01-Sep-2014 - The US FDA has criticised the Compounding Shop and Zion Rx Formulations Services for making unapproved and contaminated drugs.
01-Sep-2014 - The US FDA import ban imposed on Apotex in 2009 was legal and the firm was not treated more harshly than generics rival Teva according to a State Department arbitration panel.
28-Aug-2014 - Dr Reddy’s Laboratories says accusations by the US Government’s Consumer Product Safety Commission (CPSC) that it violated childproof packaging rules could cause significant losses for the company.
26-Aug-2014 - Drug quality and standards organisation USP has joined a campaign to raise awareness about the risks posed by illegal online pharmacies.
25-Aug-2014 - Argentina decided to allow Indian drug imports after inspecting just five of the country's 793 manufacturing facilities according to documents released this week.
21-Aug-2014 - Indian manufacturer Claris Lifesciences has had its injectable drug manufacturing facility in Ahmedabad approved by the UK MHRA.
21-Aug-2014 - Ben Venue Laboratories will remain inactive says new owner Hikma as it looks to optimise its injectables manufacturing network.
21-Aug-2014 - Opiate API manufacturer Macfarlan Smith has been fined £12,000 for failing to ensure the safety of an employee injured at its plant in Scotland in 2011.
20-Aug-2014 - EU law changes mean all UK firms handling pharmaceuticals for export outside the EEA must now be inspected and pay license fees according to the MHRA.
20-Aug-2014 - Indian drugmaker Amanta has received a warning letter after the US FDA found evidence of data falsification and unsanitary conditions – including dead and decaying frogs next to a product exit dock – during an inspection last year.
19-Aug-2014 - WuXiPharmaTech has received US FDA approval to manufacture an API for a commercial drug from a plant in Shanghai.
19-Aug-2014 - Novo Nordisk wants “a political debate” and changes to financial disclosure laws after Danish authorities fined it $90,000 for not immediately telling investors the US FDA had rejected Tresiba and Ryzodeg in 2013.
18-Aug-2014 - US authorities are reviewing a Neolpharma request for tax breaks for APIs imported to a former Pfizer-owned plant it operates in Puerto Rico.
14-Aug-2014 - GMP failures at an aseptic plant owned by SCM Pharma are part of a wider industry trend affecting several sterile sites in the UK, according to the ex-owner of the CDMO.
14-Aug-2014 - Ranbaxy has reported a 14% drop year-on-year of overseas revenues attributed in part to the voluntary suspension of shipments from its Toansa and Dewas facilities API facilities.
13-Aug-2014 - The ICH is looking for a new manager for its MedDRA international regulatory terminology standards system to replace current contractor, aerospace and defence technology giant Northrop Grumman.
12-Aug-2014 - Efficacy and safety data from use of unapproved Ebola virus treatments should be shared according to an expert panel convened by the World Health Organisation (WHO) this week.
12-Aug-2014 - GSK has stopped using an ethanol storage tank at a US R&D facility and agreed to pay a fine to settle US Environmental Protection Agency (EPA) allegations that it broke waste management laws.
07-Aug-2014 - In order to ensure uniformity on the state and federal levels, India’s CDSCO (Central Drugs Standard Control Organization) has released seven procedural criteria for state drug inspectors to abide by.
06-Aug-2014 - The Center for Lawful Access and Abuse Deterrence (CLAAD) is working with the US Food and Drug Administration (FDA) on legislation for abuse-deterrent technology in opioids, its directors tell in-PharmaTechnologist.com.