IHS Chemical Week


Pharma/fine chemicals roundup—18 February 2014

3:42 AM MST | February 18, 2014 | By DEEPTI RAMESH

Aurobindo Pharma reports rise in API sales

The active pharmaceutical ingredient (API) business of Aurobindo Pharma (Hyderabad, India) reports a 12.7% rise in sales in the company’s fiscal third quarter, ended 31 December 2013, compared with the year-ago quarter, to 7.44 billion Indian rupees ($120 million). Earnings figures for the API business have not been disclosed. Aurobindo is one of the global leaders in APIs. Cephalosporin accounted for Rs2.17 billion of Aurobindo’s total API sales of in the fiscal third quarter, semisynthetic penicillin accounted for Rs2.58 billion, and nonbetalactam accounted for Rs2.68 billion. During the fiscal third quarter, 29 drug master files (DMFs) were filed globally, including one in the United States, Aurobindo says. A DMF is a confidential, detailed document submitted by API manufacturers to a regulatory agency; the file contains the chemistry, manufacturing, and controls of a drug component. For the nine-month period ended 31 December 2013, Aurobindo’s API business reports a 12.8% rise in sales compared with the year-ago period, to Rs21.09 billion.

API business of Dr. Reddy’s reports fall in sales

The pharmaceutical services and active ingredients (PSAI) business of Dr. Reddy’s Laboratories (Hyderabad, India) reports a 29% fall in sales in the company’s fiscal third quarter, ended 31 December 2013, compared with the year-ago quarter, to 5.06 billion Indian rupees ($81 million). Earnings figures for the PSAI business have not been disclosed. During the quarter, 19 DMFs were filed globally, including 6 in Europe, Dr. Reddy’s says. As of 31 December 2013, the cumulative DMF filings were 612. Europe accounted for about 38.5% of the company's PSAI sales in the quarter, North America for 15.4%, India for 18.6%, and the rest of the world for 27.4%, Dr. Reddy’s says.

Cedarburg Hauser appoints director of process development

Cedarburg Hauser Pharmaceuticals (CHP; Grafton, WI), a contract development and manufacturing organization specializing in small molecule APIs, says it has appointed Alex Tretyakov as its director of process development. In his new role, Tretyakov will lead CHP’s process and analytical development groups. Most recently, Tretyakov served as v.p./R&D at API manufacturing company PCI Synthesis (Newburyport, MA) and previously held the same position at pharma ingredients firm Cambridge Major Laboratories (Germantown, WI).

Sonneborn gets Excipact certification

Excipact says that Sonneborn Refined Products (Amsterdam) has received an Excipact certification from SGS, one of its certification bodies. The Excipact certification demonstrates that the Sonneborn site manufactures pharmaceutical excipients according to Excipact GMP and good distribution practice (GDP) certification standards. This is the first Dutch site to receive such certification. The other certified sites are in Germany and France—BASF site at Ludwigshafen, Germany; Merck KGaA site at Darmstadt, Germany; Aug. Hedinger site at Stuttgart, Germany; and Sepiprod site at Castres, France—Excipact says. Excipact, which was a project of the IPEC Federation (Brussels), became a free-standing, not-for-profit company at the end of January 2014.

Cambrex reports fall in profits

Cambrex (East Rutherford, NJ) reports a 79.6% fall in net profits for the fourth quarter of 2013, ended 31 December, compared with the year-ago quarter, to $8.89 million. The results for the fourth quarter of 2012 include tax benefits of $37.6 million, Cambrex says. Net sales for fourth-quarter 2013 increased 47%, however, to $102.4 million, primarily because of higher sales of a recently approved branded API and controlled substances, partially offset by lower sales of generic and other branded APIs and products using the company's drug delivery technology, Cambrex says. Fourth-quarter Ebitda increased to $22.2 million compared to $13.1 million in the same period in 2012. For full-year 2013, Cambrex reports a 58.4% decrease in net profits compared with 2012, to $25.91 million. Full-year sales for 2013 increased by 14.6% compared with 2012, to $315.8 million. Full-year adjusted Ebitda increased to $67.4 million in 2013 compared to $57.5 million in 2012.
“We are very pleased that 2013 was our third consecutive year of strong growth in both sales and Ebitda and believe we are positioned to deliver a similar level of growth in 2014,” says Steven Klosk, president and CEO of Cambrex.  “We made significant growth investments during 2013 and have built the strongest pipeline of custom development projects and opportunities that we have had in many years. In 2014, we expect to expand our footprint within our generics product category by continuing to add generic APIs to our development portfolio of 15 products, and by earmarking $2 million of additional R&D spending for projects where Cambrex expects to partner with one or more generic drug companies to codevelop finished generic drug products,” Klosk says.

BioOutsource partners with Glythera for ADCs

BioOutsource (Glasgow, UK), a contract testing organization, says it has amplified its position as a global leader in antibody drug conjugates (ADC) characterization through a partnership with Glythera (Newcastle, UK), a biotechnology company that specializes in the development of next generation biotherapeutics through the application of its proprietary linker and stable glycan technologies. “Building on our position as a leader in biological characterization of monoclonal antibodies, ADCs represent an exciting development which will enhance the performance of a wide range of therapeutic products.  We are delighted to partner with Glythera to characterize their ADC product in development, as we believe it holds considerable promise,” says Daniel Galbraith, chief scientific officer at BioOutsource.

Clariant’s healthcare packaging unit collaborates with Pumpart

Clariant, through its healthcare packaging business segment, has announced a partnership and collaboration with PumpArt System for the introduction of an innovative airless dispensing technology, Tubairless, to the pharmaceutical industry. Tubairless is a dispensing system that help protects sensitive cream-based formulas from the adverse effects of outside air, Clariant says.

Beyond IHS Chemical Week:

AMRI to focus on scale and capabilities of API biz following robust 2013
from in-PharmaTechnologist.com

AMRI says it intends to expand its API business to target both generics and more complex molecules after reporting record full year revenue from contract services.

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