30-May-2016 - The US FDA was warned CordenPharma about manufacturing operations at a plant in Italy that was approved to make injectable cancer drugs last year.
26-May-2016 - Xellia Pharmaceuticals has started building a stability and release-testing unit at its API facility in Budapest, Hungary that is designed to support increased output.
26-May-2016 - The US FDA has voted in favour of two combination type 2 diabetes drugs putting Novo Nordisk and Sanofi head-to-head in a crowded market.
25-May-2016 - Selcia has opened a production facility for 14C radiolabelled drug ingredients in the UK citing growing demand from CROs and sponsors running first-in-man studies.
25-May-2016 - The US FDA has issued warning letters to two API makers found to have deviated from cGMP: Germany’s BBT Biotech and China’s Tai Heng Industry.
25-May-2016 - An API plant operated by Dhanuka Laboratories does not comply with good manufacturing practices according to Croatian regulators.
23-May-2016 - Italian API firm Olon SpA has signed a definitive agreement to buy Infa Group in a deal designed to strengthen its portfolio.
23-May-2016 - Indian API maker JP Laboratories is unable to sustain GMP compliance at its facility in Daund, Maharashtra according to the Italian Medicines Agency (IMA).
23-May-2016 - APIs made by Krebs Biochemicals and Industries at its facility in Visakhapatnam, India pose a ‘critical risk’ to public health according to Italian regulators.
18-May-2016 - Suir Pharma is set to close or be sold with the loss of 130 jobs less than a year after it was acquired by Slovakian API manufacturer Saneca Pharmaceuticals.
17-May-2016 - Fermion will invest €30m ($33m) to expand its API facility in Hanko, Finland to build its high potency drug ingredient manufacturing business.
17-May-2016 - Shanghai Fosun Pharmaceutical has confirmed it made a takeover bid for Indian sterile injectable drug firm Gland Pharma.
05-May-2016 - AMRI has acquired the Italy-based chemical company, Euticals, in a move that expands its API development and manufacturing business.
03-May-2016 - Increased use of generics has put pressure on drug reviewers according to the EDQM which has called for more cross border collaboration and harmonization of regulations.
03-May-2016 - Codexis has completed the transfer of its protein engineering platform to a GSK earning it a $7.5m milestone payment.
02-May-2016 - An API facility Cambrex is setting up in Charles City, Iowa will be operational later than planned due to delayed equipment deliveries and installation challenges.
28-Apr-2016 - Indian firm Polydrug Laboratories failed to investigate complaints about APIs containing foreign bodies including hairs and insects, the US FDA says in a Warning Letter.
27-Apr-2016 - WuxI AppTec has a chemical trading network designed to help drug manufacturers source more efficiently.
27-Apr-2016 - AstraZeneca will supply Ironwood Pharmaceuticals with the API and finished dosage form of the gout drug Zurampic under the licensing deal agreed this week.
26-Apr-2016 - The savings will come from centralising manufacturing services and will complement the firm’s cost-saving business division launched last year.
The International Conference of Harmonisation (ICH) guidance document on elemental impurities, Q3D, reached step 4 in December 2014, m...
Over the years, multiple active pharmaceutical ingredients (API) have been successfully combined into single dosage forms primarily th...