19-Jun-2013 - Europe could face drug shortages if the US is not granted exemption from new API import requirements, according to a US chemical industry trade association.
19-Jun-2013 - Phyton Biotech has received European approval for a version the cancer drug API docetaxel whose production does not rely on the scarce yew tree extract used in traditional manufacturing methods.
18-Jun-2013 - Shasun Pharmaceuticals’ says it is trying to restart operations at the earliest opportunity after workers went on strike at its API and formulation facility in India last Sunday.
18-Jun-2013 - The UK MHRA plans to let drugmakers import APIs that lack ‘written confirmation’ of quality if there is an overriding need to ensure continued supply.
13-Jun-2013 - The European Commission has welcomed the publication of the list of Indian API makers issued with “written confirmations” of quality by the CDSCO.
12-Jun-2013 - Some Chinese firms wont have the 'written confirmations' required to ship APIs to the EU from July according to the German audit firm tasked with helping manufacturers prepare by Beijing industry group, CCCMHPIE.
11-Jun-2013 - The Japanese joint venture between Dr. Reddy’s and Fujifilm has been called-off though both say future collaboration remains likely, especially in API production.
10-Jun-2013 - Japan has become the third country outside the EU to be exempt from providing written confirmation that APIs imported into Europe have met required standards when legislation commences on July 2nd.
05-Jun-2013 - Limited operations have recommenced at a Teva API facility in Israel after a blast that killed one and injured over 30.
05-Jun-2013 - Swedish allergy drug company Meda has denied it has been in discussions with Sun Pharma over a possible $5bn (€3.8bn) takeover.
05-Jun-2013 - Janssen has recalled 179 batches of an oral contraceptive after problems with the release of the active pharmaceutical ingredient (API) were discovered.
03-Jun-2013 - USP has decided to delay the implementation of two general chapters on elemental impurities until ICH has further established its own impurity testing requirements.
30-May-2013 - 3M says it has cooperated with the FDA and invested in its facilities in preparation of the phase-out of CFC containing metered dose inhalers (MDIs).
30-May-2013 - The US FDA is allowing Fresenius Kabi USA to import trace elements and phosphate injections from its Norway plant to help improve a critical shortage of components of total parenteral nutrition (TPN).
27-May-2013 - As new API regulations are set in July for those outside the EU, the European Medicines Agency (EMA) has unveiled what its inspectors expect to see from API manufacturer or supplier audit reports from inside the region.
23-May-2013 - Pfizer and other EU industry and academic groups are calling on the European Commission to revise its plans for authorizing and regulating ATMPs (advanced therapy medical products).
22-May-2013 - Three Canadian drug companies have issued a voluntary recall following potential contamination during manufacturing of an API by their Chinese CMO.
16-May-2013 - Lower sales of off-patent former blockbuster Lipitor have prompted Pfizer to try and sell off its third Irish API plant in as many years.
15-May-2013 - Differences in elemental impurity standards being developed separately by the US Pharmacopeia and ICH could mean costly reformulations according to a pharmaceutical, API and excipient industry coalition.
14-May-2013 - Making amide bonds may be greener and cheaper in the future according to Aesica, which has partnered with UK scientists to commercialize a new synthesis technique.
14-May-2013 - Looking to align with other industrialized nations, Canada has agreed to extend its GMP requirements for all active pharmaceutical ingredients (APIs), according to a notice in the Canada Gazette .
14-May-2013 - Large scale manufacturing contract revenue in the first quarter of 2013 increased 14% over the same quarter in 2012 as AMRI (Albany Medical Research Inc.) saw an 11% increase in overall revenue.
08-May-2013 - The EMA may recommend new daily exposure limits for some phthalates as animal data have shown they can cause negative reproductive and development effects, according to a new draft guideline .
07-May-2013 - In a rare move, the FDA has publically released Alexion Pharmaceuticals’ response to a Form 483 following inspection of its US site and the discovery of microbial contamination.
07-May-2013 - API makers Chemport and BASF have been cleared by US regulators to supply Amarin with omega-3 for its heart drug Vascepa.
Dispatches from Excipient Fest in Baltimore - UPDATE
As the USP, ICH and US FDA all aim to tackle elemental impurities testing for pharmaceuticals and...
Dispatches from Excipient Fest in Baltimore
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Injex says it is looking for partners to prefill its device and Glide will develop Pfenex’s anthrax...
International GMP standard facilities and six biopharma centres will lead Russia’s initiative in implementing its Pharma 2020...