The USP has clarified its proposed revision to the labelling of injectable drug vials which states that ferrules and cap overseals can only have markings intended to prevent an imminent life-threatening situation.
Lonza is manufacturing GlaxoSmithKline’s (GSK) and Genmab’s antibody Arzerra (ofatumumab), which was recently approved by the FDA, under a long-term supply deal.
Regulatory enforcement efforts to tackle counterfeit and substandard APIs are in disarray, according to Guy Villax, CEO of Hovione, who spoke at AAPS about the scale of the problem.
Abraxis Health has dedicated its manufacturing facility in Phoenix, Arizona, US which is the result of a $70m (€47m) investment to give the company the nanotech and biologics capacity needed for Abraxane production.
US contract services firm Catalent has launched a new test service capable of detecting trace amounts of the toxic chemical melamine in pharmaceuticals.
Portugese CMO Hovione has had its captisol manufacturing contract extended until 2019 in a new agreement with US specialty drugmaker CyDex Pharmaceuticals.
Israeli generics giant Teva Pharmaceutical Industries will close one of its manufacturing plants in the Czech Republic by the end of the year, resulting in the loss of around 400 jobs.
Dalton Pharma Services has rolled out a new formulation development service that completes the firm’s contract drug manufacturing offering according to CEO Peter Pekos.
Apotex’s manufacturing difficulties have begun to impact on its operations, with the company recalling some products, New Zealand authorities issuing a temporary import ban and lay offs at a supplier.
News of Bayer’s selection of ex-Thermo Fisher Scientific boss Marijn Dekkers as its CEO was somewhat overshadowed by a new FDA warning letter about quality testing at its manufacturing facility in Bergkamen, Germany.
Outsourcing-Pharma presents its latest round-up of movements in the pharmaceutical outsourcing sector, including appointments at AAIPharma, NextPharma and Catalent.
Catalent Pharma Soultions’ pharmaceutical softgels facility in Buenos Aires, Argentina has passed a US Food and Drug Administration (FDA) GMP audit and pre-approval inspection.
GEA Lyophil, part of GEA Pharma Systems, has won a contract to supply Chinjese drugmaker Zheijang Hisun Pharmaceutical with freeze drying systems and automatic loading units.
Generic drugmaker Aurobindo Pharma will add liquid-injectables to its roster of manufacturing capabilities with the purchase of fellow Indian firm Trident Life Sciences (TLSL).
Sterile injectables, specialty pharmaceuticals and discovery services will be key drivers for Jubilant Organosys over the 2010 fiscal year, according to executive finance director R Sankaraiah.
US firm Compass Pharma Services is now offering ISO class 8 certified packaging services in a bid to capture a share of the expanding high-potency drug sector.
Singapore-based Industrial cleanroom and containment specialist Esco Micro has rolled out the latest generation of its Pharmacon Downflow booths for pharmaceutical sampling, grinding, dispensing and filling operations.
3M’s drug delivery unit believes its new plasma coating and face seal valve pMDI technologies help protect APIs and will mean that more drugs can be delivered via inhalation.
PRWT Services’ acquisition of Merck & Co’s API facility helped it post a 120 per cent increase in revenues and $8.9m (€6.4m) net income in Q1 2009, overturning a loss recorded the previous year.
Fine chemicals firm Minakem believes that manufacturing capacity added by its newly acquired API plant in Dunkirk, France will reduce costs and help it compete on a global scale.
US drug firms’ qualification of overseas API vendors will be subject to increased FDA scrutiny in the coming years according to a new industry report by analysts Hogan & Hartson (H&H).
Novozymes Biopharma is building a new Bacillus-based hyaluronic acid (bHA) production facility in China to meet “increasing demand” for the substance that has drug delivery applications.
API maker Hovione’s manufacturing facility in Cork, Ireland was unveiled at an opening ceremony yesterday just two weeks after the previous owner, global drug giant Pfizer, formally handed over the keys.
Sinobiopharma is seeking a Chinese patent covering the manufacture of capsule forms of the heart drug perindopril, claiming it is the first company in the world to produce the medication in this easy to swallow format.
OctoPlus has inked a deal with a European biotech that will see it evaluate the feasibility of a controlled release formulation using its proprietary drug delivery technology.
Piramal Healthcare is switching its UK API making operations to Morpeth, Nothumberland after a downturn in the Indian CMO’s international business cut capacity utilisation at its former base in Huddersfield to just 35 per cent.
SGS Life Science Services opened a new microbiology testing laboratory in Shanghai, China to offer cGMP compliant API testing services for method development and validation.
The backlash against the re-importation bill has begun, with PhRMA warning that the legislation could cripple the FDA’s ability to protect patients and open the door to counterfeits.
The quality control systems in place at Isreali drugmaker Taro Pharmaceutical’s manufacturing facility in Ontario, Canada are the subject of a US FDA warning letter following an inspection carried out last year.
Authentication and track and trace methods, like pedigree, should be combined to provide layers of protection against counterfeit drugs according to XStream Systems’ CEO Brian Mayo.
A Chinese citizen has been fined more than $1.2m and sentenced to over six years in a US prison for distributing counterfeit drugs that appeared “identical to authentic pharmaceuticals”.
In the latest part of its “beyond our borders” scheme, the US FDA is asking drugmakers to volunteer supply chain information for drugs and APIs sourced outside the USA.
Actavis Totowa, part of Icelandic generics group Actavis, has agreed to stop selling drugs made at its facilities in New Jersey, US until the plants are made fully compliant with the FDA’s GMP guidelines.
Healthcare products company William Ransom & Son has finally published its financial results for the year ended March 31, 2008, and provided an update on efforts to turn around the troubled business.
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.
The US Food and Drug Administration (FDA) has issued draft guidance on process validation, updating its 1987 document to incorporate advances in manufacturing technology and thinking.
Manufacturers of ingredients used as excipients in pharmaceuticals have faced some regulatory problems with a series substances known as 'atypical actives'.
US Marshals have entered Celsus Laboratories to seize 11 lots of heparin, which contain contaminated material from China according to the US Food and Drug Administration (FDA).
UK drug major GSK is cutting approximately 1,000 US sales jobs by the end of 2008 as it reorganizes to compete in the increasingly tough pharmaceutical market.
Delays to US ePedigree and serialization laws, which will now not be implemented until 2015, could provide an unexpected windfall for US software firm Systech International and its PES platform.
Contracting giant Catalent says its pre-filled syringe facility in Brussels, Belgium has received Food and Drug Administration approval for the manufacture of products for the US market.
US company Ferro has said it will sell off its fine chemicals division to private equity firm Arsenal Capital Partners, which will rename the business as Novolyte Technologies, for $66m.
Ranbaxy’s antiretrovirals zidovudine, lamivudine, and nevirapine have been removed from PEPFAR’s list of approved products until ongoing GMP problems at two of the firm’s Indian manufacturing plants are resolved.
Teva and Kowa have set their sights on Japan’s $4.6bn (€3.1bn) generics market with their development and manufacturing joint venture Teva-Kowa Pharma.
Oral dose filling specialist Capsugel hopes that its new Xcelohood containment system will improve industrial weighing operations during the preparation of high-potency drugs.
