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Compounding the problem: US warns two more pharmacies

01-Sep-2014 - The US FDA has criticised the Compounding Shop and Zion Rx Formulations Services for making unapproved and contaminated drugs.

US FDA 2009 import ban legal NAFTA panel tells Apotex

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.

US claims Dr Reddy’s broke safety packaging rules for 4 years

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.

USP joins campaign against illegal online pharmacies

26-Aug-2014 - Drug quality and standards organisation USP has joined a campaign to raise awareness about the risks posed by illegal online pharmacies.

Argentina to allow Indian drug imports after inspecting five plants

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.

Claris gets MHRA OK for injectables plant

21-Aug-2014 - Indian manufacturer Claris Lifesciences has had its injectable drug manufacturing facility in Ahmedabad approved by the UK MHRA.

Ben Venue site has no place in injectables network, says new owner Hikma

21-Aug-2014 - Ben Venue Laboratories will remain inactive says new owner Hikma as it looks to optimise its injectables manufacturing network.

Macfarlan Smith fined $12,000 after accident at API plant

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.

UK drug exporters shipping outside the EEA must seek MHRA approval

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.

Frogs, fungus and falsified data - Indian firm falls foul of US FDA

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.

US FDA 'stamp of approval' testament to WuXi's growth in APIs

19-Aug-2014 - WuXiPharmaTech has received US FDA approval to manufacture an API for a commercial drug from a plant in Shanghai.

Novo Nordisk defiant despite $90,000 disclosure fine

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.

US mulls Federal Trade Zone status for Neolpharma Puerto Rico plant

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.

SCM's woes part of UK-wide aseptic slowdown, says ex-owner

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.

API sales down 81% as Ranbaxy feels fallout from US import alerts

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.

ICH seeks bids to replace Northrop Grumman as MedDRA contractor

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.

WHO: Data from use of unapproved Ebola drugs should be shared

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.

GSK settles with US EPA over waste storage at US R&D site

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. 

India’s CDSCO outlines procedures for state inspections of manufacturers

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.

Anti-addiction formulation rules on the way says drug abuse non-profit

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.

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