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‘James bond’-like tech is the end to overdoses, says formulation firm

03-Sep-2014 - Canadian drugmaker Intellipharmaceutics has developed a kill-switch formulation it says will prevent drug misuse and accidental overdoses.

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.

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.

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.

India changes course, calls for bar codes for mono cartons in April

20-Aug-2014 - Nearly a month after India pushed back its deadline indefinitely  for exporters to put bar codes on their primary packages, the Directorate General of Foreign Trade  (DGFT) has set a new deadline of April 2015.

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.

Manufacturing issues cause recalls for Amgen, Baxter and Caraco

18-Aug-2014 - All three of the manufacturers announced recalls late last week either for potential contamination or cGMP (current good manufacturing practice) deviations.

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.

Sanofi begins distribution of semi-synthetic antimalarials in Africa

14-Aug-2014 - Over the next few months Sanofi and non-profit PATH are delivering the first large-scale batches of an artemisinin-based combination therapy to five African countries, which will for the first time be manufactured with semi-synthetic artesunate.

Merck Millipore invests €12m in French facility

13-Aug-2014 - Merck Millipore, the life science division of Merck KGaA, will invest €12m ($16m) at its Molsheim, France facility to expand its ready-to-use media manufacturing capabilities and capacity.

CMO issues persist as Cubist announces third recall for potential glass in antibiotic

11-Aug-2014 - For the third time since last August, Cubist Pharmaceuticals has recalled lots of its antibiotic Cubicin injection due to the potential of glass particulates in a manufacturing line produced by an unnamed CMO (contract manufacturing organization).

EMA concept paper focuses on quality control with animal tests

05-Aug-2014 - The European Medicines Agency (EMA) has issued a concept paper  on transferring quality control methods validated in collaborative trials that is intended to encourage the uptake of better tests in terms of the replacement, reduction and refinement of the use of animals in tests.

Fresenius: US supply from troubled Indian plant to restart in Q3

05-Aug-2014 - Fresenius Kabi has recommenced production at a troubled Indian facility and expects to start shipping APIs to the US in the next few weeks.

China's GMP drive will reduce API competition, says ScinoPharm

04-Aug-2014 - China has tightened its GMP requirements and compliant API suppliers will benefit from a reduction in competition, according to ScinoPharm.

Hospira's Rocky Mount 'returns to health' as reinspection cites no observations

31-Jul-2014 - Hospira has reached “a major milestone” in its remediation efforts at its troubled Rocky Mount plant following a US FDA inspection which resulted in zero observations.

Impax preparing response to FDA Form 483 with 10 observations

30-Jul-2014 - Impax Laboratories said it is working to address issues raised in an FDA Form 483 for its Taiwanese manufacturing facility, which was cited with 10 observations following an inspection in late July.

Chinese firm imported misbranded API into US, says FDA warning letter

30-Jul-2014 - Zhejiang Jiuzhou Pharmaceutical has received an FDA warning letter after shipping a misbranded active pharmaceutical ingredient to the US.

Biocon: Political turmoil hits sales, but quality systems ensure future

29-Jul-2014 - Robust quality systems differentiate Biocon from other Indian manufacturers, the firm says, despite political turmoil in the Middle East and North Africa impacting first quarter 2015 sales.

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