Difficulties transferring know-how from US Pharmas to plants in Puerto Rico may be responsible for the high incidence of manufacturing quality problems on the island, according to the authors of a new study.
Contract research organisations (CROs) in Andhra Pradesh, India have set up a forum designed to improve the transparency of clinical research conducted in the region.
Japanese CMO Toyobo says it will increase capacity for injectable drugs to secure its position as a service provider in the expanding biopharmaceutical sector.
Ipca Laboratories has added scale to the Phase II support services offered by recent acquisition Onyx Scientific in a bid to build in the US contract manufacturing sector.
in-Pharmatechnologist.com presents a round-up of the latest regulatory developments, including a guide for GMP newbies from Health Canada, an internationally-flavoured revision of the EMA’s rules on batch certification and the EDQM’s latest thoughts membrane-based...
Baxter International has expanded freeze-drying capacity at its biomanufacturing facility in Halle, Germany citing growing pharmaceutical industry demand for cytotoxic contract manufacturing.
DMV-Fonterra excipients (DFE) will buy Indian manufacturer Brahmar Cellulose Private Limited (BCPL) to strengthen its position in the pharmaceutical excipient market and reduce costs.
German chemical maker Wacker Chemie is ramping up its sales operations in India, with the country’s rapidly expanding pharmaceutical sector being one of its key targets.
Open source clinical trial software company OpenClinica has launched a marketing agreement with Athena Healthcare Consultancy to work within the Chinese market.
Chemicals maker Granules India says it will expand manufacturing capacity for oral solid dose (OSD) APIs and drug intermediates in a bid to better meet the needs of clients.
inVentiv Health says European communications group’s new ‘super agency’ structure will help it to compete in a market dominated by large multi-nationals.
US CRO Charles River Laboratories (CRL) has rejigged its upper management as part of a business realignment that unifies its regional research model and preclinical development businesses.
Biocon’s Indian unit Clinigene International has partnered with US counterpart Spaulding Clinical Research LLC to provide clinical pharmacology services.
Catalent is to buy clinical trial supply assets from Aptuit for $410m (€285m) as it adds scale to handle the shift to preferred provider relationships.
The EMA says current GCP rules make quality management in trials too costly and need to be revised into a code that meets the needs of academics, small and midsized drugmakers and Big Pharmas alike.
Russian authorities need to dedicate more resources to reviewing trial applications ahead of new site accreditation rules due to come into effect later this year according to report on the country’s contract research sector.
International Chemical Investors Group (ICIG) will take over Roche’s Colorado API plant in a bid to gain footing in the peptide manufacturing industry.
The EDQM has suggested Google Earth as a potential source of GPS co-ordinate data for manufacturing sites that must be supplied in CEP applications under recently introduced requirements.