CMOs (contract manufacturing organizations) developing pharmaceutical intermediates have shifted their focus to complex nucleosides, peptides and carbohydrates over the last five years, an expert says.
‘Long awaited’ draft guidelines on excipient risk assessments proposed by the European Commission (EC) have been welcomed by industry group IPEC Europe.
Dow has contracted Cambrex to make its solubility enhancing polymer HPMCAS, adding manufacturing clout to its bioavailability-focused collaboration with Bend Research.
Drug Master File (DMF) completeness reviews required under GDUFA could take three months and should be sought before ANDA submission according to the US Food and Drug Administration (FDA).
in-Pharmatechnologist.com presents a roundup of news in the fine chemicals sector, beginning with Johnson Matthey which has started a review of its active pharmaceutical ingredient (API) business after competition in the UK impacted its third quarter...
Mitsubishi Chemical Holdings (MCHC) has announced plans to buy the ‘dominant’ pharma-grade HPMC capsule maker Qualicaps as the global gelatin shortage continues.
Representatives from Pfizer, J&J, Dow Corning and EMD Millipore will join IPEC Americas’ executive board and lead the excipient industry organisation as it moves to a new HQ.
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.
Euticals Limited has halted API production at its Welsh site after local authorities found it was housing “substantial” quantities of a potentially explosive chemical.
Domestic regulatory efforts to improve ingredient quality will increase costs but Indian industry will remain competitive, according to the Secretary of Commerce.
An industry consortium has asked the USP to delay new elemental impurities chapters on concerns that lack of harmonization with ICH Q3D will create compliance difficulties, shortages and additional costs.
Arkema has restructured its business as part of its bid to generate €8bn ($10.3bn) in 2015 and become a world leader in the specialty chemicals sector.
A new non-glycosolated protein production method using E.coli can cut manufacturing costs by up to 50 per cent as well as speeding up the process, according to researchers at the University of Arkansas.
Brazilian regulator Anvisa has extended the deadline for public comment on plans to require excipient manufacturers to be GMP compliant after a month of industrial action by government workers.
US biosecurity experts are calling on industry and the Government to “get a handle” on the supply chain for drugs used in times of pandemic or bio attack.
A new formulation of Genetech’s breast cancer drug Herceptin means patients could soon receive treatment via injection, rather than time consuming intravenous drip.
Scientists at UCF (University of Central Florida) believe they have found a simpler and more efficient way to mass produce the structured nanoparticles used for drug delivery and production.
Biopharma manufacturers are putting their supply chains at risk by failing to prepare for emergencies, according to a new study by Best Practices, LLC.
Results season is well under way and in-PharmaTechnologist.com is here to bring you the latest as companies announce their chops, changes and plans for the coming quarters.