The generic drug industry and the US FDA have reached an agreement that would see the former fund the latter’s overseas facility inspection programme to the tune of $299m a year, according to a number of reports.
International Chemical Investors Group (ICIG) will take over Roche’s Colorado API plant in a bid to gain footing in the peptide manufacturing industry.
India’s CDSCO has issued draft guidance designed to help active pharmaceutical ingredient (API) importers streamline the submission and registration process.
US Government Officials have implored ten major pharmaceutical companies to give up information in the race to solve the 2007-2008 contaminated Chinese herparin incident.
US stem-cell therapy firm NeoStem predicts that output of its China-based generic antibiotics subsidiary Suzhou Erye Pharmaceutical will increase after further manufacturing approval from the SFDA.
Indian CRAMS firm Jubilant Life Sciences has renamed HollisterStier Contract Manufacturing and hired a new BD exec in latest stage of North American reorganisation.
Chemicals supplier Aceto Corp has its sights set on opportunities in the generic drug sector after soaring active pharmaceutical ingredient (API) and intermediates sales helped it to a strong set of quarterly financials.
Carbogen Amcis’s Indian plant has met industrial standards for the containment and handling of highly potent active pharmaceutical ingredients (HPAPI).
US drug developer, PharmStar Pharmaceuticals, has reached an agreement to buy a new 24,000 square foot manufacturing facility in Wilson, North Carolina.
The US Food and Drug Administration (FDA) has issued a new advisory designed to help drugmakers prevent the formation of glass fragments in vials following a spate of recent recalls.
A new study suggests pressurised carbon dioxide can accelerate crystalisation during drug production, and potentially save manufacturers time and money.
Swiss pharmaceutical ingredient maker Helsinn says its new cytotoxic API production plant will be operational for laboratory-scale projects early next year.
Global API service provider, ScinoPharm, is to begin the commercial manufacture of vilazodone hydrochloride, the active pharmaceutical ingredient (API) in Clinical Data Inc.'s new antidepressant, Viibryd.
SurModics is still considering “strategic alternatives” for its pharmaceutical business, which has seen revenues continue to decline in the first quarter of 2011.
The US FDA has suggested pharmaceutical firms use a maximum bead size of 2.0mm for modified-release drugs formulated for “sprinkle” delivery to avoid problems resulting from inadvertent chewing.
US CMO Deltex Pharmaceuticals has been ordered to permanently halt manufacturing operations and recall all drugs it has distributed since October 2008, under a consent decree obtained by the FDA.
Solvent selection and solid loading are critical to optimising the spray drying process and unlocking its solubility-enhancing properties for drug production according to a new report by ISP Pharmaceuticals.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including a departure at the US FDA’s principal deputy commissioner and appointments at Cephalon, AstraZeneca and Biogen Idec.
The European Medicines Agency (EMA) has highlighted the quality APIs manufactured outside the EU as an area of concern in the draft 2015 road map it unveiled this week.
The US FDA has finally become a member of the Pharmaceutical Inspection Convention and Pharmaceutical Co-Operation Inspection Scheme (PIC/S) after a five-year application process.
Johnson & Johnson (J&J) dominated recall and quality control (QC) news over the past year but others also faced issues. in-PharmaTechnologist presents five of our most read QC articles of 2010.
Big pharma continued to cut in 2010, closing plants and laying off staff in an attempt to cut costs and adjust post-merger. in-PharmaTechnologist presents a round up of five of the most read in 2010.
in-PharmaTechnologist presents five of our top audio-visual articles of 2010, including a map of Pfizer’s plant closures, gangsters in the pharma industry and a look inside SAFC’s HPAPI plant.
The Partnership for Safe Medicines (PSM) has established a presence in India to bring together local stakeholders and protect consumers from counterfeit medicines.
Mandatory guidelines for labelling of OTC liquid medication for children should be issued, said researchers who found major inconsistencies in labels and dosage measuring devices.
in-PharmaTechnologist presents its latest round up of movements in the pharma sector, including the departure of an FDA foreign inspections official and the search for a leader of the EMA.
Aoxing Pharma and Johnson Matthey team up to research, develop, manufacture and market active pharmaceutical ingredients (APIs) for narcotics and neurological drugs in China.
The WHO is today initiating a pilot prequalification programme for selected APIs used in drugs for HIV and related diseases, antimalarials and anti-tuberculosis medications.
