Thursday, 18 September 2008
Wednesday, 17 September 2008
Pharmatek opens high potency facility
Pharmatek has opened its 1800m2 highly-potent and cytotoxic facility in San Diego. The new development includes analytical and formulation development laboratories and cGMP manufacturing suites.
Pharmatek
Tuesday, 16 September 2008
DSM-LibraGen amine technology deal
DSM and LibraGen will co-develop new omega-transaminases for production of chiral amines. LibraGen will use its enzyme discovery and development to identify enzymes to convert ketones to optically pure amines. DSM will produce the enzyme using its fermentation capabilities and PluGbug expression platform.
LibraGen
Significant growth in Excelsyn sales
Excelsyn saw like-for-like sales increase 43.5% to $28m for its year ended 31 May. The company attributed the growth to an acceleration in volume demand and customer numbers for its pharma synthesis business and continuing growth in outsourcing of development and manufacturing services. Excelsyn ceo Ian Shott said the company's strategy, introduced in January, was delivering a significant upturn in business.
Excelsyn
Thursday, 11 September 2008
Lonza expects more outsourcing, plans acquisitions
Lonza CFO Toralf Haag has said the company expects to benefit from the pharma industry's continuing trend towards more outsourcing. He also said the company has CHF1.5bn-2bn ($1.3bn-$1.8bn) available for acquisitions in the next year.
The Guardian
Tuesday, 9 September 2008
FDA revises cGMP guidelines
The FDA has amended its cGMP requirements for finished pharmaceuticals. This amendments concern aseptic processing, verification of performance of
operations by a second individual, and the use of asbestos filters. The FDA said it changes were to "modernise or clarify some of the requirements as well as to harmonize them with other FDA regulations and international cGMP standards". The amendments which are the first phase of an incremental approach to modifying the cGMP regulations will be effective from 8 December 2008.
FDA
Sunday, 7 September 2008
SOCMA plans for "Last 100 days"
SOCMA intends to ensure that legislation key for the success for its members does not fall by the wayside during the last 100 days of the Bush Administration. SOCMA will be meeting regulatory agencies overseeing unfinished business to urge completion of its priority issues as well as ensuring that the McCain and Obama campaigns are aware of these issues.
SOCMA
SAFC confirms HP-API expansion plans
Sigma-Aldrich has confirmed plans for a $30m expansion of its SAFC high potency API facility in Madison, Wisconsin. SAFC has purchased 15 acres of land in Verona, Wisconsin, for the 4500m2 facility, which will include development laboratories, a 150L mini-processing plant and two large-scale cGMP manufacturing suites with reactors up to 4000L. Construction is expected to be completed by end-2009.
In-Pharma Technologist
Dishman plans Carbogen Amcis IPO
both acquired by Solutia in 2000. Solutia rebranded the businesses as Solutia Pharmaceutical Services before formally merging them into a single legal entity: Carbogen Amcis in 2006. Dishman acquired Carbogen Amcis from Solutia in May 2006 and has made a number of investments in the business over the past two years.
Sify Business
