The Challenge of Change - Managing Excipients Control
Colorcon
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The WHO has called for recall and destruction of all batches of Indian drugmaker Shantha Biotechnics’ Shan5 vaccine after the discovery of “white sediment” in some vials.
Pro-Tect (PRTT) says new technology patents could drive “revolution” in once-daily drug delivery for pain meds.
Pfizer will lose patent protection for Viagra in Brazil on June 20 after the Supreme Court (STJ) accepted recommendations by national intellectual property watchdog, the INPI.
The FDA has issued a letter to stakeholders detailing best practices for preventing and responding to theft of pharma products.
The US FDA says Teva Pharmaceutical Industries’ plan to fix cGMP violations observed at its plant in Irving, California “lack sufficient corrective actions.”
L’Oreal says that it is in ‘no hurry’ to sell off the 8.97 per cent stake in France-based consumer health care and pharmaceuticals player Sanofi-aventis.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including appointments at Roche, AVI BioPharma, Amgen and Delcath Systems.
Pevion Biotech has successfully completed preclinical safety and efficacy studies of its RSV vaccine candidate, which uses a virosome-based delivery platform.
The Chao Center for Industrial research and contract manufacturing is to close this year after failing to become a self sustaining enterprise.
Manufacturing problems at Mitsubishi Tanabe Pharma (MTP) have forced CEO Michihiro Tsuchiya to relinquish his vice presidency of the Japanese Pharmaceutical Manufacturers Association (JPMA).
AstraZeneca will pay $520m to the US government to settle a federal investigation into the marketing of its blockbuster antipsychotic Seroquel.
The USP and FDA must work to identify counterfeited or intentionally adulterated products before they enter the healthcare system by collaborating on the modification of monographs, according to Margaret Hamburg.
US firm SAFC plans to turn its dry powder culture media manufacturing plant in Lenexa, Kansas into a “centre of excellence” with $6.3m (€4.7m) capacity expansion.
US drug packaging firm Comar says acquisition of Universal Container Corp (Unicon) provides capacity for growth, particularly in key liquid medication delivery device market.
Demand for HPAPIs helped US life science and technology supplier Sigma-Aldrich to a positive set of first quarter financials.
Colorcon has acquired excipient business NP Pharm, adding sugar spheres to its portfolio and production capacity that will become “an integral part” of its manufacturing network.
The incoming Xcellerex CEO plans to move the company from validation to penetration, boosting revenues and client base, and invest in the contract manufacturing side of the business.
Microfluidics chose Interphex 2010 in New York, US to unveil a new processing technology that it claims can help manufacturers save time and money by switching from batch to continuous particle production.
ATMI is using Interphex 2010 to launch the Integrity PadReactor, a disposable bioreactor designed to provide a highly scalable entry point in its line of mixing and process manufacturing systems.
Delegates lucky enough to have made the trip to Interphex 2010 in New York, US bore witness to the launch of a wide range of new drug manufacturing technologies with products by O'Hara, Corning and PTI being some of the highlights.
Pall Life Sciences has completed work on a expansion of its manufacturing and R&D facility in Florida, US creating 50 new jobs.
Pfizer failed to ensure proper monitoring of a clinical trial in which in number of patients received overdoses, according to the US Food and Drug Administration (FDA).
Capacity at Blu Pharmaceutical’s recently acquired solid dosage production plant in Puerto Rico is set to expand considerable over the next three years according to company president Bill Luster.
Demand in “Pharmerging” markets will offset declining revenues from off-patent blockbusters and drive prescription drug sales to $1.1tr (€819bn) by 2014, according to IMS Health.
A project bringing together researchers from academia and pharma companies, including GSK and AZ, has received a £709,000 ($1.09m) grant to create crystals using continuous flow production.
Irish drugmaker Elan has once again raised the possibility of selling its delivery business, Elan Drug Technologies (EDT).
Sandoz will buy generics firm Oriel Therapeutics, adding the US company’s FreePath delivery system and Solis multi-dose dry powder inhaler to its respiratory drug technology portfolio.
Biocatalysis specialist Codexis aims to raise $103m in another initial public offering (IPO) on the Nasdaq Global Market.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including appointments at Baxter, Dendreon, Roche, Somaxon and Silence Therapeutics.
in-PharmaTechnologist presents exclusive interactive maps of pharma manufacturing facilities in India, detailing the number of bulk drug and formulation facilities in each region of the country.
AMPAC Fine Chemicals boosts reactor capacity 30 per cent with new manufacturing plant and says North America is attractive for API production.
Air travel disruption caused by the eruption of Iceland’s Eyjafjallajoekull volcano means that, to our considerable disappointment, in-Pharmatechnologist will not be at Interphex 2010.
More Dewas-related problems for Ranbaxy as the Indian generic drugmaker recalls an antibiotic in the US.
The EFPIA has hailed its 2-D data matrix anti-counterfeiting pilot scheme as a success and hopes to convince governments and supply chain actors of benefits of the approach.
