Germany-based CMO CPM Contract Pharma was hit with the first US FDA warning letter for failing to self-identify its manufacturing facility and pay the facility fee required by the Generic Drug User Fee Amendments of 2012.
India’s Supreme Court has called for all of the data supporting the approval of 162 clinical trials between July and August of this year by the Drug Controller General of India.
The US House on Saturday passed legislation that calls for the tracking and tracing of pharmaceuticals through the nation's supply chain after agreeing on the bill with the Senate last week.
US authorities are holding more excipient imports at ports according to industry group IPEC Americas, which said that the increase has already halted the production of at least one drug.
US scientists have claimed that ‘bacterial autopsies’ could accelerate the discovery of new antibiotics in an announcement made just days after the US CDC warned of a potential “post-antibiotic era” and called for renewed development efforts.
After more than a year delay, IPEC India is expected to be created by the end of the year after IPEC-Americas’ vice chair confirmed that the registration process is moving forward.
After finding cGMP violations at another Ranbaxy plant in India, the US FDA on Monday issued an import alert that effectively stops all of the plant’s drug shipments from entering the US.
Aurobindo Pharma has given more details of a planned expansion of its API and antibiotics businesses and has confirmed its intention to rejig its injectables operations.
Johnson & Johnson is battling another onset of quality concerns as its subsidiary Janssen is pulling one lot of its Risperdal Consta injection in the US due to a mold contamination.
Cargill says interest from the pharma industry for its seaweed-derived excipient is growing as it invests $15m (€11.3m) into its French alginate production plant.
The EU’s CHMP(Committee for Medicinal Products for Human Use) will delay the application of a guideline that would set limits on metal catalysts or metal reagent residues until the ICH finalizes its own guideline on the issue.
The US FDA has released a Q&A to offer more clarity to GPhA, Cipla, Akorn and other drug and API manufacturers who responded to the initial stability draft guidance for ANDAs.
Aoxing Pharmaceuticals reported increased sales and lower operating expenses for Q2 2013 one year on from the chromatin-tainted gelatin scandal that led to suspension of sales by China’s regulators.
Swiss API manufacturer Siegfried reported that higher API sales and custom synthesis orders drove a profit increase in the first half of the year and predicted that recent capacity hike and new China plant would help maintain positive momentum.
Amgen has spent $10.4bn (€7.8bn) in acquiring Onyx Pharmaceuticals saying its oncology products and pipeline will be strengthened by Amgen’s manufacturing capabilities.
Jubilant HollisterStier (JHS) says expansion of its sterile manufacturing capacity at its facility in Kirkland, Canada will be used to fulfill several new contracts.
The two-year pilot project will help the US Food and Drug Administration further assess the growing number of companies and countries involved in importing drugs to the US.
Consolidating its Indian injectable business under a new subsidiary will improve focus and align quality control, says Aurobindo who has invested in two manufacturing companies to support such plans.
ScinoPharm and Sundia MediTech have teamed up to try and win business from international drugmakers that - they say - want to simplify outsourcing to China.
US and foreign generic drug manufacturers will see a more than $40,000 increase in US FDA facility fees for 2014, while API manufacturers will see a more than $8,000 increase.
EMD Millipore says while voluntary excipient quality schemes are step in the right direction, formal GMP and enforcement would create a level playing field.
Delays are annoying. Whether you are a journalist trying to ask a few quick questions without involving teams of public relations people or a driver stuck in a traffic jam, delays are normally a bad thing.
Management and staff involved in manipulating quality data during an FDA inspection have been sacked by Fresenius Kabi as part of remediation actions at its Indian API facility.
The current US shortage of tetracycline is not likely to be resolved any time soon because of ongoing manufacturing and raw material supply issues according to the US FDA.
