Thursday, 30 October 2008
Shasun to close Scottish plant
Shasun Chemicals & Drugs Ltd will close its Annan, Scotland, facility by March 2009. The facility, run by UK subsidiary Shasun Pharma Solutions Ltd, was acquired from Rhodia in 2006.
Financial Express
Wednesday, 29 October 2008
AMRI expands in India
Albany Molecular Research has expanded its Aurangabad, India, manufacturing facility with the addition of a 1000L non-GMP multipurpose pilot plant. The company said the plant will be used to produce starting materials and intermediates for its manufacturing facilities in the US and reduce the company’s reliance on third-party resource providers.
Albany Business Review
Biotech woes hit Lonza
The financing difficulties currently facing small and start-up biotech companies are hitting Lonza. The company warned it may miss its mid-term earnings target in 2008 and may not be able to offset weaker economic growth in the second half. The company expects the macroeconomic challenges to continue in 2009.
Reuters
Dishman takes loan
Dishman Pharmaceuticals and Chemicals Ltd is funding expansion projects through a loan from the International Finance Corp. Dishman will use the loan to build new facilities at its Bavla manufacturing site, invest around $10m to establish a manufacturing facility in Shanghai, China, and invest in overseas subsidiaries and joint ventures.
Sindh Today
Piramal sees Indian growth
Nicholas Piramal's custom manufacturing business has seen strong growth, 11%, in the first half of its 2009 year. Revenues from its Indian facilities grew 55% to Rs1.5bn.
Nicholas Piramal
SAFC sees decline
SAFC Pharma, the fine chemicals business of Sigma-Aldrich saw a decline during Q3 as a result of spending cutbacks in the pharmaceutical sector. Kirk Richter, Sigma-Aldrich's Treasurer and Investor Relations executive, said that "customers have either deferred committed orders or not repeated the business we've enjoyed in the past". He did remain optimistic going forward.
Seeking Alpha
Borgas: Consolidation and closures required
Stefan Borgas, ceo of Lonza, believes that there is 60% overcapacity in pharmaceutical manufacturing for chemical ingredients with a highly fragmented industry. Borgas believes that some niche capabilities may offer protection, but ultimately there needs to be consolidation in the sector along with plant closures and modern, more efficient plants being built. He also warned that the biologics manufacturing sector could follow the same "sinful path" towards fragmentation and overcapacity.
In-Pharma Technologist
Thursday, 23 October 2008
FDA inspection rate is slow
The US Congress has revealed that FDA oversight of foreign plants producing pharmaceutical products for the US market leaves a lot to be desired. The investigation revealed that at current rates it will take 13 years to inspect the 3,249 plants currently providing products. The FDA takes about 2 years to inspect the 3,000 plants in the US.
Associated Press
Tuesday, 21 October 2008
FDA outlines overseas plans
FDA Commissioner Andrew von Eschenbach has laid out further details of the Agency's plans to establish more overseas offices during the next year. The first of these will open in China before the end of 2008. The FDA plans to have 60 regulators world-wide over the next year, with a particular focus on India, Latin America and the Middle East in addition to China.
Wall Street Journal
Thursday, 16 October 2008
Tuesday, 14 October 2008
Country of origin labeling proposed
The US Senate is considering a bill that will require the country-of-origin of APIs and excipients to be labeled on finished prescription and OTC products. The bill is different from the proposal in the draft of the US FDA Globalization Act as it includes excipients.
In-Pharma Technologist
New funds for Reaxa
Reaxa has completed a rights issue underwritten by its institutional investors, EV and YFM Private Equity. Reaxa will use the funds for sales and marketing expansion and for commercial scale production of its scavenger and EnCat catalyst ranges.
Reaxa
Friday, 10 October 2008
EFIG launches excipients project
The European Fine Chemicals Group (EFCG) and IPEC Europe have formed a European Pharmaceutical Excipients Certification Project to develop advocacy and stakeholder management in Europe for manufacturers and distributors of pharmaceutical excipients. EFCG also welcomed recent announcements and actions taken by the regulatory authorities on both sides of the Atlantic and in Japan to stem the flow of sub-standard and counterfeit APIs and medicines in the wake of the heparin disaster earlier this year. Finally, EFCG set out its implementation plan for a worldwide "Voluntary Guidelines for ISO-regulated Fine Chemical Manufacturers", which is a proposed set of minimum requirements for global manufacturers of non-pharma fine chemical intermediates and active ingredients.
EFCG
EFCG
EFCG
Almac offers solid state services
Almac has added a Solid State Chemistry business to its pharmaceutical operations. Based in Craigavon, Northern Ireland, the team specialises in solid form characterisation, screening and selection, in addition to crystallization process development.
Almac
CPhI Innovation award winners
Novozymes Biopolymer won the Gold award at the 2008 CPhI Innovation Awards for its HyaCare hyaluronic acid process. Pierre Fabre Medicament won the silver award for its Formulplex "green" formulation process and Dr Reddy's precatalyst fabrication technology the bronze.
CPhI
Thursday, 9 October 2008
Ferro sells fine chems unit
Ferro Corporation has sold its fine chemicals business to Arsenal Capital Partners for $66m. Following the deal, which is expected to close by the end of the year, the business will be renames Novolyte Technologies.
RTT News
Friday, 3 October 2008
Wednesday, 1 October 2008
SAFC commissions HPAPI facility
SAFC Pharma has commissioned a high-potency API conjugates suite at its St Louis site to support oncology drug development. The suite will accommodate early-stage clinical supplies with the capability to expand production up to commercial-scale.
Pharmaceutical Online
Aptuit streamlines early stage drug development
Aptuit has launched a new programme to speed the early stages of drug discovery. Indigo aims to support development from discovery through to proof-of-concept and includes API manufacturing, toxicology, metabolism/pharmacokinetics, clinical supplies and regulatory application.
Aptuit
SAFC increases API capacity by 15%
SAFC Pharma has begun operation of a new reactor at its Arklow, Ireland, site. The 6000L reactor, which is part of a $4m project, increases SAFC's API production capacity by 15%. SAFC is also carrying out two further enhavcements in Arklow: a $2.25m pilot-scale filter dryer due for commission in Q32009; and a $1.8m expansion of warehouse capacity due for completion in 2009.
Sigma_Aldrich
