Thursday, 21 June 2012

FDA seeks to secure supply chain

The US Food and Drug Administration is seeking 100 companies to volunteer to join the Secure Supply Chain pilot programme. The programme aims to promote the safety of drugs and active drug ingredients produced outside the US. Applicants will need to meet the programme's criteria, including a requirement that they maintain control over the drug products from the time of manufacture through entry into the country. The FDA hopes the programme will expedite the entry of products meeting the pilot's criteria into the US and allow it to focus its resources on foreign-produced drugs that fall outside the programme and that may not be compliant.
Regulatory Focus

Hovione reposted a 24% rise in sales for the year ended March 2012 to $180m, the sixth consecutive year of sales growth


Tuesday, 19 June 2012

Fujifilm Diosynth Biotechnologies to expand facilities in UK

Fujifilm Diosynth Biotechnologies is further increasing its contract process development and manufacturing capabilities through the expansion of its services in mammalian cell line development and process development, and the addition of a new multi-product cGMP facility in Billingham, UK. The company said work has commenced on a state-of-the-art cGMP cell bank and 1000L biologics manufacturing facility based upon single-use technology for both upstream and downstream operations. The cell bank manufacturing facility is expected to be available from Q2, 2013 and the mammalian cell culture biologics manufacturing facility is expected to be validated and fully operational in the second half of 2013.
Fujifilm Diosynth Biotechnologies

CMC Biologics' Bothell, WA, facility has received GMP certification from the UK Medicines and Healthcare products Regulatory Agency

PR Newswire

Codexis has been awarded the annual Presidential Green Chemistry Challenge Award for its simvastatin manufacturing process


DSM antibody deal

DSM Pharmaceutical Products will use its XD high cell density process technology to produce antibodies for a major pharma company at its Groningen, The Netherlands, and Brisbane, Australia facilities.
PR Newswire

Evonik IPO suspended


Lonza has completed the installation of a new GMP clean room in Houston, Texas, for its vaccines and gene therapy business


Piramal negotiating to acquire Cambridge Major

Piramal Healthcare is currently in negotiations to acquire Cambridge Major for around $200m. The report appears to confirm earlier comments by the company. A source lose to the situation, quoted in Financial Express, said "Early stage negotiations are on and it will take a while to conclude the deal." Cambridge Major has not commented on the speculation.
Financial Express

Dalton Pharma Services will manufacture chemicals for use in Clarity Pharmaceuticals’ PET-based companion diagnostics and radio-immunotherapeutics programmes

Pharmaceutical Business Review

Wacker Biotech has completed a feasibility study to produce XL-protein's PASylated therapeutic proteins


Wednesday, 13 June 2012

Ubichem adds capacity in Hungary

Ubichem has added a new manufacturing site in Budapect, Hungary. Ubichem Pharma Manufacturing's 55,0002 facility will produce starting materials, intermediates and other fine chemical products for pharma and non-pharma applications.

SAFC plans to consolidate its global chiral chromatography screening and small scale purification operations at its Pharmorphix laboratories in Cambridge, UK, by July


Evonik IPO may be cancelled


Thursday, 7 June 2012

The US FDA has sent warning letters to eight companies for failing to register manufacturing facilities

In-pharma Technologist

Strong sales for Johnson Matthey

Johnson Matthey reported that sales for its fine chemical division rose 16% to £285m and operating profit rose 24% to £69.7m. The company said this was boosted by strong demand and supported by a very strong performance from its API manufacturing businesses. Sales in API manufacturing rose 18% to £206m.
Johnson Matthey

Tuesday, 5 June 2012

Codexis has appointed John J Nicols as President and Chief Executive Officer


Siegfried adds sterile filling

Siegfried has acquired Alliance Medical Products in Irvine, CA, to add sterile filling services. Siegfried paid $58m in cash with a contingent earn-out consideration subject to AMP meeting defined profitability goals for the fiscal year ended December 31, 2013.

Profits fall at Angel

Angel Biotechnology has reported revenues of £3.456m for the peered ended 31 March. Profits fell from £1.9m to £1.2m partly as a result of the expenditure prepare its Cramlington facility for its initial MHRA inspection. The company plans to continue consolidating its businesses in the coming year.
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