Issues in the quality testing of drug substance and product were among eight observations cited in a Form 483 following an inspection at Biocon’s site last month.
Patheon believes it can triple revenues at its recently acquired Roche facility in South Carolina due to a shortage of Western active pharmaceutical ingredient (API) capacity.
The CRO market in Asia has “massive implications” as it continues to emerge as a preferred destination for clinical trials – a global market expected to reach $57bn by 2020.
GSK has warned that Donald Trump’s plan to encourage US drug production through import tax hikes must take the global nature of pharma supply chains into account.
Biocon has been awarded a three-year contract to supply recombinant human insulin formulations made at its Malaysian facility to the country’s Ministry of Health.
The US FDA is inspecting more foreign plants but has not shown if its efforts have improved the quality of API and drug imports according to a GAO report.
Catalent has become the first CDMO to join the PSCI – a voluntary industry initiative focused on the social, environmental and economic impact of the supply chain.
Smaller drugmakers are shifting away from generics and towards niche new molecules says Recipharm, which has expanded a small-scale API facility to feed demand.
The Chinese Food and Drug Administration (CDFA) has fired back on lack of context in media reporting “80% of China’s clinical trial data are fraudulent.”
UK-based contract manufacturers are benefitting from the weak pound following the country’s referendum in June, but the long-term impact of Brexit is still unknown.
The 315 square meter facility will house more than 30 employees in Warsaw, Poland, where the company contract research organization (CRO) has operated since 2008.
iCardiac Technologies and SNBL CPC Japan, a Japanese-based Site Management Organization (SMO), will collaborate on cardiac safety studies in the country.
Hikma invested over $25m in its US facilities in the first half 2016, and plans to use excess capacity at a former Boehringer Ingelheim plant for contract manufacturing.
Marken’s Moscow-based depot has been granted a new pharmaceutical license from the Russian Federation, further extending the company’s capabilities in the area.
GSK will pump £275m ($360m) into its UK manufacturing network and says the country has a “leading position in life sciences” despite the recent Brexit vote.
Brexit: Indian firms worried but Big Pharma and EMA remain positive for now
ClinTec International has opened two new offices in Spain as it prepares for an expanding local clinical trial portfolio and larger outsourcing engagements in the country.
Anti-LGBT legislation has prompted Braeburn Pharmaceuticals to reassess plans for a $20m facility in North Carolina, but will others in "the nation’s number one state for biomanufacturing" follow suit?
Recipharm will invest €40 in serialization equipment to ensure it can comply with evolving track and trace regulations in the US, Europe and other markets.
AstraZeneca has reformulated roxadustat using materials sourced in China to make it eligible for fast track review through the country's new "green pass" process.
Indian drugmaker Strides Shasun has bolstered its generics manufacturing network by acquiring stakes in Kenya’s Universal Corporation and Australia’s Generic Partners Holdings.
Incoming Indonesian government measures to attract foreign manufacturing joint ventures (JVs) could include a regulation to reduce API imports, Vincent Harijanto, committee head GP Farmasia said.
Ipca has received an FDA Warning Letter at three Indian API facilities, but says it awaits re-inspection after already rectifying issues highlighted in a 2014 Form 483.
Plans to centralise its manufacturing operations will optimise use of new technologies across Novartis’s divisions without resulting in any additional facility closures, the firm says.
More plants in China will close says a US-based analyst who predicts that some drugmakers' inability to comply with stricter quality rules will create an opportunity for those that can.
The recent tide of Warning Letters issued to Chinese API and finished formulation makers reflects an increase in regulatory oversight, the US FDA says.
