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Pharma shares remain in limelight on US FDA favorable inspection reports.


Date: 18-06-2018
Subject: Pharma shares remain in limelight on US FDA favorable inspection reports
The Indiain pharmaceutical companies shares remained in limelight during the last week ended June 15, 2018 on account of favorable inspection reports from US FDA, approvals and new launches. The BSE Hehalthcare index improved by 10 per cent to 14301.44 points from 13,002.72 points as at the end of May 2018, when all other indices were under pressure. The BSE Sensex improved only by 0.8 per cent to 35,622.14 from 35,322.38 during this period. Despite slower growth in top line and bottom line during 2017-18, pharma shares received strong support from investors and surged ahead. The BSE Healthcare index touched to lowest at 12,606.21 for the year 2018 on June 5, 2018 and then moved ahead strongly. 

The shares of pharma majors like Alembic Pharmaceuticals, Sun Pharmaceutical, Aarti Drugs, Dr Reddy's Laboratories, Lupin, Cipla, Granules, Ajanta Pharma, Aurobindo Pharma and Cadila Healthcare, moved up double digit during June so far. However, other majors like Biocon, Hester Bio, ERIS, Capline Point, Unichem Labs, Thyrocare, Jubilant Life Sciences,  Abbott India and Neuland Lab remained under pressure and declined.    

Sun Pharma share registered growth of 18.9 per cent and touched to Rs. 571.05 on June 15, 2018 as compared to Rs. 480.15 as on May 31, 2018 on account of Establishment Inspection Report (EIIR) received from the US FDA for its Halol facility (Gujarat). The US FDA has closed the issues contained in the warning letter issued in December 2015. Now the company can export its products produced from this facility to US and increased its topline.

Lupin has received final approval for its nystatin and triamcinolone acetonide cream USP from US FDA during first week of June. Similarly, it launched generic tobramycin inhalation solution USP in the US. Tobramycin inhalation solution is the generic equivalent of Novartis Pharmaceuticals Corpn's Tobi. and is indicated for the management of  cystic fibrosis patients with P. aeruginosa. Lupin also received US FDA approval for generic drospirenone, ethinyl estradiol, levomefolate calcium tablets and levomefolate callcium tablets from US FDA on June 14. These are the generic equivalent of Bayer's Beyaz tablets. With this approvals, Lupin share increased by 18.5 per cent to Rs. 910.40 on June 15, from Rs. 768 on May 31, 2018 on BSE.  

Cipla shares went up by 16.7 per cent to Rs. 612 on BSE yesterday as it received final approval for generic isuprel (isoproterenol hydrochloride injection USP), single-use sterile ampoule from US FDA on June 13, 2018. This is Ap-rated generic therapeutic equivalent version of Hospira Inc's Isuprel injection. According to IQVIA (IMS Health), Isuprel injection and its generic equivalents had US sales of app. USD 148 million. For the 12-month period ending April 2018. Cipla recently entered into agreement with Unitaid to reduce the prices of the first combination therapy (containning co-trimoxazole, isoniazid and vitamin B6) that prevents opportunistic infections in people living with HIV. 

Cadila Healthcare shares price moved up by 10 per cent to Rs. 398.50 last Friday from Rs. 362.30 on May 31, 2018 as it received final approval for doxycycline hyclate capsules USP from US FDA. It is a tetracycline antibiotic used for treatment of a wide variety of bacterial infections, including those that cause acne. This medication is also used for prophylaxis of malaria. It will be manufactured at the group's manufacturing facility at SEZ, Ahmedabad. Further, the US FDA has given clearance after inspection for its wholly-owned subsidiary, Alidac Pharmaceuticals Ltd, located at SEZ Ahmedabad. The company also received final approval from the US FDA for nystatin ointment USP and omeprazole and sodium bicarbonate capsules. It is used as an adjunct to treat fungal skin infections. 

Dr Reddy's Laboratories, share went up smartly by 20.8 per cent to Rs. 2351.10 from Rs. 1946.80 on May 31, 2018 as it received US FDA final approval for buprenorphine and naloxone sublingual film. The company is launching these products in the US market.  This is a therapeutic equivalent generic version of Suboxone sublingual film. Suboxone brand had US sales of app. USD 1.86 biollion MAT for the most recent twelve months. 

Alembic Pharma and Granules India have received establishment inspection report from US FDA recently. Alembic Pharma shares went up by 21.6 per cent to Rs. 518 on June 15, 2018 from Rs. 426.05 on last day of May 2018. Similarly, Granules share increased by 13.2 per cent to Rs. 89.05 from Rs. 78.65.

The shares of few MNCs like Glaxo Pharmaceuticals, AstraZeneca, Pfizer, Merck, Novartis and Sanofi improved during last 15 days. However, Abbott India shares declined.

Source: pharmabiz.com

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