Thursday, 25 October 2012
EU confirms API import rules
The European Union (EU) has confirmed its new rules regarding the import of APIs into member states. From 2 Jan 2013 all imported APIs must have been manufactured to an EU-equivalent GMP and by 2 July 2013 the importer will need to request and receive written confirmation of this compliance from the relevant regulatory authority.
Pharma Times
Tuesday, 16 October 2012
Dottikon to expand
Dottikon plans to increase its process development and optimisation capacities by 20% and extend its high-pressure technology in heterogeneous and homogeneous catalysis. The company expects the new capacity to be available in H2 2013. Additionally the company will strengthen and expand its catalysis group, including the development and acquisition of high-pressure parallel screening equipment. The company has terminated its talks with Solvias.
Speciality Chemicals
Pharma looks back to the west
Speaking at CPhI Albemarle’s director of fine chemistry services David DeCuir said that the pharma industry is looking back to western suppliers as a result of quality issues, potential interruptions with supplies from Asia and rising costs.
In-pharma Technologist
Wednesday, 10 October 2012
Novasep to build commercial scale chromatography plant
Novasep is investing €30m to build a commercial API chromatography plant in Mourenx, France, to address its projected demand for a large volume, highly purified APIs. The company said it expects the facility to be operational within 18 months.
GEN
Almac readies API manufacturing expansion
Almac has almost completed the expansion of its API manufacturing facility in Craigavon, UK. The upgraded facility, which will be operational by the end of the year, includes the installation of two 1000L reactors and state-of-the-art pressure filter dryer.
Almac
Almac and DSM to collaborate in biocatalysis
Almac and DSM Pharmaceutical Products will partner their biocatalysis capabilities for the manufacturing of APIs. Almac said its expertise in rapid enzyme identification, scale-up and implementation into early phase projects complements DSM’s experience and track record of over 30 commercial manufacturing bioprocesses run on a multi-ton scale.
Pharmaceutical Business Review
Sunday, 7 October 2012
Lonza-Teva biosimilar on hold
Teva has suspended its phase III study of a biosimilar of Rituxan, which it os jointly developing with Lonza. Lonza's shares fell as the company said the partners are evaluating how to move forward with testing as the regulatory environment for biosimilars gets more restrictive.
Fierce Biotech and Business Week
BASF relocates pharma ingredients to New Jersey
BASF will centralise the management of its Pharma Ingredients and Services business unit in Florham Park, NJ. The unit, which was previously managed from Evionnaz, Switzerland, will be led by Scott Thomson as Senior Vice President. BASF said the relocation of management will not affect the regional business and production units in Europe, including Evionnaz.
New Jersey Star Ledger
SAFC expands in Irvine
SAFC will add a powder manufacturing line at its Irvine, Scotland, facility. The expansion will be supported with a £1.5m grant from Scottish Enterprise and will create 24 new jobs.
St Louis Business Journal