Taiwanese API maker Scinopharm has taken a first step towards developing its own drug portfolio in partnership with delivery tech firm Foresee Pharmaceuticals.
Danish companies that make, use, distribute or import APIs will need to register by March 1 or cease operations according to the Danish Health and Medicines Authority (DKMA).
The US wants exemption from new European Union import rules for active pharmaceutical ingredients (APIs) and says such status would cut manufacturers' admin and help prevent drug shortages.
Chinese API makers will have to tell the SFDA if they have a European GMP certificate as part of a wider industry investigation prompted by new EU import laws.
Following a wave of recent investment in ADC production, Synthon has opened an ADC manufacturing facility in Nijmegen, Netherlands, to help bring its first preclinical ADC program to clinical trials by 2014.
The cost of proposed new tests designed to ensure levothyroxine tablet quality is a small price to pay for manufacturers to ensure patient safety says the UK MHRA.
Chinese regulators have just 11 days left to define which excipients must be licensed or require DMFs under new quality regulations due to be introduced next month.
Indian drug manufacturers have 18 months to test drugs not approved by India’s Central Drugs Standard Control Organization (CDSCO) for efficacy and safety or they will be pulled from the market.
German chemicals giant BASF expects its revised takeover bid for Norwegian omega-3 API manufacturer Pronova Biopharma ASA to be accepted by resistant shareholders.
Foreign generic drug and API manufacturers will have to pay $15,000 more than their US counterparts because of additional costs required for the US Food and Drug Administration (FDA) to inspect the overseas facilities.
BASF says revised offer for omega-3 API maker Pronova Biopharma is fair value given recent Greek Government decision to stop reimbursing two key drugs.
Saltigo says climbing raw materials, energy and shipping costs prompted it to increase the price of key chemical intermediates, 1,2,4-triazole and chloroformate.
German fragrance and flavours house Symrise has just last night inked a deal with Swedish probiotics firm Probi to develop a stand-alone R&D project with oral probiotic supplements the most likely product out of the pipeline in 2014-2015.
BASF is moving en masse into omega-3 - especially if its bid for Norwegian player Pronova is approved - but it is technology gained from its May acquisition of a high-dose omega-3 start-up on a remote Scottish island, that is exciting the German giant.
Representatives from Pfizer, J&J, Dow Corning and EMD Millipore will join IPEC Americas’ executive board and lead the excipient industry organisation as it moves to a new HQ.
Last week, BASF officially opened a pharmaceutical grade omega-3 active pharmaceutical ingredient (API) facility on the Isle of Lewis, Scotland that it gained with the acquisition of Equateq earlier this year.
The US CDER wants drugmakers to find alternatives to two common plasticisers used in tablet coating after studies link them to developmental and reproductive defects in animals.
The GDUFA ‘self-identification’ requirement for generic API plants is not a flawed idea says SOCMA’s BDTF after FDA extends registration deadline citing fewer than expected registrations.
BASF’s ever-expanding nutrition unit says its €644m bid last week bid for Norwegian omega-3 firm, Pronova Biopharma, is as important for its food supplements business as its pharmaceutical operations.
Rousselot has said it plans to increase gelatine prices 7% up to low double digit levels for 2013 as continued growth in demand has not been met by raw material supply.
Production by Ireland’s pharmaceutical sector fell sharply in September but it is too early to say if it was part of a longer term decline, says the CSO
The positive impact drug industry demand for quality is having on the fine chemicals sector was evident at industry trade show CPhI last month according to expert Jan Ramakers.
