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.
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.
Indian API maker JP Laboratories is unable to sustain GMP compliance at its facility in Daund, Maharashtra according to the Italian Medicines Agency (IMA).
APIs made by Krebs Biochemicals and Industries at its facility in Visakhapatnam, India pose a ‘critical risk’ to public health according to Italian regulators.
Ajinomoto Althea has been granted a US patent for a whole antibody crystallization method that is faster at producing stable, biologically-active crystals than current techniques.
As “one of the fastest growing areas in pharma,” the demand for finished dosage formulations is having an impact on several aspects of the CMO industries.
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.
Envirotainer has opened a ‘service station’ in Delhi, India to help local API and generic drug manufacturers comply with international shipping regulations.
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.
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.
AstraZeneca will supply Ironwood Pharmaceuticals with the API and finished dosage form of the gout drug Zurampic under the licensing deal agreed this week.
The WHO has removed two APIs supplied by Anuh Pharma from its list of prequalified ingredients and announced plans to inspect the firm’s facility in Boisar, India.
API manufacturer PCI Synthesis has set up a polymer development group citing growing drug industry demand for advanced coating technologies and excipient technologies.
A European chemical industry group has reiterated that gelatin is safe after Indian regulators called for feedback on a plan to replace the excipient with cellulose in pharmaceutical capsules.
Pharmachem Technologies has started expanding its API facility in Grand Bahama just days after its main customer Gilead Sciences won US FDA approval for a new HIV drug.
Closure of its Benicar intermediates plant was prompted by impending US patent loss and a decision to focus on large molecule drugs says Daiichi Sankyo.
Aesica has doubled early formulation development capacity and added controlled drug handling capabilities at its manufacturing facility in Queenborough, UK.
Dipexium Pharmaceuticals has successfully scaled-up API for its antimicrobial peptide phase III candidate Locilex, made from the skin of the African Clawed Frog.
Drug companies were a more important source of revenue for Lonza in 2015 than in previous years with four of its five biggest spending customers coming from the pharmaceutical sector.
Compounds that leave pathogenic bacteria alive but harmless could yield antibiotics that are less likely to induce resistance development say the authors of a new study.
Pfizer has said it will invest $21m to expand a plant in Adelaide, Australia which will manufacture a candidate biosimilar version of Amgen’s white blood cell booster, Neulasta.
Pollution from antibiotic plants a hot topic at DCAT week
API makers that don’t treat wastewater to cut costs and keep prices low are spreading antibiotic resistance says DSM-Sinochem, which wants drug companies to stop buying from firms that “distort” the market.
The process of sorting out problems with the US FDA's controversial Inactive Ingredients Database (IID) is shaping up to be a huge task, particularly as the agency is working through a backlog of missing updates extending back several years.
Selling most of its API business had only a limited impact on revenues in 2015 according to BASF, which has reiterated its plan to retain its ibuprofen, PEG and omega-3 operations.
French regulators have raised concerns about heparin made by Chinese supplier Dongying Tiandong Pharmaceutical and called on the EMA to revoke its GMP certificate.
