19-Jan-2017 - The implementation of serialisation regulations in 2017 are among the opportunities for drugmakers to improve manufacturing efficiencies, says IT and engineering firm Zenith Technologies.
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 - Suzhou Pharmaceutical Technology faked quality documents, shipped a banned supplier's API to the US and failed to store materials properly according to the US FDA.
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developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.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 - The US FDA has finalised its guidelines on cGMP and quality system compliance for drug and delivery device combination products.
11-Jan-2017 - Aerie Pharmaceuticals Inc will lease a 30,000 sq ft manufacturing facility in Ireland to commercialise its eye-drop product for Glaucoma after delays at a third party CMO.
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.
09-Jan-2017 - Drugmakers must include a transaction identification number when buying or selling machinery for tabletting or encapsulating controlled substances, according to a final ruling from the US DEA.
05-Jan-2017 - Recipharm receives approval to buy Kemwell’s Indian operations and PolyPeptides completes the acquisition of Lonza’s peptide business. Welcome to in-Pharmatechnologist’s 2017 M&A round-up.
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.
20-Dec-2016 - US FDA inspectors have raised questions about an API manufacturing facility in India that is operated by Granules India and Ajinomoto OmniChem.
Choosing and implementing your environmental monitoring instruments is critical for a safe production & continued compliance. Ensu...