17-Jun-2014 - Formulations that stop biopharmaceuticals being degraded by vials and syringes could help biopharmas avoid recalls and improve product shelf life says the UK team behind an industry focused research collaboration.
12-Jun-2014 - A European expert has cast doubt on a claim by Indian regulator CDSCO that it can assess and confirm the quality of an API supplier’s manufacturing operations in writing in just 30 days.
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for trading partners and the US FDA beginning next year, the agency is now offering pragmatic advice in the form of draft guidance for drugmakers regarding situations where suspect product might enter the supply chain.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
24-Apr-2014 - Indian authorities have suspended the manufacture of a Wockhardt fixed dose combination drug, the company has announced in a filing.
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.
NIRS Spectroscopy allows rapid (<30 s) and nondestructive screening of solid dosage forms. It requires neither sample preparation n...
Near infrared spectroscopy has been used effectively to measure moisture in a wide variety of samples. Due to the large overtone band...