Hovione's Loures plant gets latest FDA pre-approval nod
Portuguese API maker Hovione says its contract manufacturing plant in Loures has passed a pre-approval inspection by the US Food and Drug Administration (FDA).
Caraco enters into consent decree with FDA
Caraco Pharmaceutical Laboratories has entered into a consent decree with the FDA which details a series of measures that must be fulfilled to allow the company to resume manufacturing.
ATMI launches single-use powder transfer bag
ATMI has launched a powder transfer bag, for substances such as APIs and excipients, which it claims has three times the shelf life of alternatives, increases process efficiency and improves safety.
Patheon adds development services at Italian plant
Canadian CMO Patheon has set up a pharmaceutical development services (PDS) sterile products suite at its manufacturing facility in Ferentino, Italy.
Waste reduction boosts demand for deblistering, says Sepha
Northern Irish Packaging specialist Sepha says increasing pressure to reduce waste is driving drug industry demand for its range of Press-Out deblistering technologies.
FDA proposes cGMP rule for combination products
The FDA is to establish current good manufacturing practice (cGMP) requirements for combination products to eliminate inconsistencies that could affect product safety and public health.
CMIC Raves about top level accreditation for Medidata’s EDC tech
Japanese CRO CMIC says rising demand for Medidata Solutions’ Rave EDC system in Asia drove its decision to seek top-level provider status under the US firm’s accreditation scheme.
OctoPlus reduces workforce by 25% to boost efficiency
Dutch contract delivery services firm OctoPlus says it will cut 35 jobs as part of ongoing efforts to boost efficiency, improve competitiveness and broaden its client base and revenue streams.
Unlikely CEE CROs & CMOs can maintain sustainable growth; report
Fierce competition from India and China means it is unlikely that CROs and CMOs in CEE can generate sustainable growth, according to a report that believes the service model must be a “stepping stone” to creating innovative R&D businesses.
J&J buys 18% of Crucell
US health care major J&J has paid €302m for an 18 per cent stake in Dutch biotechnology Crucell and announced plans for a collaborative drug development programme.
BioVectra wins contract to make Prolanta for trials
Canadian biologics CMO BioVectra has been contracted to make trial supplies of the candidate cancer treatment Prolanta by US biopharmaceutical firm Oncolix.
Abbott beats Nycomed and UCB in battle for Solvay’s drug unit
Abbott Laboratories will buy Solvay’s pharmaceutical unit for €4.8bn ($7bn) according to reports released earlier today.
Camlin Fine Chemicals mulls API unit sale
The pharmaceutical division of Indian API maker Camlin Fine chemicals may be put up for sale by its parent company, stationary giant Camlin, after failing to expand.
Nycomed plans €75m Russian plant; may up €4.5bn bid for Solvay
Late last week Swiss drugmaker Solvay confirmed its plan to invest up to $75m (€51m) to build a new manufacturing plant in Yaroslavl, Russia.
West opens its first manufacturing site in China
West has opened its first manufacturing facility in China to meet rising demand but the process has taken since 2006 and been “very tedious”, its president of West Asia Pacific told Outsourcing-Pharma.