Tuesday, 31 May 2011

Ubichem Research acquired

The majority share of Ubichem Research has been acquired by Lochlomond Holding, a financial investment company. The company is now independent of Ubichem Plc in the UK.
Outsourcing Pharma

SCM Pharma will manufacture Speciality European Pharma's oncology product Plenaxis for commercial supply

Outsourcing Pharma

Sunday, 29 May 2011

FDA launches inspections database

The US FDA has launched an Inspections Database. The searchable resource includes names and addresses of inspected facilities, inspection dates, types of FDA-regulated products involved, and final inspectional classification.

Gallus BioPharmaceuticals will use Xcellerex's FlexFactory GMP manufacturing platform suite at its St Louis, MO, facility


Monday, 23 May 2011

CIA seeks companies for UK pavilion at CPhI

The UK's Chemical Industries Association is seeking UK-based companies offering products and services within the fine chemical industry for a UK pavilion at CPhI in Frankfurt, Germany, during October.
For more information contact CIA

Almac has dedicated its new North American headquarters

Philadelphia Inquirer

Lactosan will manufacture some enzymes for Codexis and its customers


Thursday, 19 May 2011

Gallus acquires site, plans expansion

Gallus Biopharmaceuticals has acquired Johnson & Johnson's Centocor biologics campus in St Lousis, MO, following an equity investment by Ridgemont Equity Partners. Ridgemont has taken a majority stake in Gallus. Gallus will retain 160 jobs at the facility and plans to expand the facility’s manufacturing capabilities, including building a clinical services suite and expanding the existing development lab, and add 160 further jobs over the next five years.
St Louis Today

Wednesday, 18 May 2011

Lonza expands in Houston

Lonza will build a state-of-the-art cGMP clean room for its viral-based therapeutics business in Houston, TX. The clean room will include large-scale capacity to support late-stage viral vaccine and gene therapy projects. By utilising disposable process systems it will support production and fill/finish operations of up to 2000L.

Pfenex has submitted a Biologics Master File (BMF) to the FDA for its cGMP grade carrier protein for vaccine production


Tuesday, 17 May 2011

Codexis transfers processes to Teva

Codexis has completed the technology transfer of custom biocatalysts for manufacture of three pharmaceutical products to Teva. Two products have been transferred to pilot manufacturing and a third to full scale commercial manufacturing. Codexis' biocatalysts are being used in reengineered process steps in the manufacture of covered generic products
In-pharma Technologist

Monday, 16 May 2011

Fine chemicals revenues decline at Ampac

Revenues for American Pacific's fine chemicals division fell from $43.2m in 2010 to $30m in 2011 for the six months ended 31 March. The company said this was primarily due to a 92% decline in revenues from anti-viral products, which the company expects to resume in the second half of 2011.

Successful inspection at CML facility

Cambridge Major Laboratories has undergone a successful FDA inspection at its two manufacturing sites. The inspection of its Germantown, WI, large scale facility is the first at the site. The company also said the FDA has approved the product, which is the first commercial product produced in the large scale facility.

Cristin Grove has been appointed as director, Global Contract Manufacturing at Pfizer CentreSource

Contract Pharma

Lonza to expand cytotoxic manufacturing in Visp

Lonza will invest CHF24m to expand its cytotoxic manufacturing capabilities in Visp, Switzerland. The company will add multi-kilogram scale cytotoxic production capacity, which will allow it to offer clinical and commercial production, to its current gram scale high potency GMP laboratory suites. The expansion is expected to be completed in Q2 2012.

Gallus Biopharmaceuticals is closing this month on financing for its acquisition of Johnson & Johnson’s Centocor Biologics campus in St Louis

St Louis Business Journal

SAFC will perform process validation and clinical and commercial manufacturing for Oncolytics Biotech's Reolysin, reovirus

Winnipeg Free Press

Synthetech and Oregon State university have launched a new organocatalyst for use in pharmaceutical production


SynCo Bio Partners will manufacture Syntaxin's drug candidate SXN101959 for non clinical and clinical trials

Pharmaceutical Business Review

Monday, 9 May 2011

Six inspections at Hovione plants

Hovione facilities have undergone six successful GMP inspections in the last eight months. Sites in China and Portugal have been inspected by the Japanese PMDA; the Portuguese authorities inspected a site in April and the US FDA inspected the Loures site twice and New Jersey once.
PR Newswire

DSM and Roquette are to build a 10,000 tonne/year plant for the production of bio-based succinic acid in Cassano Spinola, Italy


Sales for Wacker Biosolutions in Q1 grew 10% to €37.7m with strong demand for products used in pharmaceutical and agrochemical applications


Q1 sales rise at Cambrex

Q1 2011 sales at Cambrex rose 9.8% to $61.7m compared to 2010. The company said the increase was due to higher sales of an API to a customer who resolved their supply chain disruption, higher volumes of generic APIs and increased volumes for a recently approved product.

Wednesday, 4 May 2011

Aptuit will provide manufacturing scale-up services for Iroko Pharmaceuticals' novel pain medications for Phase III clinical trials

Iroko Pharmaceuticals

Q1 contract revenues grow for AMRI

AMRI saw revenue growth in Q1 2011 driven by its contract manufacturing business. AMRI's development and small scale manufacturing revenue grew 24% to $10.5m and large scale manufacturing revenue grew 22% to $21.8m. The company has recently resumed GMP production at its Burlington, MA, facility and is working with the FDA to close out the Warning Letter as soon as possible.

SAFC will manufacture the API for Pro-Pharmaceuticals' lead product candidate for anticipated use in clinical trials and sales in Colombia


Tuesday, 3 May 2011

Cambridge Major Laboratories has appointed Rick Proehl as Vice President of Manufacturing


CMC Biologics has appointed Claes Glassell as CEO

CMC Biologics

Carbogen-Amcis HPAPI facility meets standard

Carbogen-Amcis' new high potency API facility in Ahmedabad, India, has completed a containment performance evaluation. The facility, which is located on the Dishman Pharmaceuticals and Chemicals site, meets category IV standards.