The FDA has issued an import alert against products manufactured at two Apotex facilities after the agency issued a warning letter, which raised several issues that the company is now working to resolve.
Bangladesh represents a “huge opportunity” to pharma, according to the CEO of Amreteck Pharma who believes that CMOs will be attracted by the low costs, which undercut China, and help the industry grow to $10bn (€6.9m) in 10 years.
CMO Encap has expanded its colonic delivery offering and is combining the technology with liquid dosage forms to provide clients with a way to administer a wide range of therapeutics to the region.
Cloud Packaging Solutions has said the acquisition of Toll Packaging will boost its ability to meet the increased demand for shorter packing runs triggered by the current global economic crisis.
CMO Avid Bioservices’ revenues rose by 74 per cent to $2.1m (€1.5m) in Q2, generating a further $7m from its parent company, and it has plans to boost output and become a leader in mammalian cell culture production.
US contract services firm PharmaForm has cut its workforce to 65 employees in a restructuring plan that parent company Akela Pharma said optimises its client support infrastructure.
US investment group JLL has described Lonza’s rival offer for Patheon as “a hostile attempt to adversely impact [the Canadian contractor’s] competitive position.”
Stemedica Cell Technologies’ new license to make stem cells for trials positions the firm as a “valuable resource for front line researchers,” according to VP of business development Dave McGuigan.
KV Pharmaceutical has begun rehiring employees to produce verification batches of certain products prior to resuming commercial manufacture, which appears to be on schedule after the FDA accepted the work plan.
Biotechnology firm Cel-Sci claims the “True Cold” low-temperature fill and finish service at its new manufacturing facility near Baltimore, Maryland is a first for the global contracting sector.
US firm PerkinElmer has opened a second plant to meet growing demand for radiolablled compounds for ADME and, it hopes, ultimately help drugmakers make go/no go development decisions earlier.
The Californian budget deficit presents a “real risk to future biotech investments”, according to the CEO of BayBio who explained to how the industry now has a difficult relationship with the state.
Pharmaceutical and cosmetics contract manufacturing organisations (CMOs) in India can now claim tax credit on their advertising spend following a recent appeal court victory for US beverage giant Coca-Cola.
Researchers believe they are a step closer to creating superefficient industrial catalysts after a team made platinum-on-gold bimetallic nanorods that are soluble in organic solvents.
CMO SynCo Bio Partners has entered the Japanese biologics production market, which it views as a growth opportunity, by signing its first contract with an emerging company based in the country.
Cobra Biomanufacturing’s new Adenovirus manufacturing and process services contract is further evidence of the health of EU biologicals market, according to business development manager Philip Ridley-Smith.
Sweden’s XSpray Microparticles says its new particle plant proves its RightSize tech can be scaled-up for industrial applications and will be a boost for its contract services offering.
Neuland Laboratories is building a facility to produce HPAPIs, which it predicts will contribute 20 per cent of its bottom line over the next two to three years, and has begun commercial peptide manufacture.
Ark Therapeutics is using its expertise and spare capacity to move into the contract manufacturing sector and is hoping to sign deals to produce the DNA-based medicine.
Researchers have presented a low cost track and trace and authentication system, which they believe could be implemented immediately, to combat counterfeiting in the developing world.
Canadian contractor Patheon has welcomed the $460m (€321m) takeover offer from Switzerland's Lonza that could, according to some observers, spark a bidding war with rival suitor, US group JLL Patheon Holdings.
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.
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.
PCAS is setting up a kilolab in California, US to target the small-scale synthesis market, which it believes will benefit its large-scale operations by establishing relationships earlier in development.
Amcor has temporarily halted trading on the Australian stock exchange, fuelling rumours that the group is finally about to move for Rio Tinto’s Alcan pharmaceutical packaging unit.
The EMEA has approved Patheon’s facility in Manati, Puerto Rico, allowing the CMO to import to Europe and improving its fortunes on the island that caused it financial problems in the past.
Biotech processes will be improved by using Sani-Tech Ultra tubing, according to its manufacturer that claims the product has a longer lifespan and lower concentration of extractables than its competitors.
India’s outsourcing sector is growing at 43 per cent, according to a new report that predicts the country will take a bigger share of the global market as concerns about operating there diminish.
Demand for downstream processing products from biotechs drove the continued recovery of Millipore’s bioprocessing division in Q2 but operating income remained flat.
AMRI’s adjusted income from operations plummeted by 97 per cent in Q2 as a result of lower demand for contract services, in particular development and small scale manufacture.
Cambrex has posted a positive set of Q2 results, recording an operating income of $9m (€6.3m), but warned that the second half of the year is likely to be down on the corresponding six months of last year.
West Pharmaceutical Services’ operating income fell by 33 per cent in Q2 but the company reported that demand for some of its drug delivery technology is strong.
Eli Lilly is among the organisations partnering to provide training for the Rozdravnadzor, Russia’s equivalent of the FDA, which is seeking to improve its knowledge of manufacturing standards.
AmerisourceBergen’s contract packaging business believes the outlook for the sector is improving after it posted an 11 per cent rise in operating income in Q3.
Shareholders have filed an $8bn (€5.7bn) lawsuit against Genzyme alleging that the company’s CEO “issued a series of materially false and misleading statements” about its manufacturing problems.
In the latest twist in an increasing bitter takeover battle, the Ontario Superior Court of Justice has rejected JLL’s bid to oust directors elected to the board of Canadian CMO Patheon in April.
Meridian Life Science (MLS) has completed the expansion of its cGMP biotech facility, which will enable the contract production of vaccines and viral based products for Phase I trials.
Mylan and the FDA appear to be in disagreement about whether investigations into quality controls at a US facility are ongoing, with both releasing seemingly contradictory statements.
Beauty packaging specialist Rexam is considering issuing new equity to service its burdensome debt pile, after market conditions failed to improve in the last quarter.
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.
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.
India’s Terrene Pharma has opened what it claims is the only gelatine capsule manufacturing plant in the country to be “designed from inception as per US FDA, EU EDQM and WHO GMP requirements.”
NextPharma Technologies’ development facility in Braine l’Alleud, Belgium has received positive early feedback following an inspection by the country’s drug watchdog, the AFMPS.
Austria’s Borealis has brought its Bormed LE6609-PH BFS grade plastic back to market in a move that, it claims, will allow converters to speed up their production cycles by reducing autoclave residence time.
Australian group Amcor has confirmed that talks about a takeover of Alcan’s pharmaceutical packaging business are still ongoing but says that no binding agreement has yet been reached.
French biopharmaceutical group LFB has contracted Lonza’s biopharmaceuticals division to make trial supplies of its candidated monoclonal anti-RhD antibody.
SAFC’s bioscience unit and Sartorius Stedim Biotech (SSB) have teamed up to create a suite of fluid management solutions that they hope will prove irresistible to the booming biomanufacturing sector.
Mallinckrodt Pharmaceuticals has recalled one batch of its sodium chromate Cr-51 diagnostic agent after FDA post-marketing tests revealed that some of the products were “subpotent.”
