19-Jan-2017 - Czech authorities have ordered B. Braun Medical s.r.o to stop supplying medicines from a warehouse in Rudná after identifying breaches of good distribution practice (GDP) guidelines.
18-Jan-2017 - The US FDA is inspecting more foreign plants but has not shown if its efforts have improved the quality of API and drug imports according to a GAO report.
18-Jan-2017 - The US FDA has criticised Sato Yakuhin Kogyo Co responses to data integrity concerns an inspection team raised after visiting its drug plan last June.
17-Jan-2017 - Problems at a CMO have forced Janssen-Cilag to ship Haldol made in Austria to patients in Switzerland to maintain supplies.
17-Jan-2017 - The US FDA expects biosimilar developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.
16-Jan-2017 - The CDSCO has urged pharmacies to stop selling prescription antibiotics over-the-counter in an effort to slow the spread of antimicrobial resistance.
16-Jan-2017 - Industry groups have reiterated calls for UK drug approval and safety laws to be kept in line with EU rules, arguing that consistency benefits governments and patients Europe-wide.
12-Jan-2017 - President elect Donald Trump has said he will bring drug manufacturing back to the US and introduce bidding measures to cut the amount the country spends on medicines.
12-Jan-2017 - Welcome to in-PharmaTechnologist's monthly round up of who's been moving where in the small-molecule manufacturing world. The CEO of BMS is moving internally, Axim Biotechnologies and Pharmalink have new board members, whilst Vium and Dova Pharmaceuticals have new Chief executives.
12-Jan-2017 - The US FDA has finalised its guidelines on cGMP and quality system compliance for drug and delivery device combination products.
10-Jan-2017 - President-elect Donald Trump has asked noted vaccine skeptic Robert F. Kennedy Jr. to chair a commission to investigate vaccine safety.
10-Jan-2017 - If you're not going to San Francisco, in-Pharmatechnologist brings you a smattering of the best tweets from the 35th Annual JP Morgan Healthcare Conference.
09-Jan-2017 - Danish regulators have banned Europharma DK ApS from making or importing medicines and drug intermediates after identifying serious breaches of GMP at its plant in Esbjerg.
04-Jan-2017 - A Wockhardt facility in India put under import alert last year has received a US FDA warning letter citing issues ranging from data discrepancies to inappropriate aseptic clothing.
04-Jan-2017 - Late last week, a fire at Sun Pharmaceutical Industries Limited’s Ahmednagar factory, which manufactures APIs, sent four employees to the hospital.
22-Dec-2016 - The EMA has started reviewing drugs tested by Micro Therapeutic Research Labs after an inspection by Dutch and Austrian regulators identified potential data integrity problems.
20-Dec-2016 - Spanish regulators have found problems at a facility operated by immunotherapy producer Laboratorio Angulema.
13-Dec-2016 - The US FDA has given Akorn Pharmaceuticals' facility in Decatur, Illinois a clean bill of health after a re-inspection last week.
13-Dec-2016 - Natco Pharma and partner Alvogen have launched the “first generic equivalent” of Roche’s Tamiflu (oseltamivir phosphate) in the US.
12-Dec-2016 - Catalent has become the first CDMO to join the PSCI – a voluntary industry initiative focused on the social, environmental and economic impact of the supply chain.
09-Dec-2016 - The WHO has agreed to source drugs from manufacturers which use sustainable production methods.
08-Dec-2016 - AmerisourceBergan has warned of the dangers of reimportation a day after the Senate rejected Bernie Sanders’ “Trump proposal” to overturn the ban.
07-Dec-2016 - The US FDA has issued Sun Pharmaceutical Industries with a Form 483 citing problems identified at its plant in Halol.
07-Dec-2016 - Mylan NV has announced a restructuring plan that it says will impact less than 10% of its workforce.
06-Dec-2016 - Fake erectile dysfunction drugs found in Serbian coaches entering Switzerland were made in India according to regulator Swissmedic.