Lupin rose 0.73% to Rs 990.65 at 9:18 IST on BSE after the company said it has received final approval from USFDA to market a generic version of Aqua Pharmaceuticals Monodox Capsules in the United States.
The announcement was made after market hours on Thursday, 6 March 2014.
Meanwhile, the S&P BSE Sensex was up 93.23 points or 0.43% at 21,607.10.
On BSE, so far 1,458 shares were traded in the counter as against average daily volume of 75,000 shares in the past two weeks.
The stock hit a high of Rs 992.65 and a low of Rs 980 so far during the day.
Lupin said it has received final approval for its Doxycycline Capsules USP, 50 mg, 75 mg, and 100 mg from the United States Food and Drug Administration (FDA) to market a generic version of Aqua Pharmaceuticals Monodox Capsules 50 mg, 75 mg, and 100 mg. Lupin's Doxycycline Capsules 50mg, 75mg and 100mg are the AB-rated generic equivalents of Aqua Pharmaceuticals, LLC's Monodox Capsules 50mg, 75mg and 100mg and are indicated in the treatment of infections caused by various microorganisms and as an adjunctive therapy in severe acne.
The company also received final approval from the FDA for its Ciprofloxacin for Oral Suspension, 5 g/100 mL (250 mg/5 mL) and 10 g/100 mL (500 mg/5 mL) to market a generic version of Bayer HealthCare Pharmaceuticals, Inc.'s (Bayer) Cipro for Oral Suspension 5 g/100 mL and 10 g/100 mL, Lupin said. Lupin's Ciprofloxacin Oral Suspension, 5 g/100 mL (250 mg/5 mL) and 10 g/100 mL (500 mg/5 mL) is the generic equivalent of Bayer's Cipro Oral Suspension 5 g/100 mL (250 mg/5 mL) and 10 g/100 mL (500 mg/5 mL) and indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in various conditions and patient populations.
Lupin is the first applicant to file an ANDA for Cipro Oral Suspension 250 mg/ml & 500 mg/ml and as such is entitled to 180 days of marketing exclusivity. Lupin Pharmaceuticals Inc. (LPI), the company's US subsidiary would commence marketing the products shortly, Lupin said in a statement.
Monodox Capsules had annual US sales of $180.6 million (IMS MAT Dec, 2013) whereas Cipro Oral Suspension had annual US sales of $8.6 million (IMS MAT Dec, 2013).
Lupin's consolidated net profit surged 42% to Rs 476.13 crore on 21% growth in net sales to Rs 2982.97 crore in Q3 December 2013 over Q3 December 2012.
Lupin is a pharmaceutical company producing and developing a wide range of branded and generic formulations and APIs globally. The company is a significant player in the cardiovascular, diabetology, asthma, pediatric, CNS, GI, anti-Infective and NSAID space and holds global leadership positions in the Anti-TB and cephalosporin segment.
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