Wednesday 20 July 2016

Glenmark Pharma working on proprietary product rollout and other top pharma news

Sun Pharma today announced that one of its subsidiaries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Crestor® , Rosuvastatin Calcium tablets 5 mg (base), 10 mg (base), 20 mg (base) and 40 mg (base).

Doctor prescription and medicine
Glenmark Pharmaceuticals plans to to launch a number of proprietary products over the next decade as part of Its objective to become a specialty-driven firm. The company's long term focus Is to “launch Innovative and specialty products across markets with significant share of revenues coming from specialty and Innovation segment”, Glenmark Pharmaceuticals said In Its latest Investor presentation. It will also focus on organic growth and leveraging Internal capabilities across markets. It added. In the medium term, the emphasis Is on “continuing to grow base generics business" with the US, India and Europe to be main growth drivers, Glenmark said. 

Sun Pharma today announced that one of its subsidiaries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Crestor® , Rosuvastatin Calcium tablets 5 mg (base), 10 mg (base), 20 mg (base) and 40 mg (base).

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Rosuvastatin Calcium Tablets, 5 mg (base), 10 mg (base), 20 mg (base) and 40 mg (base). Aurobindo was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification, therefore, Aurobindo is eligible for 180 days of generic drug shared exclusivity. The product is launched in the US market.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Rosuvastatin Calcium Tablets,5 mg (base), 10 mg (base), 20 mg (base), and 40 mg (base), the generic version of Crestor Tablets, 5 mg,10 mg,20 mg,and 40 mg of IPR Pharmaceuticals, Inc. (IPR).
Government has not given permission to any pharma firm to increase prices of drugs beyond permissible limits, Parliament was informed yesterday.

Johnson & Johnson posted second-quarter profit earnings that beat analysts’ estimates, aided by the growing pharmaceutical division that is home to blockbuster products such as arthritis treatment Remicade. Remicade accounts for more than 21 per cent of drug revenue. 

To increase pharmaceutical export to the US, industries and the government should innovate and invest more on research and development of new drugs, say industry experts. Speaking at a seminar on ‘The march towards $500 billion trade’ organised by the Indo- American Chamber of Commerce, J Jayaseelan, Chairman, Indian Drug Manufacturers Association - Tamil Nadu, said though the country leads in terms of generic drug manufacturing impetus should be given to drug discovery to boost exports. India exports $5 billion worth generic drugs to the US, accounting for about 40 per cent of the drugs in the US market. India is the third largest exporter of generics but ranks 14th in terms of value. “Focus on drug discovery and capability building will increase the value of Indian drugs and improve exports,” Jayaseelan said. 

Ticel Biopark III in Coimbatore, the third such park in Tamil Nadu, is expected to be ready in 18 months, said Tamil Nadu Industry Secretary CV Sankar. Tamil Nadu was one of the first States to establish a biopark (Ticel I) for pharmaceutical and life science sectors in 2004, he said at the Indo-US Partnership Conclave – the march towards $500 billion trade – organised by the Indo-American Chamber of Commerce. 

Heightened uncertainty about the global economy following Britain’s decision to exit the European Union has dimmed the prospects of technology and select pharma stocks. Analysts are advising clients to avoid committing fresh money to most software stocks amid ambiguity about the impact of political risks of technology spending following Brexit. The Nifty IT Index has dropped 6.70% in the last month and fallen 4.72% in the last year. The Nifty Pharma index has risen 8.15% in the last month but has dived 12% in the last year. “I am not bullish on IT and pharma sectors owing to global volatility post-Brexit and cross-currency headwinds,” said Ritu Arora, director – investment, Canara HSBC Oriental Bank of Commerce Life Insurance. 

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