The stock had hit a 52-week low of Rs 174 on 8 June 2015. The stock had outperformed the market over the past one month till 8 March 2016, rising 3.55% compared with gains of 1.53% in the Sensex. The scrip had, however, underperformed the market in past one quarter, sliding 20.79% as against Sensex's 2.57% fall.

The mid-cap company has equity capital of Rs 18.16 crore. Face value per share is Rs 2.

Unichem Laboratories said that Quetiapine Fumarate Tablets, 25mg, 50mg, 100mg, 200mg, 300mg and 400mg are therapeutically equivalent to Seroquel Tablets, 25mg, 50mg, 100mg, 200mg, 300mg and 400mg of AstraZeneca Pharmaceuticals LP.

Quetiapine Fumarate is an atypical antipsychotic indicated for the treatment of Schizophrenia. Quetiapine Fumarate is also indicated for the acute treatment of manic episodes associated with bipolar I disorder. It is also indicated as a monotherapy for the acute treatment of depressive episodes associated with bipolar disorder.

The product will be commercialized from Unichem's Ghaziabad plant. Active pharmaceutical ingredient (API) will also be made in house at Pithampur API plant.

Unichem Laboratories' net profit spurted 897.1% to Rs 20.54 crore on 15.6% growth in net sales to Rs 303.93 crore in Q3 December 2015 over Q3 December 2014.

Unichem Laboratories is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and several other markets across the world. In India, the company is a leader in niche therapy areas of cardiology, neurology, orthopedics and anti-infectives. The company has strong skills in product development, process chemistry and manufacturing of complex APIs as well as dosage forms.

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