Capsugel is no longer a simple capsule provider but a differentiated player in the CDMO industry, the firm says as it wins a scale-up manufacturing contract for Chiasma and Roche’s oral octreotide candidate.
Swiss high potency active pharmaceutical ingredient (API) contractor Cerbios has broken ground on a building that will bring together its chemical and biological R&D departments.
Albemarle has agreed to sell its ibuprofen business to US chemical intermediates firm SI Group in a deal that will also see it divest the anaesthetic agent, propofol.
The amines market will grow 5% over the next decade according to BASF, which cited rising drugmaker demand as a key driver for its investment in a new German plant.
Pfizer has reminded the creator of Viagra-flavoured ice cream that the blockbuster erectile dysfunction treatment should only be available on prescription.
Acura has reacquired the rights to its opioid abuse-deterrent technology from Pfizer and is looking for pharma partners to relaunch its oxycodone HCL drug Oxecta.
Inspecting the thousands of Chinese factories making APIs for the US market is a “hopeless task” even if the FDA gets the extra staff it wants according to a Congressional committee review.
IPEC Americas has released a standardized letter and template that pharmaceutical companies can use to collect available information from their suppliers regarding elemental impurities in excipients.
Fungi have no place in an API facility, but soon enzymes derived from them may be commonplace say scientists developing oxidoreductases for cost and time saving industrial applications.
Enzyme experts trying to make the anticancer APIs vincristine and vinblastine with engineered cell lines say the technology could be used to produce a wide range of plant-derived drug actives including alkaloids like morphine.
GlaxoSmithKline has issued a recall of its antidepressant drug Paxil after receiving a US FDA Warning Letter for failing to fully investigate contamination issues at an Irish API plant.
AMRI will acquire Cedarburg Pharmaceuticals for $38.2m (€27.7) in cash, plus $2.8m of assumed liabilities, to expand its API and drug development offerings.
The thin profit margins associated with relatively simple sterile products has led to a reluctance to invest in operations and shortages, according to an industry expert.
Efforts to cut industrial energy bills in the UK's 2014 Budget have been welcomed by the Chemical Industries Association (CIA), a group whose members include drug and ingredient makers.
Drugmakers were replaced by buyers of cosmetics, hygiene and material protection ingredients as Lonza’s biggest customers in 2013 according to a report released by the Swiss CMO today.
The Board of Directors at Indian firm Orchid has approved the sale of its API business to Hospira, bringing the acquisition a step closer to completion.
Aesica has predicted that CMO sector consolidation will continue and hinted that it is considering strategic acquisitions as a part of a bid to generate $1bn revenue.
Australia may lose its status as the leading supplier of pharma grade opium if it does not comply with Big Pharma requests and allow cultivation of the crop on the mainland.
Access to mixed hydrocodone painkillers such as AbbVie’s Vicodin will be restricted and production limited if plans by the US Drug Enforcement Administation (DEA) are cemented later this year.
Ireland remains a significant small molecule drug manufacturing hub the Industrial Development Agency (IDA) says, despite a number of API plant closures.
Nearly a quarter of drugs made in Jammu & Kashmir and 10% of those produced in Himachal Pradesh are substandard according to new testing data published by CDSCO.
Publication of a US FDA enforcement report detailing a recall by Ranbaxy in January saw the beleaguered Indian drugmakers’ share price fall 3% last week.
Drug excipient makers in India and those serving the market have a dedicated IPEC chapter after the delayed fifth branch of the industry group was finally formally incorporated at the end of January.
Criminal access to APIs must be cut off in a way that does not infringe generics companies’ right to buy chemicals, a top US prosecutor told In-Pharmatechnologist.com.
Pharma industry employees and wholesalers with access to narcotic APIs would be subject to background checks and drug testing under new proposals being considered in the US.
FMC has hired Connell Brothers (CBC) to distribute its drug excipients in Japan, citing the move as a key step to building its business in the country.
Ranbaxy has temporarily halted all shipments from two API plants currently under a US FDA consent decree, although both the firm and an analyst say a shortage is unlikely.
AMRI says it intends to expand its API business to target both generics and more complex molecules after reporting record full year revenue from contract services.
A US attorney who worked with Pfizer, Lilly and Merck to jail drug counterfeiters says cutting off criminal access to active pharmaceutical ingredients (APIs) is key.
NSF International has acquired the auditing subsidiary of the International Pharmaceutical Excipients Council of the Americas (IPEC) as part of a way to ensure a more streamlined supplier qualification process.
The team behind the scheme that helped BASF, Seppic and Merck KGaA reduce their audit burdens expect more excipient suppliers to seek certification as an independent association.
Northwest Biotherapeutics has agreed with CMO Cognate Bioservices to begin a large-scale expansion of the manufacturing, storage, handling and distribution of its personalized immune therapies for solid tumor cancers.
