The pharma industry is underprepared for the upcoming global regulations says Recipharm, which has inked three new tech deals as part of its €40m serialisation effort.
Juniper Pharma Services has invested in a tablet press that can produce 42,000 pills an hour citing customers’ clinical trial supply needs as the driver.
Valeant will transfer production tech and modernise a controlled-release finished formulation facility as part of a $27.5m (€24m) investment in its Canadian manufacturing network.
Pfizer broke ground on its new Andover, MA-based biologics clinical manufacturing facility this week, which will feature single-use and disposable technologies.
The US FDA has banned Phalanx Labs from shipping products to the US after the Indian API and intermediates firm refused to let inspectors visit its site in Visakhapatnam.
The global contract development and manufacturing organization (CDMO) announced that its Durham, North Carolina-based facility completed a successful US Food and Drug Administration (FDA) inspection.
CDSCO has renewed a number of API firms’ ‘written confirmation’ documents – which are needed to ship to Europe – days after an industry group called for renewals without re-inspection citing trade concerns.
The UK MHRA has identified GMP deficiencies at an Akums Drugs & Pharmaceuticals facility in India that was being lined up to make progesterone for Nordic Pharma.
The US FDA says Ko Da Pharmaceutical facility in Taoyuan City, Taiwan will not be able to supply the US unless the firm corrects all GMP deviations identified during an inspection last May.
The new 50,000 square foot facility in Lexington, MA will be dedicated to late phase development and commercial manufacturing for advanced cell and gene therapies.
Cobra Biologics has teamed up with Touchlight to test an AAV vector production platform they claim will make manufacturing gene therapies for trials cheaper and faster.
A new $60m facility at a MSD site in Ireland will offer Fujifilm Diosynth customers 20,000L of microbial biologics capacity in a collaboration between the two firms.
CMC Biologics as upped its production capacity at its Copenhagen facility with plans to have equivalent capacity on both sides of the Atlantic in 2017.
The US FDA has told Megafine Pharma it must determine the extent of data falsification at the plant in Nashik, Maharashtra that was banned from shipping APIs to the US last year.
Xellia Pharmaceuticals has started building a stability and release-testing unit at its API facility in Budapest, Hungary that is designed to support increased output.
The UK Cell and Gene Therapy Catapult (CGT) will test a “scaffold” technology its Australian developers say could make T-cell production more efficient.
Selcia has opened a production facility for 14C radiolabelled drug ingredients in the UK citing growing demand from CROs and sponsors running first-in-man studies.
Aesica Pharmaceuticals has adopted a flexible serialization system capable of helping customer meet track and trace requirements in China, Korea and other key markets.
Ajinomoto Althea has been granted a US patent for a whole antibody crystallization method that is faster at producing stable, biologically-active crystals than current techniques.
According to the most recent Biopharma CEO Confidence Index, CEOs are shifting their focus back to their pipelines and have plans to increase outsourcing.
As “one of the fastest growing areas in pharma,” the demand for finished dosage formulations is having an impact on several aspects of the CMO industries.
Suir Pharma is set to close or be sold with the loss of 130 jobs less than a year after it was acquired by Slovakian API manufacturer Saneca Pharmaceuticals.
Juniper Pharma Services has upped mixing capacity at its facility in Nottingham, UK to give it the ability to support Phase III studies of topical and semi-solid products.
