Jiangsu Yew Pharmaceutical outright refused permission for inspectors from Hungary to visit its site, resulting in the suspension of the company’s marketing authorisation.
Academic research underpins many of the early success stories in continuous manufacturing. Now, Blair Brettmann and her team are working to write another chapter by applying electrospinning and other techniques to downstream processing.
An improved relationship between drugmakers and excipient suppliers could help drive development in the novel inactive ingredient sector, says industry expert.
Suven Life Sciences has completed a US FDA renewal inspection at its Pashamylaram-based facility, which manufactures and supplies APIs, intermediates, and formulations.
Codexis is setting up Porton Pharma Solutions with its biocatalyst technology as part of a strategic collaboration aimed at liberating potential cost reductions of up to 20%, says CEO.
The US FDA has issued Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. a warning letter, in which it says the API maker admitted to deleting test data by accident.
Demand for a protein produced from a marine mollusk used as a carrier molecule in therapeutic vaccines has driven Stellar Biotech to expand a facility in LA.
IPEC Federation and PDA will publish a technical report in 2019 to provide drugmakers guidelines on how to implement risk assessment challenges of excipient supply.
AMPAC Fine Chemicals will boost Noramco Inc.’s supply of active pharmaceutical ingredients and intermediates to make abuse prevention and attention deficit disorder treatments, and cannabinoids.
Increased enforcement of cGMP on over-the-counter (OTC) drugs is highlighting the grey-area in classification with cosmetic products, a former FDA director says.
In response to stakeholder feedback, the US FDA has issued a final guidance detailing changes to the regulatory classification of co-crystals, from intermediate to API.
Kadam Exports Private has received a statement of non-compliance with GMP after the Danish Medicines Agency found manufacturing deficiencies at its facility in Gujarat.
Semler Research Center says the US FDA caused the “complete annihilation” of its business after regulators rejected bioanalytical studies on the back of data integrity concerns.
The International Pharmaceutical Excipient Council (IPEC) has updated its Quality Agreement guidelines to reflect changing regulatory expectations and global nature of supply chains.
The acquisition of FMC Corporation's health and nutrition business gives DowDuPont “one of the broadest pharma offerings to serve the growing excipients industry,” the firm says.
Drug firms need excipients suited to continuous manufacturing according to Dow, which says a better understanding of how products perform when used in round-the-clock production is required.
Storm Ophelia hit the Green Isle this week, forcing the closure of schools, public institutions, and a number of drug manufacturing sites across the country.
Cambrex Corporation has announced plans to start making high potency APIs at its plant in Milan, Italy citing impending patent losses for small molecule drugs as an opportunity.
BASF has announced plans for a specialty amines plant at its site on the Nanjing Chemical Industry Park in China, citing increasing demand from customers in Asia.
A new formulation of Euthyrox linked to a surge in adverse event reports in France is safe, effective and more consistent than the older version of the drug say ANSM and Merck.
Price controls and procurement programmes would favour drugs containing locally-made APIs under a Government proposal designed to reduce India's reliance on imported ingredients and intermediates.
Tesaro Inc has hired STA Pharmaceutical Co. Ltd to supply intermediates for its recently approved, $117k-a-year, ovarian cancer drug Zejula (niraparib).