MannKind’s development of new drugs with the delivery technology used in its inhalable insulin drug Afrezza will progress without founder Alfred Mann at the helm.
The US Food and Drug Administration (FDA) is encouraging hospitals to purchase their compounded drugs from organisations registered as outsourcing facilities, and has issued guidance on accreditation.
Analysts predicting a second wave of global API hubs say it will be hard for manufacturers in Latin America, Ukraine and Taiwan to avoid the pitfalls that stymied former high growth sectors in Asia.
The sharing of audit reports for active pharmaceutical ingredients (APIs) is essential in order to help avert the global decline in quality, according to Hovione’s CEO.
Ranbaxy has reported a 14% drop year-on-year of overseas revenues attributed in part to the voluntary suspension of shipments from its Toansa and Dewas facilities API facilities.
Hovione has teamed up with delivery tech developer Merrion Pharmaceuticals to provide developers of BCS class III and IV drugs with more solubility enhancement options.
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.
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.
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 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.
Daiichi-Sankyo says ensuring API supply could be a problem at Ranbaxy’s US finished product sites after imports are banned from yet another of its Indian facilities.
Azelis says its partnership with JH Nanhang (JHNH) will feed a large demand for polyvinylpyrolidones (PVP) excipients and bring the China-made ingredients to new markets.
Investing in antibody-drug conjugates (ADCs) made sense despite CMO competition and the fact few of these hybrid drugs have been approved to date says Carbogen Amcis CEO, Mark Griffiths.
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.
Swiss API manufacturer Siegfried reported that higher API sales and custom synthesis orders drove a profit increase in the first half of the year and predicted that recent capacity hike and new China plant would help maintain positive momentum.
The MHRA says it will assess the quality of active pharmaceutical ingredients (APIs) imported from outside the EU at manufacturers’ facilities rather than at UK borders.
Management and staff involved in manipulating quality data during an FDA inspection have been sacked by Fresenius Kabi as part of remediation actions at its Indian API facility.
The EMA says new import laws and international collaboration means European drugmakers can now rely on the quality of APIs made outside the European Union.
Tokyo-based API Corporation, a unit of Mitsubishi Chemical Holdings Group, is making an investment in API and pharmaceutical manufacturer Neuland Laboratories’ facilities.
Inspections in countries not expected to confirm API quality or seek exemption from new EU import regs “cannot be seen as a solution” to shortage concerns says the MHRA.
Chinese API makers will have to tell the SFDA if they have a European GMP certificate as part of a wider industry investigation prompted by new EU import laws.
UK CMP Aesica has continued its strategy of partnering with academics with a new collaboration designed to make operations at its Cramlington plant more efficient.
Brazilian regulator Anvisa has extended the deadline for public comment on plans to require excipient manufacturers to be GMP compliant after a month of industrial action by government workers.
