Sunday December 17, 2017

Dr Reddy’s subsidiary gets approval from USFDA

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Hyderabad: A subsidiary of Dr Reddy’s Laboratories Limited, Promius Pharma LLC has got an approval for (betamethasone dipropionate) Spray from the (USFDA) US Food and Drug Administration.


Sernivo Spray, a prescription topical steroid, is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. The commercial launch of the product is planned for the coming quarter, Dr Reddy’s announced on Monday.

“The FDA approval of Sernivo Spray is a significant milestone for Promius as it validates our committed efforts and resources to developing differentiated dermatology products from concept to commercial launch. We are delighted to receive a first round of FDA approval of Sernivo Spray as we look to expand our portfolio of medical dermatology products available in the US market,” said GV Prasad, co-chairman and CEO, Dr Reddy’s Laboratories.

Raghav Chari, executive vice-president of Proprietary Products at Dr Reddy’s and president of Promius Pharma said, “As an emerging leader in the dermatology space, we are committed to developing innovative treatment options and support services for clinicians and patients. The approval of Sernivo emphasises our ongoing efforts and we look forward to a successful launch of Sernivo Spray in the coming quarter.”

Through its three business verticals-Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products, Dr Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations.

Promius conducted two successful multi-center, randomised, double-blind, vehicle-controlled clinical trials in subjects aged 18 years and older with moderate plaque psoriasis to evaluate the safety and efficacy of Sernivo Spray. In both trials, randomised subjects applied Sernivo Spray or vehicle spray to the affected areas twice daily for 28 days.

Enrolled subjects had body surface area of involvement between 10% to 20% and an Investigator Global Assessment(IGA) score of 0 to 1(clear or almost clear) and at least, a 2- scale reduction from baseline), according to the company.

On day 29, in studies 1 and 2, Sernivo achieved treatment success of 42.7% and 34.5% compared to vehicle success rates off 11.7% and 13.6%, respectively, it said.(IANS)(image: casewareanalytics.com)

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Sun Pharma Gets Warning Letter from USFDA

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New Delhi: Sun Pharmaceutical Industries has received a warning letter from the US drug regulator (USFDA) over violation of manufacturing norms in its facility at Halol in Gujarat on Saturday.

Inspection of the facility in September 2014 by US Food and Drug Administration (USFDA) inspectors is followed by the warning letter.

Before the September 2014 inspection, USFDA has approved the future products from the Halol facility. This might continue until all the issues are resolved.

“Sun Pharma expects to request a re-inspection by USFDA upon completion of its remediation commitments,” the company said.

It further added that it will continue to supply its product to its customers to meet its commitment towards customers and patients.

“Sun Pharma will respond to this Warning Letter with a detailed plan within the stipulated timeframe,” it said.

Sun Pharma Managing Director Dilip Shanghvi commented “While our team is working hard to ensure that the commitments made to the USFDA in September 2014 are fully completed, we will continue to cooperate with the USFDA and undertake any additional steps necessary to ensure that the US agency is completely satisfied with our remediation of the Halol facility.”

“We are pledged to being cGMP compliant and are committed to continuing to supply our customers and patients across the world with quality products that meet all specifications,” He added.

Sun Pharma responded to the USFDA inspection observations with a “robust remediation process that is still ongoing, with significant investments in automation and training to enhance its Quality Systems”.

The company was working with some external consultants to ensure remediation activities completed in an appropriate manner, it added.

Since the inspection of September 2014, the company has communicated regularly with the USFDA on the progress of its remediation and on issues of product supply.(IANS)

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Indian drug makers to go for more overseas buys

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photo credit: www.indiatrendingnow.com

By NewsGram Staff Writer

Chennai: Indian pharmaceutical majors are expected to be on a search for greater overseas purchase as domestic drug makers have entered the consolidation phase in the global pharma industry, a research report from Jefferies stated.

photo credit: www.businesstoday.in
photo credit: www.businesstoday.in

In its research report on the Indian healthcare sector, Jefferies said the global pharma consolidation has continued unabated this year.

In 2015, there has been mergers and acquisitions (M&A) worth $110 billion which is on track to exceed last year’s record M & A of $140 billion, Jefferies said.

“Over the past year Indian companies have also joined the consolidation phase with Cipla and Lupin announcing large US generic acquisitions,” the report said.

According to the report, Indian players have done M & A worth $2 billion in 2015.

“With global players like Teva, Mylan increasing their size and relevance, Indian players also need to inorganically grow their portfolios. We expect players like Lupin, Dr Reddy, Torrent to be on the lookout for more acquisitions. Valuations though would be a major concern as price of assets have seen a sharp rise in past couple of years,” the Jefferies report stated.

According to the report with the pace of US Food and Drug Administration (USFDA) approvals remaining muted and the global consolidation progressing unabated, M and A by Indian drug companies has increased and the trend is expected to continue.

Though the USFDA approvals have picked up pace it is well below the requirements.

The abbreviated new drug application (ANDA) approvals by USFDA has remained strong for the past five months with 49 ANDAs approved every month against the historical average of 37, the report said.

According to Jefferies, the preference is for Indian companies that are not dependent on US approvals or inorganic drivers for growth.

“Sun Pharma remains our preferred pick among the large caps as we expect earnings to improve going forward led by improvement in Halol supplies and lower Ranbaxy integration expenses. We remain cautious on Lupin as we believe growth will be muted and risks of acquisition at premium valuations are high,” the report said.

While the depreciation of Indian currency is positive for the domestic pharma sector, the benefits have been offset by the appreciation of Indian rupee against European currencies, the research report added.

(With inputs from IANS)