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Pharma/Fine Chemicals Roundup – July 5
7:26 AM MDT | July 5, 2011 | By DEEPTI RAMESH
USP PUBLISHES STANDARDS FOR TESTING OF MEDICINES AND INGREDIENTS
The United States Pharmacopeial Convention (USP; Rockville, MD) has announced the availability of a free, online collection of voluntary public standards to allow testing of a medicine and its ingredients. These standards appear in the new USP Medicines Compendium (MC) and are available at www.usp-mc.org. The MC will support good quality medicines through tests, procedures and acceptance criteria for critical quality attributes, and it will include standards for medicines legally marketed in various countries, USP says. MC standards are voluntary, unless they are adopted by a regulatory authority.
“Public standards help ensure that all manufacturers of a given medicine or ingredient meet the same fundamental requirements, providing a common ground that allows practitioners to have confidence in the medicines they prescribe, and patients in the medicines they take. These standards are critical—especially where regulatory resources are constrained or absent,” says Roger L. Williams, CEO of USP. “The USP Medicines Compendium will be offered freely to all, so that it can be used by anyone—not just manufacturers, but purchasers, regulatory agencies and other pharmacopeias as well, as a means of helping to ensure high-quality medicines. As the only nongovernmental pharmacopeia in the world, USP is in a special position to develop this compendium.”
Based on public comment, USP expects the standards to become authorized and final later in 2011, following approval by an expert committee of the USP Council of Experts.
EQUATEQ SIGNS API DEAL WITH AMARIN; TO EXPAND FACILITY
Equateq (Isle of Lewis, Scotland), a privately-owned lipid production company, says it has signed a long-term supply agreement with biopharmaceutical company Amarin Corp. (Mystic, CT), under which Equateq will, on commercialization, sell up to $20 million/year of API for use in AMR101, an omega oil pharmaceutical under development at Amarin, for cardiovascular indications.
“This is our most significant agreement to date, and we look forward to applying our Maxomega technology to deliver bulk API concentrate to Amarin,” says Adam Kelliher, CEO of Equateq. “The opportunity presented by Amarin is potentially immense, and we aim to ensure they have supply chain security to meet anticipated significant demand.”
Equateq says it will now begin phased capacity expansion plans aimed at creating sufficient capacity to meet the demand. The expansion will take place at Equateq’s facility at the Isle of Lewis, where Equateq already manufactures lipid APIs.
LONZA RAISES WORKING HOURS AT VISP TO SECURE SITE'S FUTURE
By Natasha Alperowicz
Lonza says it will increase the weekly working hours for all employees at its Visp, Switzerland manufacturing site, starting tomorrow and continuing until the end of 2012, to improve the site’s profitability. The weekly working hours will increase from an average of 41 to 43 hours. The site employs about 2,900 people, accounting for more than one-third of Lonza's global workforce. Lonza, during the next 18 months, plans to raise the site’s productivity, optimize its integration and product portfolio, and expand its technology offering as well as introduce new product platforms and services.
The company says that profitability of the Visp manufacturing site has declined due to “the massive strength of the Swiss franc, an aggressive pricing policy of competitors and increasing raw material and energy costs.” The company expects a negative currency effect of about SF60 million-SF70 million ($71.9 million-$83.9 million) in 2011, which strongly impacts Visp, its main manufacturing location. This pressure is expected to continue in the short and medium term, the company says.
“We have a high utilization and the plants are working at full capacity, but our profitability is troubled due to the negative exchange rate which increasingly diminishes revenue”, says Stephane Mischler, site manager at Visp. He expressed confidence that Visp employees will support the temporary working hour increase to secure the future of the site. The company hopes that these measures will help sustain high plant capacity utilization without additional staff.
STRIDES ARCOLAB TO BUILD BIOPHARMACEUTICAL FACILITY IN MALAYSIA
Pharmaceutical company Strides Arcolab (Bangalore, India) says its subsidiary Agila Specialties Malaysia has signed an agreement with Malaysian Bio-XCell for the establishment of a facility to manufacture biopharmaceuticals and sterile injectables in the Bio-XCell ecosystem at Nusajaya, in the state of Johor, Malaysia. Bio-XCell is a biotechnology park for industrial and healthcare biotechnology, with a focus on manufacturing and R&D. The park is slated to be the new regional biotech hub of Asia, Strides Arcolab says.
The project will be built by Bio-XCell to the design requirements of Strides Arcolab and will be leased out to Strides Arcolab s on a long-term basis. In the light of Agila’s partnerships with global pharmaceutical corporations the establishment of a facility in Bio-XCell represents a strategic move to further bolster Agila’s manufacturing presence in the region, Strides Arcolab says. Malaysia provides the company with a strategic location to expand its manufacturing operations, and the attractive financial incentives by the Malaysian government and the presence of a pharma/biotech ecosystem were the reasons for the decision to establish this facility, Strides Arcolab says.