The US Food and Drug Administration (FDA) has issued Apotex with another warning letter about cGMP violations at two plants explaining the firm’s response to previous warnings “is inadequate and lacks sufficient corrective actions.”
GE Sensing and Inspection Technologies has introduced an logger capable of covering a temperature range from -85ºC to 140ºC to provide a single tool for a variety of applications.
Becton Dickinson (BD) says its new Hungarian plant will be operational this year and producing more than 500m pre-fillable glass syringes by 2015.
US firm NuSil Technology says new clean room manufacturing plant will help meet growing demand for silicone compounds for delivery systems.
“Good business development” in the pharma and “slow spending” in the cyclical cosmetics and life sciences sectors dominated Gerreshimer’s performance in the first quarter of 2010.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including appointments at Xcellerex, Bristol-Myers Squibb and KV Pharmaceutical.
Hong Kong, China-based drug wholesaler Julius Chen & Co has been ordered to recall 300mg/tablet formulation of a gout treatment name Puricos (allopurinol) after DoH officials discovered the firm packaged it without a license to do so.
Canada made a “value judgement” in dropping its plans for a HIV vaccine plant, according to a representative of the public health agency who said the money could be better spent in other areas.
US drugmaker Javelin Pharmaceuticals says Hospira’s takeover bid is “superior” and terminates agreement with Myriad Pharmaceuticals (MPI).
Chesapeake has acquired a leading Polish label and carton operation in a bid to expand its share of the Central and Eastern European (CEE) market.
Genzyme and Arecor have entered into a collaboration to develop advanced formulations for protein therapeutics.
Archimica has entered into an exclusive distribution agreement with a Merck KGaA subsidiary to provide building blocks and special reagents for organic synthesis.
Rising use of biologics and a tax initiative will drive the streamlining of Indian supply chains, helping companies to deliver drugs at affordable prices, according to PwC.
Next week in-Pharmatechnologist heads for the excitement, energy and razamatazz of New York, US and Interphex 2010.
Sanofi Aventis’ expanded R&D centre in China opened for business last week, further building the French drugmakers presence in the country.
Hikma is to take full control of its Algerian joint venture in an $18.5m (€13.6m) deal, continuing its expansion in the region.
Spain-based Telstar has acquired Usifroid, strengthening its position in France and adding freeze drying technology and expertise.
US delivery specialist Penwest is to apply its Timerx tech to “complex” generic pharmaceuticals in a development and commercialisation pact with non-branded drugmaker Alvogen.
Amcor Flexibles has expanded its drug packaging capacity with the installation of a new blown-film production line at its facility in Mundelein, Illinois, US.
The drug industry will gain new options for sterile contract development and manufacturing in the near future with DPT Laboratories, NextPharma and Vetter each working on new dedicated units.
Winsunny Pharma has exclusively licensed NMT’s HGCP technology, which produces APIs in low micron and nano-sized range, to manufacture a hyperlipidemia-controlling drug in China.
US group Charter Medical says its new-single use culture bags provide a stable environment that enhances cell growth and viability.
German glassmaker Gerresheimer has set up a new sales office in Russia and says growth in country’s drug packaging market is strategically important.
Parexel has implemented a web-based system to help it handle the increase in data volumes that has resulted from the expansion in number, size and complexity of post-approval studies.
US biotechnology company Genentech presents new $400m pharmaceutical manufacturing and distribution facility in Hillsboro, Oregon and says construction is nearly complete.
Boston BioCom has produced HSP-avidin fusion protein for use in a self-assembling vaccines platform as part of collaboration between its Jantibody Therapeutics subsidiary and Pfenex.
in-PharmaTechnologist presents its weekly round up of movements in the pharma sector, including appointments at Genzyme, PharmAthene and Cadence Pharmaceuticals.
The Chinese SFDA has found that four batches of rabies vaccine produced by Jiangsu Yanshen contained insufficient quantities of API and is investigating the conduct of some employees, according to Simcere.
Unilife has initiated a 24/7 manufacturing cycle at its facility at Lewisberry, Pennsylvania, US after it received marketing clearance for its Unitract 1ml insulin syringes from the US FDA.
Vaisala has launched a humidity and temperature probe designed to monitor the processing, packaging and storage environments of pharmaceuticals and biologics.
SAFC has opened the $30m (€22m) expansion of a US production facility, adding HPAPI capacity to meet rising demand for Phase III and commercial manufacturing services.
US firm Isis Pharmaceuticals could earn $1.5bn from its new antisense RNA drug development partnership with UK pharmaceutical major GSK.
Sanofi-Aventis says French manufacturing operations will focus on vaccine and biotech drugs, unveiling €150m ($202m) plan to shift emphasis away from synthetic chemistry-based production.
Hyde Engineering + Consulting has opened an office in Dublin, Ireland, enhancing its ability to provide Europe-based biopharm with compliance, qualification and automation services.
Prosonix says UMAX is “technology of choice” for respiratory API production after successfully scaling-up the particle engineering tech for multiple compounds in GMP quality facilities.
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