Sun Pharmaceutical Industries rose 1.42% to Rs 623.45 at 9:21 IST on BSE after the company said that its subsidiary secured final approval from USFDA to market a generic version of Temodar, Temozolomide Capsules in the United States.
The announcement was made after market hours on Thursday, 13 February 2014.
Meanwhile, the S&P BSE Sensex was up 61.28 points or 0.3% at 20,254.63.
On BSE, so far 33,000 shares were traded in the counter as against average daily volume of 1.49 lakh shares in the past two weeks.
The stock hit a high of Rs 626.25 and a low of Rs 619.10 so far during the day.
Sun Pharmaceutical Industries (Sun Pharma) announced that the USFDA has granted its subsidiary final approval for its abbreviated new drug application (ANDA) to market a generic version of Temodar, Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg.
Temozolomide Capsules, 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg are therapeutic equivalents of Merck Sharp & Dohme Corporation's Temodar Capsules. These Capsules have annual sales of approximately $400 million in the United States, Sun Pharma said in a statement.
Temozolomide Capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment and for adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine, Sun Pharma said.
Sun Pharma's consolidated net profit surged 73.73% to Rs 1531.09 crore on 51.59% increase in total income to Rs 4446.82 crore in Q3 December 2013 over Q3 December 2012. Sun Pharmaceutical Industries declared the Q3 result at the fag end of market hours on Thursday, 13 February 2014.
Sun Pharmaceutical Industries' branded generic sales in India rose 20% to Rs 947 crore in Q3 December 2013 over Q3 December 2012. US finished dosage sales rose 57% to $434 million (in $ terms) in Q3 December 2013 over Q3 December 2012. International formulation sales outside US rose 16% to $84 million (in $ terms) in Q3 December 2013 over Q3 December 2013. Overall international revenues accounted for more than 75% of total revenues in Q3 December 2013.
Earnings before interest, taxation, depreciation and amortization (EBITDA) rose 57% to Rs 1975 crore in Q3 December 2013 over Q3 December 2012. EBITDA margin stood at 46% in Q3 December 2013 compared to 44% in Q3 December 2012.
The Active Pharmaceutical Ingredients (API) business has strategic importance for vertical integration on key products. A cumulative of 252 DMF / CEP applications have been made, with 172 approved so far. External sales of API fell 17% to Rs 174 crore in Q3 December 2013 over Q3 December 2012. The decline is mainly due to increased captive consumption of APIs, Sun Pharmaceutical Industries said.
Consolidated Research and development (R&D) expense stood at Rs 306 crore, or 7.1% of sales in Q3 December 2013.
In Q3 December 2013, Abbreviated New Drug Application (ANDA) for 5 products were filed. After counting these, and adjusting for filings that were dropped, cumulatively ANDAs for 468 products have been filed with the US Food and Drug Administration (USFDA) (as on 31 December 2013). ANDAs for 4 products received approvals in the third quarter, taking the total number of approvals to 337 (as on 31December 2013). ANDAs for 131 products now await USFDA approval, including 14 tentative approvals. The total number of patent applications submitted now stands at 534 with 342 patents granted so far, Sun Pharmaceutical Industries said.
Sun Pharmaceutical Industries revised upwards its consolidated revenue growth guidance to 29% for the year ending 31 March 2014 compared to previous guidance of 25%. The revised guidance takes in to account the performance achieved in nine months ended December 2013, higher base of Q4 March 2013 on consolidation of acquisitions as well the risks associated with increase in competition for some products. Guidance is at constant exchange rate, the company said.
Sun Pharmaceutical Industries is an international specialty pharmaceutical company with over 72% sales from global markets. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in US, India and several other markets across the world.
Powered by Capital Market - Live News
