24-Jul-2014 - Ipca Laboratories has halted shipments to the US of active pharmaceutical ingredients (APIs) made from a facility in India following a US FDA inspection.
23-Jul-2014 - Onyx Scientific has been contracted to develop and manufacture APIs for clinical trials by charitable group Cancer Research UK.
23-Jul-2014 - Johnson Matthey’s API business had a mixed fiscal Q1 with gains made in ADHD ingredients and bulk opiates being accompanied by a decline in revenue from specialty opiates.
23-Jul-2014 - As the International Conference on Harmonisation (ICH) signs off on a new tripartite guideline related to elemental impurities, the European Pharmacopoeia Commission will revise its texts to ensure consistency.
22-Jul-2014 - Scientists in Sweden have developed a magnesium carbonate-based excipient they claim is a low-cost nanotech alternative to silica for drugmakers struggling to formulate insoluble APIs.
21-Jul-2014 - Basic pharmaceuticals including APIs became even more important revenue generators for Ireland in 2013 according to new data released by the Central Statistics Office (CSO).
16-Jul-2014 - Janssen Pharmaceuticals is prepared for Tramadol's reclassification by the US Drug Enforcement Administration (DEA) and says the supply of its versions of the opioid analgesic will not be interrupted.
15-Jul-2014 - Although industry group PhRMA has called for the full implementation of a proposed rule that would allow the US FDA to destroy detained drugs deemed to be counterfeit or unapproved, the group also warns that such destruction could lead to manufacturing delays.
09-Jul-2014 - Apotex is getting reprimanded once again for its API facility in Bangalore, India, after the company failed to adequately respond to an FDA Form 483 over data integrity issues, according to an FDA warning letter dated June 16 .
07-Jul-2014 - Merck Millipore, the life sciences tools division of Merck KGaA, has launched a solid dose formulation lab in India, its first outside Europe.
07-Jul-2014 - Aarti Drugs has said it is considering buying an unnamed manufacturer in Himachal Pradesh, India to expand its drug formulations business
07-Jul-2014 - Hospira has paid Orchid Chemicals and Pharmaceuticals $218m (€160m) for an API plant in Aurangabad, India to increase its antibiotics production capacity and cut reliance on external suppliers.
03-Jul-2014 - Bulk pharmaceutical ingredients increasingly used by compounding pharmacies have seen astronomical price hikes over the past two years and now payers are catching on to the trend and stepping in.
01-Jul-2014 - Medichem has opened an API plant in Malta touting the country’s “unique patent situation” as an attractive option for generic drugmakers.
01-Jul-2014 - UK API-maker and contract research organisation (CRO) Onyx Scientific is installing equipment for continuous flow manufacturing to offer customers an alternative to batch manufacturing.
26-Jun-2014 - Dutch API and excipients distributor IMCD has increased the number of shares it will make available in its initial public offering (IPO), citing demand.
26-Jun-2014 - Oasmia Pharmaceutical AB has teamed up with a “global pharmaceutical company” interested in its vitamin A-based nanoparticle formulation tech in a move that expands its business model to drug development partnering.
24-Jun-2014 - The use of ethanol as a diluent in injectables is under the spotlight following a new US FDA warning that its presence in the cancer medicine docetaxel poses an intoxication risk.
23-Jun-2014 - Hidden costs and quality issues have encouraged pharma to abandon China and India, but Western CMOs are now under threat from a return to in-house manufacture, says a procurement consultant
19-Jun-2014 - The WHO, the United States Pharmacopeial Convention (USP) and the US Agency for International Development (USAID) will work with regulators to help countries manufacture a key tuberculosis drug.
18-Jun-2014 - Drug raw materials suppliers have not recognised their potential value to biopharmaceutical customers according to Roche which has called for a transformation in the vendor relationship.
16-Jun-2014 - A US presidential report on plans to improve chemical facility safety and security has incorporated a number of recommendations from the Society of Chemical Manufacturers and Affiliates (SOCMA).
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.
11-Jun-2014 - The European Commission (EC) can order the withdrawal of medicines that are not produced in accordance with GMP without having to prove they pose a specific health risk after a ruling in the EU Court of Justice.
10-Jun-2014 - Merck & Co. says the $3.85bn (€2.8bn) acquisition of Idenix will springboard its oral hepatitis C programme but according to an analyst is unlikely to threaten Gilead’s $1,000 pill Sovaldi.
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