The US FDA’s Puerto Rico office may be “having difficulty” monitoring drug manufacturing in the country according to the Congressional Committee on Oversight and Government Reform.
Adding Indian cGMP HPAPI capabilities builds on Arch’s strategy of differentiating through technology and establishes it in an emerging and profitable sector.
ATMI has acquired Artelis, a Belgian biotech firm, in an effort to “get closer to customers” by widening its disposable technology portfolio to the life sciences research and manufacturing sector.
RecipharmCobra Biologics has called for more R&D tax breaks in Europe after French Ministry of Higher Education and Research recognises it as key provider.
Overseas offices will help the FDA schedule inspections more quickly in times of crisis but, as yet, employees based abroad have visited relatively few facilities.
Overseas FDA offices have realised immediate benefits but strategic planning is needed to ensure the ventures, critical aspects of the agency’s ability to ensure drug quality, are long-term successes according to the GAO.
Lonza is seeing increased capacity utilisation and project pipelines in custom manufacturing but warned more stringent regulatory approval is creating volatility.
The United States Pharmacopeial Convention (USP) and six government drug control laboratories in the Middle East and Northern Africa (MENA) join to launch a drug quality improvement Network.
A developmental purification system for Antibody-Drug-Conjugates will be launched by ADC Biotechnology (ADBC), a spin off from Reaxa, which promises reduced manufacturing costs for “magic bullet” cancer drugs.
The WHO is today initiating a pilot prequalification programme for selected APIs used in drugs for HIV and related diseases, antimalarials and anti-tuberculosis medications.
The CDMO Althea Technologies has extended its pre-filled syringe manufacturing capabilities with a new INOVA H3-5 high speed syringe filling line, which will be available for production in Q1 2011.
Cell Biosciences plans to gain ground in the protein-based drugs market by acquiring Convergent Bioscience at the end of October for a cash sum of $12m (€8.6m.)
Prosonix expects high demand for innovative particle processing technologies in the $24bn (€17bn) a-year respiratory pharmaceuticals market over the next few years.
IDT Biologika.says demand for vaccines in emerging markets is big chance for Big Pharma and hence a growing niche for contractors with the technical capabilities to carry out such work.
The FDA is to collaborate with the WHO to build a global surveillance and monitoring system for combating falsified medicines and breaches of the supply chain.
“Musty smells” associated with three Lipitor bottles indicate a problem within the supply chain, says Rexam of Las Piedras, Puerto Rico, who were confirmed by Pfizer as the “third-party recalling supplier.”
Pharmatek Laboratories has once again expanded service offerings at its San Diego, California facility by adding two roller compactors to its solid oral dosage form manufacturing capabilities.
Almac invests $4m in biocatalysis R&D, describing such technologies as the way forward for the cost efficient production of highly chiral APIs and intermediates.
Guy Villax, board member of the EFCG, talks falsified APIs, EU efforts to tackle the issue, and the presence of gangsters in the pharma industry in an in-PharmaTechnologist video interview.
BioNano Consulting (BNC) predicts impending patent loss will accelerate adoption of nanotechnology in drug formulation and head to US to boost US business.
China leads the field in 'potential future' API suppliers, positioning it to become a dominant force as these companies develop, Thomson Reuters said at CPhI 2010.
Gilead Sciences has received a warning letter from the US Food and Drug Administration (FDA) concerning manufacturing problems at the San Dimas, California, plant, where HIV medicines are made.
Xcelience is shortening scale-up time from development to GMP production of clinical trial materials through the installation of dry granulation technology.
RTS Life Science has formed a Pharmaceutical Testing Group to integrate UK developed products for inhaler and tablet testing with US developed products for dissolution and content uniformity testing.
