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Lupin in focus after USFDA approval for generic

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Lupin announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) to market a generic version of Bayer HealthCare Pharmaceuticals Inc.'s Natazia tablets. Lupin's 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 is the generic versional Bayer HealthCare Pharmaceuticals Inc.'s Natazia tablets. It is an estrogen/progestin combined oral contraceptive (COC), indicated for use by women to prevent pregnancy. 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 had annual sales of approximately $31.40 million in the US (IQVIA MAT June 2018). The announcement was made on Wednesday, 22 August 2018.

 

Housing Development Finance Corporation (HDFC) said it entered into an agreement for acquiring 30.52 lakh shares, representing 25.01% share capital of Good Host Spaces Private Limited from Manipal Integrated Services Private Ltd. The cost of acquisition for this transaction is Rs 69.50 crore. Good Host Spaces is engaged in the business of managing and operating student housing facilities and related services. The announcement was made after market hours on Tuesday, 21 August 2018.

IT major Infosys said it inaugurated its technology and innovation hub in Raleigh, North Carolina. In addition, Infosys announced that it has hired more than 4,700 Americans since Spring 2017, including nearly 500 in North Carolina, as part of the company's campaign to hire 10,000 American and accelerate the pace of innovation for American industry. The North Carolina Hub, located at 7751 Brier Creek Parkway in Raleigh, will help Infosys work more closely with clients in the region to develop cross-functional solutions to pressing business challenges in such areas as machine learning, artificial intelligence, user experience and advanced digital technologies, including big data and cloud. The Hub will also train, upskill and reskill Infosys and client employees in the technologies required to help American businesses accelerate their digital transformations. The announcement was made on Wednesday, 22 August 2018.

Strides Pharma Science announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore, received abbreviated new drug application (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 with a 10-month GDUFA II review goal date. As per IQVIA MAT data, the US market for these products cumulatively is $550 million. The USFDA also granted Strides' request to designate the drug product under these ANDAs as a Competitive Generic Therapy (CGT). If Strides is the first approved applicant with such competitive generic therapies, these products could be eligible for a potential 180-day CGT exclusivity, which functions in a similar manner to the Patent Challenge exclusivity for ANDAs. The announcement was made on Wednesday, 22 August 2018.

Ultratech Cement said it received Competition Commission of India's approval for the acquisition of cement business of Century Textiles and Industries with self. The company says that copy of the Competition Commission of India (CCI) order is awaited. The announcement was made after market hours on Tuesday, 21 August 2018.

Bharat Petroleum Corporation (BPCL) will be watched. With reference to news item titled, "BPCL likely to keep Mumbai refinery shut for 2 months", BPCL clarified after market hours on Tuesday, 21 August 2018, that the media report is factually incorrect. Only, Hydrocracker unit is shutdown and period of shutdown is currently being assessed. All other units are operating normal.

Nestle India announced that it will partner with Flipkart to launch MAGGI Special Masala Noodles. As a part of the partnership, from August 21 consumers can pre-book MAGGI Special Masala Noodles on Flipkart, this product will also be available exclusively on Flipkart from August 25 - 30, following which it will be available nationwide through Nestle's strong distribution reach. The announcement was made after market hours on Tuesday, 21 August 2018.

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First Published: Aug 23 2018 | 8:11 AM IST

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