13-Jul-2015 - Fresenius Kabi and a UK drug manufacturer have been sentenced for supplying faulty insulin syringes which contributed to a diabetic man’s death.
09-Jul-2015 - Mylan is expanding its recall of injectable Gemcitabine and Methotrexate batches after finding visible particulates.
09-Jul-2015 - A new final rule from the US FDA now requires all drug and biologic manufacturers to notify the agency electronically of a permanent discontinuance or an interruption in manufacturing six months in advance, or as soon as is practical, before the disruption causes a shortage.
07-Jul-2015 - The European Commission last week officially added Israel and Brazil to a list of countries outside the EU that have standards of manufacture and supervision of APIs equivalent to those of the EU.
07-Jul-2015 - The EU has launched a €5m ($5.5m) programme across six facilities for characterising European nanomedicines.
06-Jul-2015 - Toronto-based Attix Pharmaceuticals has received a US FDA warning letter after an inspection from November and a lack of corrective actions in the company’s response to the FDA.
02-Jul-2015 - Hospira has begun commercial production at a sterile injectable plant in India hit with several 483 forms after the US FDA deemed the site ‘acceptable.’
30-Jun-2015 - In response to a flood of requests over uncertainties regarding ICH Q7 guidance, the international consortium recently released a question and answer (Q&A) document intended help companies implement appropriate GMPs (good manufacturing practices) at all stages of the API supply chain.
29-Jun-2015 - Canada has asked importers to quarantine APIs made by India’s Polydrug Laboratories over concerns about its manufacturing plant in Ambarnath in Maharashtra.
23-Jun-2015 - China is set to become a major vaccines manufacturer for emerging markets once it untangles some regulatory quirks, says a panel at BIO 2015.
17-Jun-2015 - Polydrug Laboratories chose not to log customer complaints about APIs made at its plants in Maharashtra according to Slovenian regulators.
16-Jun-2015 - Health Canada has issued Hospira with an import ban over concerns about a testing lab at its manufacturing facility in Liscate, Italy.
12-Jun-2015 - A Jubilant HollisterStier sterile manufacturing facility hit with a warning letter in 2013 has been upgraded following inspections by the US FDA last year.
09-Jun-2015 - A capsule inspired by the porous structure of seashells has been developed to protect drugs from extreme temperatures and could be used in controlled delivery.
08-Jun-2015 - Despite increased scrutiny from regulators, one third of Indian pharma manufacturers and CMOs have yet to conduct a review to assess potential gaps in the assurance of data integrity, according to a new EY survey.
03-Jun-2015 - Multinational excipient-makers will drive US interest in EXCiPACT, the industry-led certification scheme says as a UK Colorcon plant becomes the eighteenth site to receive accreditation.
03-Jun-2015 - The US FDA has issued guidance to manufacturers on impurities in finished drugs which can change human DNA and cause cancer.
03-Jun-2015 - The US FDA has issued a warning letter to Czech API manufacturer VUAB Pharma for failing to properly respond to microbiological contamination and data integrity issues.
27-May-2015 - Lonza shipped a sample batch of a drug for resistant cancers this week and is set produce commercial supplies if the Phase I candidate goes on to be approved says Sunshine Biopharma.
26-May-2015 - Intertek has opened a new stability facility citing demand for bespoke drug and device services like abuse potential assessments and stress testing.
This method describes near-infrared spectroscopy in diffuse reflection for determining residual moisture in a lyophilized pharmaceutic...