Last week, BASF officially opened a pharmaceutical grade omega-3 active pharmaceutical ingredient (API) facility on the Isle of Lewis, Scotland that it gained with the acquisition of Equateq earlier this year.
Collaborations and expansions dominate Outsourcing-pharma.com’s roundup of developments in the CRO space, with news from Cenduit, Perceptive Informatics, INC Reseach and Spaulding Clinical Research.
Harlan Laboratories has followed 2011 cutbacks and consolidation measures with plans to invest and expand its preclinical services site in Itingen, Switzerland.
The MHRA says as many as 1,200 active pharmaceutical ingredient (API) manufacturing plants may need to be inspected to secure UK supply chains when new EU import laws come into effect next year.
Drugmaker Pfizer is on the list of 74 firms that have not paid their share of the $50m ‘backlog’ fee required under the Generic Drug User Fee Amendments (GDUFA) law.
The US CDER wants drugmakers to find alternatives to two common plasticisers used in tablet coating after studies link them to developmental and reproductive defects in animals.
UK CMO Aesica Pharmaceutical says that working with academia to access cutting edge technologies is critical for contractors that want to meet the demands of the modern drug industry.
Chemi Pharmaceutical CEO says sabotage by former employee behind accusations of falsified test results that prompted Canadian regulators to suspend license.
Researchers say cluster randomized trials (CRTs) present "distinct ethical challenges" and have created 15 "guidelines" to help researchers and ethics committees address them.
Swedish CRO Trial Form Support International (TFS) has bought Italian counterpart Dimensione Ricerca to strengthen its presence in Southern Europe and key therapeutic areas like oncology.
The GDUFA ‘self-identification’ requirement for generic API plants is not a flawed idea says SOCMA’s BDTF after FDA extends registration deadline citing fewer than expected registrations.
GE Healthcare says new cell science lab in Wales will save drugmakers time and money and create more accurate alternatives to animal-based drug toxicity testing models.
Positron emission tomography (PET) drug manufacturers have three years to gain NDA or ANDA approval or they must remove their products from the market according to the US FDA.
India's national Atomic Energy Regulation Board (AERB) has approved GVK Biosciences to perform certain isotope-labeling research in its facility, according to the Hyderabad-based contract research organization (CRO).
The group whose comments on sponsor oversight drew criticism from ACRO says the industry group's preferred ‘trust and verify’ model only works if verification efforts are robust.
Ranbaxy has predicted ‘market disruption’ after quality problems forced it to halt production of its generic version of Pfizer’s cholesterol buster Lipitor.
in-PharmaTechnologist.com presents its latest round-up of movers and shakers in the world of pharmaceuticals, including news from Cipla, Dr. Reddy’s and Immunogen.
The bioavailability market lacks a leader that can offer comprehensive solutions according to Merck Millipore, which has set its sights on filling the gap through investments and a new lab.
The USP has delayed new elemental impurities standards but is still confident they can be harmonized with ICH Q3D even if May 2014 implementation target is kept.
Euticals Limited has halted API production at its Welsh site after local authorities found it was housing “substantial” quantities of a potentially explosive chemical.
