At 09:44 am; Nifty Pharma index, the largest gainer among sectoral indices, was up 1.4% at 10,086 points, as compared to 0.14% rise in the Nifty 50 index. The index hit a 52-week high of 10,142, rising 2%, in early morning deal. It surpassed its previous high of 10,063 recorded on November 3, 2017 in intra-day trade.
Lupin, Cipla, Cadila Healthcare, Dr Reddy’s Laboratories, Aurobindo Pharma, Divi’s Laboratories, Sun Pharmaceutical Industries from the index were up in the range of 1% to 5% on the NSE. Of these Sun Pharma, Divi’s Laboratories and Cipla have hit their respective 52-week highs in intra-day trade.
Strides Pharma Science has rallied 5% to Rs 491 after the company on Wednesday said its step-down, wholly-owned subsidiary has received acceptance from the US health regulator for two key abbreviated new drug applications (ANDAs).
“Strides Pharma Global Pte. Ltd, Singapore, received ANDA ‘acceptable for filing’ correspondence from the US Food and Drug Administration (USFDA) for two key ANDAs that met the prioritisation factors as a potential first generic,” Strides Pharma Science said in a regulatory filing.
The company said the two products could be eligible for a potential 180-day exclusivity deal. As per IQVIA MAT data, the US market for these products cumulatively is $550 million.
Lupin was up 3% at Rs 916 after the company announced that it has received tentative approval for its Nudovra (Estradiol Valerate Tablets, 3 mg and 1 mg and Estradiol Valerate and Dienogest Tablets, 2 mg/2 mg and 2 mg/3 mg) Tablets from the US FDA to market a generic version of Bayer HealthCare Pharmaceuticals Inc.'s Natazia Tablets.
Nudovra is an estrogen/progestin combined oral contraceptive to be used by women to prevent pregnancy. The tablet reported annual sales of nearly 31.4 million US$ in the US market, as per IQVIA MAT June 2018 data.
Lupin in separate filing announced the launch of its Clobetasol Propionate Cream USP 0.05%, having received an approval from the US FDA earlier.
Clobetasol Propionate Cream USP 0.05% is the generic equivalent of Fougera Pharmaceuticals Inc.'s Temovate Cream, 0.05%. It is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses,the compay said.
Clobetasol Propionate Cream had annual sales of approximately US$ 108.6 million in the US, as per IQVIA MAT June 2018 data.