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US FDA offers new supply chain security guidance

12-Jun-2014 - As manufacturers will have to identify illegitimate product for trading partners and the US FDA beginning next year, the agency is now offering pragmatic advice in the form of draft guidance for drugmakers regarding situations where suspect product might enter the supply chain.

Fight the Fakes campaign adds bevy of new partners

11-Jun-2014 - The advocacy campaign to raise awareness about falsified and fake drugs has added 11 new partners to its cause, including US-based GPhA (Generic Pharmaceutical Association).

Rx-360 pushes into China with new working group

11-Jun-2014 - Supply chain security consortium Rx-360 has shifted its focus to China where it is forming a working group to further ensure compliance in a country that has had some difficulties with spurious drugs in the past.

Wockhardt’s Illinois manufacturing facility hit with FDA Form 483

04-Jun-2014 - The Form 483 from the US FDA cited Chicago-based Morton Grove Pharmaceuticals, which was acquired by Wockhardt in October 2007, for 12 different observations.

Another Soliris recall as Alexion evaluates its manufacturing network

03-Jun-2014 - Alexion has recalled another nine lots of Soliris after finding "visible particles" in vials of the $600,000-a-year  drug for the third time in 10 months.

Operation Pangea takes another crack at illegal drugs, websites

27-May-2014 - For the seventh time since 2006, law enforcement, customs, and regulatory authorities from 111 countries collaborated to identify and root out Internet-based makers and distributors of illegal drug products and medical devices.

Sun Pharma hit with warning letter over missing data, data handling issues

22-May-2014 - Amid ongoing efforts by the US FDA to crack down on foreign suppliers not meeting cGMP (current good manufacturing) requirements, India-based Sun Pharma is the latest company to be hit with a warning letter.

Fresenius Kabi, Abbott acquisitions reveal burgeoning Latin American market

21-May-2014 - Both Fresenius Kabi and Abbott have extended their operations further in the Latin American market with new acquisitions that signal growth in the region.

US FDA to launch new supply chain initiative with EU counterparts

15-May-2014 - As the worldwide pharma supply chain gets even more complex, the US FDA is looking to leverage its existing relationship with its EMA (European Medicines Agency) counterparts to boost drug quality with a new initiative.

Semiconductor experiments look to control crystallisation

15-May-2014 - Experiments on semiconductors reveal a new way to study and control crystallisation. The discovery has relevance to pharmaceutical manufacturing as many drugs are made from small molecules that must crystallise in just the right way to have the proper effect.

Brazilian court charges Lilly $450m for hazardous chemicals at manufacturing facility

13-May-2014 - A Brazilian Court in Sao Paulo has ordered Eli Lilly pay about $450m for exposing former employees of its subsidiary to hazardous substances in a manufacturing facility operated between 1977 and 2003.

Fake OTCs becoming more common, says ex-DOJ prosecutor

12-May-2014 - The counterfeiting of over-the-counter drugs is a growing problem according to an ex-criminal prosecutor, but the nature of such medicines means the problem often goes unreported.

India looks to attract more trials with new compensation formula for participants

09-May-2014 - As part of an effort to provide more certainty, India’s CDSCO (Central Drugs Standards Control Organization) has offered up a new compensation formula for trial participants who are killed or injured during a trial.

Hospira: New Vizag plant online this year despite US FDA 483

05-May-2014 - Hospira says approval for its new manufacturing facility in India is still on track despite receiving a Form 483 form the US FDA with ten observations.

API facility issues cause FDA to reject Pozen drug candidates

29-Apr-2014 - Deficiencies of at an unnamed API supplier caused the US FDA to reject Pozen’s aspirin-based drug candidates with a complete response letter (CRL).

News in brief

Strides Arcolab wins FDA approval for India facility

28-Apr-2014 - Strides Arcolab announced Friday that its oral dosage manufacturing site in Bangalore, India, was recently approved by the US FDA following a GMP compliance audit. 

Indian state regulator suspends manufacture of drug at Wockhardt plant

24-Apr-2014 - Indian authorities have suspended the manufacture of a Wockhardt fixed dose combination drug, the company has announced in a filing.

Hospira announces two US recalls due to manufacturing, supplier issues

22-Apr-2014 - Hospira has announced US recalls for seven lots of its propofol injection and one lot of 1% Lidocaine HCI Injection due to a glass contamination.

USCC: making sure Chinese APIs are safe is “hopeless task” for US FDA

14-Apr-2014 - Inspecting the thousands of Chinese factories making APIs for the US market is a “hopeless task” even if the FDA gets the extra staff it wants according to a Congressional committee review.

EMA requests more stability data for some manufacturing changes

14-Apr-2014 - Drugmakers in the EU making changes to their manufacturing processes will have to submit additional stability data, according to a new EMA (European Medicines Agency) guideline.

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