Biostar Pharmaceuticals has blamed end-of-year losses on last year’s chromium-tainted gelatin scandal though it is slowly recovering following a suspension of sales enforced by the SFDA.
The US FDA is giving generic drug facilities one month to self-identify for FY 2014 so that the agency can calculate how much to charge the companies in user fees for application reviews and inspections.
US officials' new take on import rules may mean APIs destined for trials will only be allowed into the country if they are listed in an effective IND application, according to Clinipace QA chief Nikolas Burlew.
The US drought of the TB treatment isoniazid may soon ease after some manufacturers on the US FDA drug shortage list resume supply, but rationing looks set to continue for now.
The manufacturing sites of Alexion Pharmaceuticals and Italy-based Wyeth Lederle S.p.A were cited in FDA warning letters for cGMP (current good manufacturing practice) violations in their production of APIs and finished pharmaceuticals, respectively.
Bristol-Myers Squibb says shuttering Amylin’s San Diego facilities will accelerate its diabetes R&D joint venture with AstraZeneca though approximately 300 jobs will be lost.
China and India have more work to do to confirm their API manufacturing sites comply with EU GMP requirements, according to the European Commission’s Pharmaceutical Committee.
The EMA has changed how it monitors the risk-benefit profile of marketed drugs, adopting a single assessment that includes a broader range of API safety reports.
The US FDA has reprimanded and halted all imports from Japanese API manufacturer Asada Milling Co. after finding its manufacturing equipment “corroded, rusted, chipped of paint, and coated with an unidentified white powder,” the agency said in its warning...
As excipient suppliers are inundated with similar requests from users regarding quality and raw material sources, IPEC (International Pharmaceutical Excipients Council) is looking to streamline the exchange of information between the different companies.
Drugmakers Merck & Co and Eisai have both substantially cut internal data management costs through two unique off-shoring operations in China and India, respectively.
The US Environmental Protection Agency (EPA) says Teva still needs to address environmental issues at Missouri API plant landed with a $2.3m civil penalty.
Tokyo-based API Corporation, a unit of Mitsubishi Chemical Holdings Group, is making an investment in API and pharmaceutical manufacturer Neuland Laboratories’ facilities.
Cost competition and the financial crisis have slowed the growth of the global API marker over the past four years according to new data released by the CPA (Italian Chemical Pharmaceutical Association).
The EC should add the US and Japan to list of countries exempt from new API import laws and intensify talks with China and India to prevent shortages according to EFPIA.
Inspections in countries not expected to confirm API quality or seek exemption from new EU import regs “cannot be seen as a solution” to shortage concerns says the MHRA.
SAFC will expand manufacturing capacity at its facility in Irvine, Scotland, to include large-scale production of bulk dry powder media and reagents to save EU clients’ money in shipment costs.
As many as 300 API manufacturing sites will need to be inspected to prevent drug shortages after new EU import regulations come into effect this summer according to pan-European group the Heads of Medicines Agency (HMA).
The US FDA has warned API manufacturer Abbey Color about its inadequate stability program and unreliable water purification system, both of which were cited as earlier violations.
Pharmaceutical omega-3 products are important but will grow more slowly than some expect because of the long timeframe for drug approval, says the chief of the Global Organisation for EPA and DHA Omega-3s (GOED).
Excipient firms that skip lot testing or use alternative analysis methods should justify their decisions according to a new COA guide issued by IPEC Americas.
CMOs (contract manufacturing organizations) developing pharmaceutical intermediates have shifted their focus to complex nucleosides, peptides and carbohydrates over the last five years, an expert says.
Biocatalysis is emerging as a hot topic for CMOs in 2013 with AMRI, Almac and DSM all citing drug industry demand as the driver for recent collaborations.
‘Long awaited’ draft guidelines on excipient risk assessments proposed by the European Commission (EC) have been welcomed by industry group IPEC Europe.
Dow has contracted Cambrex to make its solubility enhancing polymer HPMCAS, adding manufacturing clout to its bioavailability-focused collaboration with Bend Research.
Protalix Biotherapeutics is attempting to use its US FDA-approved Gaucher's disease treatment as a proof of concept and springboard for its plant-based cell manufacturing technology.
Bristol-Myers Squibb (B-MS) will continue to make the OTCs it licensed to Reckitt Benckiser for the time being but will hand over manufacturing if the UK drugmaker buys them outright.
Formulations of two ophthalmic drugs have become the first exports to Europe from Bangladeshi company Beximco as they seek to expand into the EU market.
Teva says the offloading of its Californian manufacturing facility is part of cost-cutting plans designed to save $2bn (€1.5bn). in the next few years.
An Indian export group has published what it claims are draft CDSCO guidelines setting out what API makers must do to comply with EU import rules that come into effect this summer.
Lonza says it will “move from a product-oriented to a market-oriented organisation” suggesting a restructuring of its manufacturing division is on the cards.
