CordenPharma has implemented work to improve its quality and compliance systems after its Latina facility was issued a warning letter from the US FDA in May of last year.
Hikma has ramped up capacity at manufacturing facilities in the US and Portugal manufacturing to meet the growing demand for its lyophilised and oncology products.
ScinoPharm has emphasised its compliance with waste water treatment rules, weeks after being contracted to supply API for Melinta Therapeutics’ antibiotic Baxdela.
Pfizer has chosen a site in Sanford, North Carolina for a gene therapy production plant, just 40 miles from its recent acquisition Bamboo Therapeutics Inc.
The US FDA has issued a complaint against an outsourcing facility that purportedly manufactured and distributed sterile drug products in violation of the DQSA.
San Diego-based contract development and manufacturing organization (CDMO) has signed a drug product development, manufacture, and stability studies contract.
BASF has set up a pharmaceutical technical laboratory in Navi Mumbai, India citing Asia’s fast growing generic drug manufacturing sector as its target customer base.
CMC Biologics and Trellis Bioscience have entered into a manufacturing agreement for the process development and production of two of Trellis’ monoclonal antibodies (mAbs).
A lyophilisation expansion announced in 2013 at an aseptic facility in Wasserburg, Germany has been delayed due to lengthy approval processes, says Recipharm.
The Chinese pharmaceutical industry sets a positive outlook for regulatory harmonization as its Marketing Authorization Holder pilot program progresses.
BASF SE has selected the Icertis Contract Management (ICM) platform to automate its contracting processes and improve visibility into contractual obligations and deviations.
Citing safety concerns, drug industry stakeholders and public health organizations are urging lawmakers to uphold FDA oversight and enforcement of the 2013 Drug Quality and Security Act (DQSA).
GSK has announced a shakeup of its UK network, shelving plans for Ulverston biopharma plant, mooting the sale of its cephalosporin antibiotics business and pledging to invest in HIV and respiratory drug capacity.
Researchers developing a method to determine drug bioavailability say the approach could become a ‘shortcut’ for scientists in drug discovery and development.
India-based Alembic Pharmaceuticals has inaugurated its manufacturing facility in Panelav, Gujarat, where the firm will make generic oncology products for international markets.
The pharmaceutical industry and regulators are preparing for Brexit and how to best “manage and mitigate” any potential risks the UK’s departure from the EU may pose.
PCI Pharma Services continues to expand its serialization capabilities following an extended regulatory deadline that will provide much-needed “breathing room” for the industry.
Merck KGaA has announced a plan to close some EU production sites and invest in others, citing the centralization strategy employed by Sigma-Aldrich as inspiration.
Cell therapy firms will be able to authenticate the foetal bovie serum (FBS) they use through a testing programme launched by GE Healthcare and Oritain.
AstraZeneca has committed A$100m ($76.4m) to expand its manufacturing facility in Sydney Australia, citing growing demand for asthma medications in China.
German Merck and Sigma-Aldrich broke EU merger procedures and could face a fine equivalent to 1% of the combined firm's annual revenue according to the European Commission
Patheon NV has announced it will spend $45m to expand and enhance its manufacturing network citing customer demand for more reliable, flexible and cost-efficient supply chains.
Pfizer says a lack of harmony among regulators made its continuous granulation platform untenable for bulk manufacturing but is positive about using such tech for smaller volumes.
Avista Pharma Solutions, Inc. has been contracted to manufacture an opioid-derived small molecule, which is a component of a conjugate vaccine being developed to treat opioid addiction.
