Fine chemicals manufacturer Ashland has laid down plans to expand a Klucel hydroxypropylcellulose (HPC) plant in Virginia to meet growing pharma demand.
A previously unknown signaling platform may be responsible for the success of the main psychoactive ingredient in cannabis in reducing tumour size, which also may lead to the development of a synthetic THC equivalent, scientists say.
The tightening federal budget is increasing competition between research institutes and academia when it comes to preclinical toxicology testing, according to MRIGlobal.
US and foreign API facilities will see their annual US FDA facility fees rise more than $5,000, while their FDF (fixed-dose form) counterparts will see their fees rise by more than $20,000.
The Health Products Regulatory Authority (HPRA) of Ireland has published a list of 12 active substances contained in medicines that could potentially be switched from prescription-only to over the counter sale.
Ipca Laboratories has halted shipments to the US of active pharmaceutical ingredients (APIs) made from a facility in India following a US FDA inspection.
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.
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.
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.
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).
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.
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...
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.
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.
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.
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.
Dutch API and excipients distributor IMCD has increased the number of shares it will make available in its initial public offering (IPO), citing demand.
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.
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.
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
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.
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.
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).
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.
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.
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.
ScinoPharm Taiwan on Monday signed a manufacturing and clinical supply contract with TaiGen Biotechnology to provide the API for Burixafor, a potential stem cell treatment.
European regulatory authorities have reinstated the Good Manufacturing Practice (GMP) certificate at Ranbaxy Laboratories’ API manufacturing site in Toansa, India, which was suspended in January.
Johnson Matthey has completed restructuring its API unit and plans to pursue more generics industry business, after non-branded drug launches drove fine chemicals growth in fiscal 2014.
The Active Pharmaceutical Ingredients Committee (APIC) has unveiled a new guidance document for API distributors that seeks to provide step-by-step instructions on how to meet WHO and European Union guidelines on the distribution of APIs.
Provence Technologies, a French chemical developer, has acquired the active pharmaceutical ingredient (API) maker Synprosis, a specialist in synthesising long-chain peptides.
As WuXi talks of a surge in its outsourced manufacturing services, the company has begun offering high-potency active pharmaceutical ingredients (HPAPIs).
Microscopic worms exposed to the diabetes medication metformin live longer because the drug makes them produce more free radicals according to a new study that has implications for human health and advocates of “anti-aging” antioxidants.
The Form 483 from the US FDA cited Chicago-based Morton Grove Pharmaceuticals, which was acquired by Wockhardt in October 2007, for 12 different observations.
SOCMA’s (Society of Chemical Manufacturers and Affiliates) Bulk Pharmaceutical Task Force has written a letter to the US FDA taking issue with what may amount to a 40% drop in domestic API inspections for FY 2015.
California-based Relypsa has entered into a seven-year commercial manufacturing and supply agreement with DSM Fine Chemicals for the API for patiromer, the company's novel polymer in development for the treatment of hyperkalemia. Financial details...
AMRI has upped its guidance following a quarter that saw unprecedented demand from its once-troubled Burlington plant and the integration of recent acquisition Cedarburg commence.
Scientists are scouring the seas for novel bioactive compounds as part of PharmaSea, a four-year project which has already turned up interesting compounds from samples of mud, sediment and sea life.
Aesica has secured a Technology Strategy Board grant to fund a high-value chemical manufacturing process with the winning process set to improve the sustainability of an active pharmaceutical Ingredient (API).
Colorcon today opened an expanded facility in Goa, India to scale up production of tablet coatings and excipients for pharmaceutical manufacturers in South Asia.
Experts have predicted emerging Indian and Chinese markets will outpace Western markets as the $2.3bn oral solid dosage form (OSDF) excipients global market grows at a sustainable rate.
