Purolite, an Ecolab company based in Pennsylvania, is a leading manufacturer of healthcare, pharmaceutical and life science products. Its affinity and ion exchange resins are used in various purification processes in the manufacture of biologics.
Portola Pharmaceuticals Inc has hired Lonza to make AndexXa (andexanet alfa), the candidate anticoagulation antidote it resubmitted for US FDA review last month.
The EMA has revised its reflection paper on API starting materials to clarify what information drug firms should provide about their starting materials under ICH Q11.
Symbiosis has opened an office in Boston, Massachusetts citing growing demand for vial filling services for highly potent APIs and large molecule injectable formulations.
Piramal chief executive Vivek Sharma won last week’s CPhI award for the pharma industry’s CEO of the year. Outsourcing-Pharma.com spoke to Sharma about his plans for the CDMO the day after the jury’s unanimous decision.
EMA guidance on process validation for drugmakers is the latest update in cGMP regulations to manage a pharma world shifting from chemical to biological processing, says NNE Pharmaplan.
‘Epoch making’ revisions to Japanese drug laws have provided a pathway for development of safer, more innovative drugs according to MHLW director, Haruo Akagawa.
The EDQM is revising its water for injection (WFI) monograph to accomodate cheaper and greener alternatives to distillation and has called on injectable drugmakers to contribute.
Celltrion has emphasised the savings Remsima ((inflizimab) could offer at a conference in Spain as partner Napp Pharmaceuticals prepares to extend the roll out of the Remicade biosimilar to the UK.
Lonza signed a flurry of biopharma-related deals and launched a number of drug industry services in the final quarter of 2014 as its efforts to focus on pharma intensified.
The US FDA says that it “becomes concerned” when excess volume in an injectable vial is greater or less than what the US Pharmacopeia (USP) recommends without proper justification, according to new draft guidance.
Ireland is seeing a renewed interest from biotech, the Industrial Development Agency (IDA) says, as Bristol-Myers Squibbs shuts a Dublin API plant to focus on biopharmaceuticals.
Cytotoxics will be a key growth opportunity for third-party manufacturers as biopharma increases its injectables outsourcing over the next few years, an industry report has predicted.
Alexion Pharma International has recalled a single lot of its monoclonal antibody (MAb) orphan drug Soliris due to the presence of visible particles in a limited number of vials.
The US FDA has waived normal pre-approval inspection requirements and cleared CMO Cook Pharmica to make an injectable drug that is currently in short supply.
The US FDA has finally adopted the revised ICH Q11 guidelines on drug substance manufacturing nearly six months after European regulators embraced the guidelines.
US CMO Pharmaceutics International (Pii) has been named as the manufacturer of the cranial bleeding treatment voluntarily withdrawn by India’s Sun Pharmaceutical Industries earlier this week.
US biosecurity experts are calling on industry and the Government to “get a handle” on the supply chain for drugs used in times of pandemic or bio attack.
US stem-cell therapy firm NeoStem predicts that output of its China-based generic antibiotics subsidiary Suzhou Erye Pharmaceutical will increase after further manufacturing approval from the SFDA.
A new study suggests pressurised carbon dioxide can accelerate crystalisation during drug production, and potentially save manufacturers time and money.
Prosonix has entered into an agreement with Trimel Biopharma, in which both companies will combine their respective technologies to deliver improved inhalation performance for respiratory medicines.
Contract manufacturing organization (CMO) ScinoPharm says strong anticancer API sales and growing demand in Europe and Asia were key to record performance in 2009.
The FDA has issued Eli Lilly with a warning letter detailing a significant deviation from cGMP at its API production facility in Puerto Rico, which makes ingredients used in Humalog (insulin lispro), a diabetes treatment.
Cambridge Consultants (CC) says experience developing auto-injector technologies was critical to its contract appraisal work during Consort Medical’s £16.8m (€11.5m) takeover of The Medical House (TMH).
The challenges in establishing a regulatory pathway for biogenerics were discussed at a recent FTC roundtable, with a FDA official saying in most cases it will be “impossible” to establish that the APIs are identical.
Arsenal Capital Partners has acquired a majority stake in Reilly
Industries for €209 million and Velsicol Chemical for an
undisclosed fee. The purchases continue a rich vein of activity for
the private equity firm, which now hold...
