Australia’s Therapeutic Goods Administration will reclassify all codeine products to ‘prescription only’ from February 1, in a bid to combat opioid tolerance, dependence and poisoning.
Eurodis says Brexit-related costs and admin burden placed on UK pharma may affect availability of drugs for rare diseases and discourage development of such products.
Chinese patients’ concerns about the quality of locally made drugs are an opportunity for US manufacturers to increase market share according to the US-China Economic and Security Review Commission.
UK regulators have banned Apotex Research Private Limited from shipping drugs made at its plant in Bangalore, India to the EU after inspectors raised concerns about the potential for cross contamination.
Identifying dangerous medicines will take months longer if the UK cannot negotiate continued involvement in EU drug safety and health monitoring say industry groups.
UK regulators have issued Bangladesh-based drug maker The Acme Laboratories Limited a statement of GMP non-compliance after finding a plant inspection.
The US FDA has issued Establishment Inspection Reports (EIRs) closing out inspections at Biocon’s biomanufacturing plant in Bangalore and a Divi’s Lab facility in Visakhapatnam.
The International Pharmaceutical Excipient Council (IPEC) has updated its Quality Agreement guidelines to reflect changing regulatory expectations and global nature of supply chains.
The Danish Medicines Agency (DKMA) has banned Europharma from performing manufacturing activities citing a general lack of will and ability to adhere to GMP.
Guangdong Zhanjiang Jimin Pharmaceutical Co. has received a warning letter from the US FDA citing cGMP violations as well as unapproved new drug and misbranding charges.
Pfizer has attributed a 12% operational decline from its sterile injectable products on “capacity constraints and technical issues” stemming from former Hospira facilities.
The US FDA says the recognition of facility inspections from eight European regulatory authorities is an “unprecedented and significant step forward” in the transatlantic Mutual Recognition Agreement.
Fleming Laboratories has been banned from shipping APIs to the US by the FDA which says its manufacturing plant in Nawabpet, Telangana in India is not up to code.
US FDA inspectors have raised concerns about Akorn Inc’s manufacturing facility on Grand Avenue in Decatur, Illinois in a Form 483 made public this month.
Evertogen Life Sciences Limited should recall drugs made at its facility in Mahabubnagar, India according to the MHRA, which identified critical quality and data integrity problems during an audit in August.
Recipharm has installed serialization technology at its contract production facility in Lisbon, Portugal citing impending US and EU rules as a driver for the investment.
Back-up generators and secondary manufacturing sites limited the supply and financial impact of Hurricane Maria across J&J’s Puerto Rican pharma facilities, the firm says.
The European Medicines Agency (EMA) has announced it will launch an updated version of information system EudraVigilance to better monitor suspected adverse reactions to medicines.
The EDQM and Anvisa have signed an agreement that may allow drug firms seeking clearance to sell products in Brazil to file CEPs in approval applications.
Merck KGaA will install a new aseptic filling line at its facility in Bari, Italy for multiple sclerosis drugs, fertility treatments and growth hormones.
AmerisourceBergen (ABSG) has pleaded guilty to distributing misbranded injectable cancer drugs processed at an unregistered facility in Alabama and agreed to pay $260m (€220m).
Aurobindo Pharma Limited has received a Form 483 detailing two problems identified by US FDA inspectors who visited its Unit VI facility in in Chitkul Village, Andhra Pradesh, India.
Biocon says its insulin plant in Malaysia has been awarded a European GMP certificate after an inspection by Ireland’s Health Products Regulatory Authority (HPRA).
A new formulation of Euthyrox linked to a surge in adverse event reports in France is safe, effective and more consistent than the older version of the drug say ANSM and Merck.
Cadila Healthcare says its formulation plant in Moraiya, Gujarat has passed a US Food and Drug Administration (FDA) inspection with no Form483 observations.
Centurion Labs has recalled two lots of cold and allergy meds after the US FDA warned they may have been made at a Pharmatech LLC plant linked to a Burkholderia cepacia outbreak.