30-Jul-2015 - A drug delivery platform which increased the bioavailability of a cannabis-based drug candidate 30% could be used to boost solubility of other APIs, says Echo Pharmaceuticals.
29-Jul-2015 - Issues with batch production records at an Indian facility have landed API maker Mahendra Chemicals with a US FDA warning letter.
29-Jul-2015 - New FDA draft guidance offers drug and API manufacturers a peek into the measurements or metrics that will be used to evaluate the quality of the facilities and the processes that they use to make drugs and biologics.
23-Jul-2015 - Sandoz has revealed it will close three manufacturing sites in Germany and India.
23-Jul-2015 - Capsugel is doubling the size of a facility in Scotland to support demand for the encapsulating of drugs containing high-potency active pharmaceutical ingredients (HPAPIs).
22-Jul-2015 - Ethiopia will start making its own APIs in 2020 according to the Government which says local manufacture will improve access to medicines, curb sale of counterfeits and promote innovation.
22-Jul-2015 - Lonza has reported higher revenues and profits for H1 2015, but warned that the strength of the Swiss franc means its Visp facility is still finding it hard to compete.
22-Jul-2015 - Johnson Matthey saw lower demand for opiate APIs in the three months to the end of June, which offsett more solid performance by its attention deficit hyperactivity disorder (ADHD) drug actives.
20-Jul-2015 - AMRI has bought Spanish contractor Gadea Pharmaceutical Group for $174m (€160m) to add muscle to its steroid API business and sign up more customers outside the US.
20-Jul-2015 - API firms that invest in waste management find it hard to compete with those that pollute according to DSM Sinochem, which wants environmental criteria included in GMP standards for environmental and business reasons.
16-Jul-2015 - Drugmakers risk losing financial backing if they source APIs from Indian suppliers that pollute according to Nordea Asset Management's head of responsible investments, Sasja Beslik.
16-Jul-2015 - With no active production at the plant since 2013, the company said it would shutter its Mumbai, India-based facility in mid-September, according to a Bombay Stock Exchange filing .
15-Jul-2015 - Sandoz will shutter an Indian API facility in 2016 as part of a manufacturing refocus in the region.
13-Jul-2015 - Antibiotic API makers have an obligation to ensure their activities do not spread resistance says a group that welcomed DSM-Sinochem’s commitment to environmentally-friendly production.
13-Jul-2015 - Almost 20 API makers – mostly from India and China – have been cited by the US FDA for failing to pay their annual facility fees.
09-Jul-2015 - A new final rule from the US FDA now requires all drug and biologic manufacturers to notify the agency electronically of a permanent discontinuance or an interruption in manufacturing six months in advance, or as soon as is practical, before the disruption causes a shortage.
08-Jul-2015 - A new unit will up Hovione’s spray drying capacity 20% as it predicts a surge in demand for such a service in overcoming drug solubility issues.
07-Jul-2015 - Even if claims about Kumdang-2 are real, access to the drug and other pharmaceuticals in North Korea is limited to those who can pay black market prices according to a UK-based defector.
07-Jul-2015 - The European Commission last week officially added Israel and Brazil to a list of countries outside the EU that have standards of manufacture and supervision of APIs equivalent to those of the EU.
06-Jul-2015 - Toronto-based Attix Pharmaceuticals has received a US FDA warning letter after an inspection from November and a lack of corrective actions in the company’s response to the FDA.
On December 19, 2014, the Guideline "ICH Q3D - Elemental Impurities" was issued by the ICH, providing a global policy for l...