Researchers believe they have found “more promising” sources of shikimic acid, a precursor in the production of Tamiflu, shortages of which have previously caused bottlenecks in producing the bird flu vaccine.
The International Pharmaceutical Excipient Council (IPEC) has unveiled plans to set up a worldwide Federation later this year to address the increasingly global excipient supply chain.
The International Pharmaceutical Excipients Council (IPEC) – currently represented by divisions in Europe, the Americas, Japan and China – could see sister organisations open up in Latin America and India in the coming months.
It is not compulsory to respond to form 483s detailing deficiencies at a facility but the FDAs latest guidance fully recommends companies do so to avoid being issued with a warning letter.
This week in-PharmaTechnologist's Pharma Phacts podcast focuses on a nanotechnology method that could produce more effective barrier packaging using less material.
An active pharmaceutical ingredient (API) pilot project, implemented by the Pharmacopoeial Discussion Group (PDG) last summer and aimed at harmonising API monographs, should generate its first results before the end of the year.
SAFC’s fourth quarter performance was hurt by dip in demand from big pharma in the US and Europe combined with lower sales to the chemical industry, according to parent company Sigma Aldrich.
Pliva is laying off 790 employees over the next 12 months following its acquisition by Teva but still intends to significantly increase API and finished product output over this period.
New research suggests that deuteration, the replacement of hydrogen atoms with heavier forms, can alter an API's crystallisation properties and help drugmakers make better more effective drugs.
Equateq is at Informex 2009 showcasing its synthesised 98 per cent pure omega-6 DGLA, use of which has previously been restricted owing to difficulties obtaining it from natural sources.
Health charity PATH has developed a formulation to stop vaccines suffering from freeze damage, which it believes will help ensure products are fully potent when they reach their destination.
A new report suggests the large numbers of fake drugs produced in China could drive CMO customers away and see Central and Eastern Europe (CEE) emerge as a contract manufacturing hotbed.
The US Food and Drug Administration (FDA) has issued a draft guidance on the measures pharmaceutical and other manufacturers should take to make sure imported FDA-regulated products are in line with federal statutes and regulations.
In the latest part of its “beyond our borders” scheme, the US FDA is asking drugmakers to volunteer supply chain information for drugs and APIs sourced outside the USA.
BayBio has called on California’s leaders to enact legislation to promote biomanufacturing in response to the aggressive policies pursued by other states.
Süd-Chemie Performance Packaging has expanded its range of bentonite desiccants, which it claims are cheaper and less environmentally damaging than silica gel alternatives.
Wyeth Pharmaceuticals is continuing efforts to improve its capabilities in the formulation and delivery of RNA through a strategic partnership with Santaris Pharma.
Since its inauguration last year, IPEC China has been working to improve the quality of excipient manufacturing in the country. in-PharmaTechnologist spoke with organisation president Nevin Cheng about the steps the body has taken so far and what it will...
Positive noises from an FDA panel on GTC Biotherapeutics’ recombinant antithrombin ATryn may further the use of transgenic animals for drug production but should the manufacturing process rather than the drug’s safety be our prime concern?
LyondellBasell, the world’s third largest petrochemicals firm and a major supplier to the drug industry, is close to bankruptcy according to widespread media reports as it struggles under the weight of a $26bn (€19.4) debt and a slump in demand for its...
US researchers have for the first time synthesised an important class of drug compounds - the aromatic polyketides - in Escherichia coli, a bacteria widely used in microbial production.
The completion of trial batches of Siga Technologies’ smallpox treatment ST-246 could not have been better timed following as it does the recomendation that the Obama government raise the threat of bio-terror up its list of concerns.
To accompany the map detailing job losses, which can be viewed here, we have picked out the details and trends from the data, uncovering the state of US pharmaceutical employment in 2008.
One of Actavis’ Bulgarian production facilities is being bought out by the management, which will provide contract manufacturing services to the generic maker and other companies.
Final guidance on the cooperative manufacture of licensed biologics has been issued by the FDA, which gives companies an outline of how to share responsibilities through the production process.
News that US drugmaker Bristol-Myers Squibb (B-MS) is using its Foam Granulation Technology (FGT) to develop a second drug has worked formulation specialist Dow Wolff Cellulosics (DWC) into quite a lather.
Research into developing manufacturing methods to produce cheap antiretrovirals in Africa has been highlighted on World Aids Day by The Council for Scientific and Industrial Research (CSIR).
Following fresh criticism of the agency’s handling of the heparin case, in-PharmaTechnologist reports on a FDA official’s explanation of the what, the when and the why of the scandal, from first deaths to continued vigilance.
Questions about the safety in children of a number of azo dye food colourings which are routinely found in pharmaceutical products could be answered within the next 18 months, according to the European Food Safety Agency (EFSA).
Taiwanese API maker ScinoPharm has been granted a US patent for new crystalline forms of irinotecan which are designed to allow for easier filtration during production processing.
The pharmaceutical industry’s vigilance in ensuring the safety of raw materials was criticised at this year’s AAPS, with significant, challenging alterations needed to improve the system.
German chemical giant BASF chose this year’s AAPS meeting in Atlanta, US to showcase its growing library of USP excipient verification certificates, making good on its commitment to apply the highest manufacturing standards to this area of its business.
Manufacturers of ingredients used as excipients in pharmaceuticals have faced some regulatory problems with a series substances known as 'atypical actives'.
Demand for glycerin as an ingredient in pharmaceuticals, personal care and other products is expected to show brisk growth out 2015, when demand around the world is expected to reach 3.39 billion pounds, according to market research firm Global Industry...
Merck Serono has begun work on the expansion of its Swiss biotech facility, with the additional capacity being used to meet rising demand for Erbitux (cetuximab).
Following Barack Obama’s victory in the race to the White House, in-PharmaTechnologist.com examines what this could mean for the pharmaceutical industry.
Isochem will have manufactured ten tonnes of the multi-purpose drug excipient vitamin E TPGS by the end of the year, marking the end of what it says has been a successful first 12 months of commercial scale production.
India’s reputation as a base for quality, low-cost drug manufacture has proved irresistible for yet another big pharma company with Japan’s Eisai unveiling plans for a new production and R&D facility.
The relentless commoditisation of glycerine ingredients prompted Dow Chemicals to all but exit the sector a few years back, but now the company says it is seeing a resurgence for its flagship synthetic glycerine brand.
US company Ferro has said it will sell off its fine chemicals division to private equity firm Arsenal Capital Partners, which will rename the business as Novolyte Technologies, for $66m.
API maker Cody Laboratories is targeting the lucrative analgesic and pain management markets with a new process that improves the efficiency of hydromorphone and hydrocodone manufacture.
The International Pharmaceutical Excipients Council (IPEC) of Europe has outlined the actions it is taking as it continues to develop awareness of the need for safe excipients.
