The European Medicines Agency (EMA) has recommended a recall of Acino’s generic Plavix (clopidogrel bisulfate) because of alleged failings in GMP at the API production facility.
The UK budget was “a missed opportunity” to encourage manufacturing, according to UK Chemical Industries Association (CIA), but was free from unexpected tax increases.
Contract manufacturing organization (CMO) ScinoPharm says strong anticancer API sales and growing demand in Europe and Asia were key to record performance in 2009.
Liquent and Take Solutions say their new partnership provides pharmaceutical firms with an efficient, cost effective outsourced solution for regulatory publication and submissions.
The increasing incidence of chronic and “lifestyle” related disorders will fuel demand for inhalable delivery technologies over the next five years, according to a Global Industry Analysts (GIA) report.
The IPEA's issuance of good manufacturing practice (GMP) “certification” is mark of manufacturing quality, says US specialty chemicals supplier W R Grace & Co.
Industrial glass maker Schott ended a “rather difficult” fiscal 2009 with a loss but says rise in drug packaging sales will help drive double-digit earnings growth in current financial year.
New specialist development and manufacturing “centres of excellence” increase efficiencies and customer access to expertise, DPT Laboratories spokesman tells Outsourcing-pharma.
Dr Reddy’s has made a “significant investment” in an mPEG alcohol production facility in Mexico to strengthen its presence in a sector it believes is on the rise.
The Botswanan government is seeking to initiate local pharma manufacturing, which would lower drug prices, by entering into public-private partnerships (PPP), according to a report by F&S.
Outsourcing to Asia is changing “from a tactical to a strategic imperative” as a result of the region gaining the capabilities needed to perform work high up the biopharma value chain, according to Quintiles.
Ireland must become an R&D hub as well as a drug manufacturing destination to prosper in the increasingly competitive global pharmaceutical market, says industry body PharmaChemical Ireland (PCI).
Indian CRO GVK Biosciences hopes new clinical pharmacology unit in Ahmedabad will help boost patient recruitment to meet growing demand for clinical trials in the region.
Quintiles has relocated its global central laboratory in Japan to meet rising demand from the local market and US and European pharmas keen to include the country in their clinical trial network.
The Chinese government is supporting a $100m (€73m) project to build a contract biologics production facility in Beijing, which, by some measures, would be the largest in Asia.
E Research Technology (ERT) launches Centralised Cardiac Safety 2.0 (CCS 2.0) service for ECG data and says approach improves efficiency, cuts costs and helps sponsors reach database lock quicker than distributed model.
Stason Pharmaceuticals’ subsidiary Standard Chem and Pharm will act as primary distributor for the Unitract 1ml safety syringe in China, Japan and Taiwan under a five-year new deal with US delivery device maker Unilife.
Kendle has implemented a centralised biostatistics platform which will “create significant time savings” by improving global access to clinical trial data, according to the company.
WuXi PharmaTech posted an operating profit of $52m (€38m) in 2009 and is optimistic about 2010, when it will make investments in laboratory services and large-scale manufacturing to drive growth in coming years.
Indian generic drugmaker Aurobindo Pharma officially launched its CRAMS unit AuroSource last week, also unveiling plans for an R&D facility in Pashamylaram near Hyderabad, India.
Payne Security has acquired BP Secure Solutions, adding the UK firm's roster of adhesive security labelling technologies to its drug industry offering.
Kendle is setting up a facility in a special economic zone (SEZ) in India which will provide clinical support services and be able to rapidly increase staffing in response to spikes in demand.
Bayer Technology Services (BTS) has set up a new Singapore office to provide the regions’ drug and chemicals producers with engineering consultation services and micro reaction technology.
A significant share of contract API maker ScinoPharm Taiwan is set to change hands after Watson Pharmaceuticals decided to sell its stake to Uni-President Enterprises Corporation.
WuXi PharmaTech is collaborating with J&J Pharmaceutical R&D, providing the pharma with toxicology services and receiving training to establish GLP at its facility in Suzhou, China.
US CRO PPD has been busy on both sides of the Atlantic, opening a clinical testing facility in Ireland and, in the US, moving forward with plans to spin-off its compound partnering business as Furiex Pharmaceuticals
US FDA clearance for Italian antibiotics production facility is important for global growth says German contract development and manufacturing organisation (CDMO) Haupt Pharma.
Lek has opened a 430m² modified protein manufacturing facility in Slovenia to produce epoetin alfa drug substance for use in the biosimilars marketed by its parent company, Sandoz.
Parexel has opened a 40 bed early phase clinical trial unit in South Africa, increasing its Phase I capabilities in the country and adding to its patient recruitment focused SuperSites network.
The FDA has issued Eli Lilly with a warning letter detailing a significant deviation from cGMP at its API production facility in Puerto Rico, which makes ingredients used in Humalog (insulin lispro), a diabetes treatment.
In the economic downturn biotechs have cut back on outsourcing to Asia and opted to use the US instead because they lack the resources to manage overseas relationships, according to a SOCMA representative.
Helvoet Pharma is to build a €14m ($19m) rubber parenteral packaging component facility in India to meet rising demand for products made to international quality standards.
Aesica is looking to acquire manufacturing assets in the US to expand its client base in the country and continue the growth it has maintained throughout the economic downturn.
US Pharma firms can benefit from the sourcing, storage and distribution efficiencies offered by comparator drug sourcing and distribution specialist Pharmarama says managing director Rosemary Bensley.
There are signs that 2010 will be a better year for the fine and custom chemistry industry but companies at Informex remained cautious and are planning accordingly.
The Chinese API sector shrank last year after a number of high profile quality problems hit demand from Western markets, according to new analysis by outsourcing consultant JZ Med.
Contract API maker Ampac Fine chemicals (AFC) has had a busy 24-hours, entering the Japanese market through a deal with Inabata and forging an alliance with Codexis on biocatalyst technology.
Almac Clinical Services says novel temperature monitoring system speeds shipping and cuts quarantine times by allowing authorised personnel to make decisions on trial supplies at clinical sites 24/7.
The impact of the economic downturn is still being felt but SAFC remains "cautiously optimistic" about 2010, believing its close relationships with clients and investment in key emerging markets will generate business.
Global contract research organisation (CRO) Quintiles hopes its anatomical pathology offering will attract the growing number of drugmakers developing cancer drugs for China.
The capabilities of the MDS Pharma Services' sites Ricerca is set to acquire "perfectly dovetail" with its existing capacity, according to a company vice president.
Communication is a vital aspect of the relationship between CMOs, CROs and their clients, with a single point of contact who quickly informs sponsors of problems a necessity, according to a panel at Informex 2010.
Indian drugmaker Elder Pharmaceuticals says its new manufacturing plant in Dehradun, Uttarakhand State will boost sales 15 per cent and provide capacity for expansion in overseas market.
Clinical trials are often biased against the recruitment of older people says the European Union's PREDICT group, which has launched a charter designed to protect such patients' right to take part.
