Possible API Contamination at Chinese CMO Leads to Canadian Recalls

22-May-2013 - Three Canadian drug companies have issued a voluntary recall following potential contamination during manufacturing of an API by their Chinese CMO.

Pfizer Puts Lipitor Site Up For Sale as Patent Expiration Causes Over-Capacity

16-May-2013 - Lower sales of off-patent former blockbuster Lipitor have prompted Pfizer to try and sell off its third Irish API plant in as many years. 

Ranbaxy Pleads Guilty to Manufacturing Adulterated Drugs

15-May-2013 - In the largest US generic drug safety settlement ever, Ranbaxy USA has agreed to pay $500m after pleading guilty to manufacturing and distributing adulterated drugs, according to the US Justice Department settlement agreement .

Aesica Accesses Atom-Efficient Amide Tech in Academic Accord

14-May-2013 - Making amide bonds may be greener and cheaper in the future according to Aesica, which has partnered with UK scientists to commercialize a new synthesis technique.

Canada Solidifies GMP Requirements for APIs to Secure Supply Chain

14-May-2013 - Looking to align with other industrialized nations, Canada has agreed to extend its GMP requirements for all active pharmaceutical ingredients (APIs), according to a notice in the Canada Gazette .

Large Scale Manufacturing Drives AMRI Q1 Revenue Uptick

14-May-2013 - Large scale manufacturing contract revenue in the first quarter of 2013 increased 14% over the same quarter in 2012 as AMRI (Albany Medical Research Inc.) saw an 11% increase in overall revenue. 

FDA Releases Alexion Response to Form 483 on Microbial Contaminations

07-May-2013 - In a rare move, the FDA has publically released Alexion Pharmaceuticals’ response to a Form 483 following inspection of its US site and the discovery of microbial contamination.

BASF and Chemport Get US OK as Amarin API Suppliers

07-May-2013 - API makers Chemport and BASF have been cleared by US regulators to supply Amarin with omega-3 for its heart drug Vascepa.

Avoiding Cross-Contamination in Antibiotic Manfacturing, the FDA Way

23-Apr-2013 - The FDA has finalised guidance on the manufacturing of antibiotics in order to prevent cross-contamination of finished pharmaceuticals and APIs with non-penicillin beta-lactam drugs.

GSK’s Contract Manufacturing Delays Cause Shortage of Restless Leg Treatment

18-Apr-2013 - GlaxoSmithKline’s contract manufacturer has experienced unspecified manufacturing issues that are expected to set back supplies of its restless leg treatment Horizant until June. 

Metrics Latest Company to Offer Extrusion and Speronization Tech

18-Apr-2013 - Following its acquisition by Mayne Pharma, Metrics says it is to offer proprietary pellet form technology for advanced drug release and to increase bioavailability.

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Sanofi Starts Semisynthetic Malaria Drug Production

17-Apr-2013 - Sanofi has started making artemisinin using a novel semisynthetic method it says will strengthen the global supplies of malaria drugs.

US API Imports for Clinical Trials Now Require Effective IND, Expert Says

16-Apr-2013 - 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.

US FDA Calls on API, Generic Companies to Begin Self-Identification Process for 2014

16-Apr-2013 - 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.

BMS Plant Expansion to Push Biologics Development and Manufacturing

15-Apr-2013 - Bristol Myers-Squibb says its $250m (€191m) expansion of its US biologics facility will centralize its processes and become a springboard to launch new products.

GE and iBio Confirm Fiocruz Vaccine Plant Project and Predict Future Collaborations

11-Apr-2013 - GE Healthcare and iBio are in talks about future projects after confirming they are working on a plant-based vaccine manufacturing site for Brazilian drugmaker Fiocruz/Bio-Manguinhosin.

Manufacturers Partially Resolve US TB Drug Shortage, No Official Word from FDA, CDC

11-Apr-2013 - 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.

Bachem Wins Deal to Manufacture Peptide APIs for Axon

10-Apr-2013 - Axon has chosen Swiss CMO Bachem to manufacture the peptide API and finished form for its clinical trials. 

US FDA Rebukes Alexion APIs, Pfizer Italian Subsidiary in Warning Letters

10-Apr-2013 - 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.

India, China Fall Behind in Preparation for New EU API Rules

08-Apr-2013 - 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 .