A collaboration to develop portable, flexible and continuous processing systems has the potential to transform oral solid dose (OSD) manufacturing, according to Pfizer, GEA and G-CON.
US authorities are holding more excipient imports at ports according to industry group IPEC Americas, which said that the increase has already halted the production of at least one drug.
After more than a year delay, IPEC India is expected to be created by the end of the year after IPEC-Americas’ vice chair confirmed that the registration process is moving forward.
Cargill says interest from the pharma industry for its seaweed-derived excipient is growing as it invests $15m (€11.3m) into its French alginate production plant.
The global pharma packaging market - worth $47.5bn (Eur35.87bn) in 2011 - is expected to grow to $73bn in 2018, with a CAGR of 5.6%, according to a report by Transparency Market Research.
The EU’s CHMP(Committee for Medicinal Products for Human Use) will delay the application of a guideline that would set limits on metal catalysts or metal reagent residues until the ICH finalizes its own guideline on the issue.
Aoxing Pharmaceuticals reported increased sales and lower operating expenses for Q2 2013 one year on from the chromatin-tainted gelatin scandal that led to suspension of sales by China’s regulators.
Codexis has denied breaching its licensing deal with Dyadic International and says losing rights to the C1 fungal expression system would hit its CodeXyme business hard.
Enteris has acquired an oral drug delivery platform from Unigene Laboratories and says the excipients used can increase solubility and absorption for both peptides and small molecules.
EMD Millipore says while voluntary excipient quality schemes are step in the right direction, formal GMP and enforcement would create a level playing field.
Delays are annoying. Whether you are a journalist trying to ask a few quick questions without involving teams of public relations people or a driver stuck in a traffic jam, delays are normally a bad thing.
The US FDA has amended the list of draft guidance documents it expects to release for the rest of the year with two new guidance topics, one deleted guidance and a few other hotly-anticipated documents still to come.
Dry powder inhaler firms may soon be able to eliminate lactose from formulations if a new high dispersibility particle production platform is successful in trials.
Chinese understanding of European CEPs is good, but some manufacturers are still unclear on the related obligations and requirements according to auditing firm, blue inspection body.
A new high-intensity sweetener-based reformulation approach could improve compliance among Alzheimer’s patients and make dose adjustment easier says Tokyo drugmaker, Eisai.
India’s top drug regulator is calling on manufacturers that received unauthorized drug approvals and manufacturing licenses to prove the safety and efficacy of their marketed drugs by August 31.
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.
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.
USP has decided to delay the implementation of two general chapters on elemental impurities until ICH has further established its own impurity testing requirements.
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.
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.
Revised excipient guidelines expected from Brazilian regulator Anvisa this year will reduce confusion and further align standards with those in the US and EU says an industry expert.
Dispatches from Excipient Fest in Baltimore - UPDATE
As the USP, ICH and US FDA all aim to tackle elemental impurities testing for pharmaceuticals and excipients, questions still remain on whether the manufacturers will be able to comply with the looming requirements.
China’s implementation of GMPs for excipient manufacturers, as well as a developing US FDA-style DMF system, have added another layer of safety requirements but challenges remain for the regulators in ensuring compliance, experts say.
The inventor of a reagent recently found to be highly explosive says many drug production chemicals may have similar profiles and that knowing how to handle them is the key.
BD says a brand new facility and sustainable pricing will allow the company to compete as it enters the generics market following FDA approval of its first injectable drug.
As excipient suppliers are inundated with similar requests from users regarding quality and raw material sources, IPEC (International Pharmaceutical Excipients Council) is looking to streamline the exchange of information between the different companies.
Tokyo-based API Corporation, a unit of Mitsubishi Chemical Holdings Group, is making an investment in API and pharmaceutical manufacturer Neuland Laboratories’ facilities.
Catalent says it has acquired a Chinese softgel producer to expand its drug delivery offerings and expects more investments to come as part of a two-pronged plan into China.
Patheon says the shuttering of one of Banner’s manufacturing sites is necessary in integrating the recent acquisition into its global business structure.