Emcure’s Tillomed has been forced to withdraw its application for a version of doxorubicin, in light of the EMA taking a closer look at medicines for which study data prepared by Panexcell Clinical Laboratories was used to support marketing authorization applications.
Tillomed Laboratories has pulled its application for a hybrid version of the chemotherapy agent doxorubicin, falling victim to the European Medicines Agency’s review into medicines for which studies were conducted at a site ran by Panexcell Clinical Laboratories.
Although results of a bioequivalence study suggested that the Emcure subsidiary’s doxorubicin hydrochloride products were comparable to the reference brand,...
Amneal has marked its entry into China after receiving its first product approval in the market. Meanwhile, the firm has also outlined US approvals for two generics currently suffering from shortages.
Avoiding disaster at the beginning of the pandemic and offering a pro-active supply chain blueprint should position the generics industry well for an onshoring debate in Congress, but a look back at March 2020 is a reminder that even small policy shifts can have a big impact.
After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.
Nichi-Iko says that remediation activities at its Toyama plant in the wake of a suspension over GMP violations mean that there may be delays to supply.
After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.
Laboratorio Elea has struck a deal with Nichi-Iko Pharmaceutical to market the Japanese firm’s infliximab biosimilar in Argentina.
Biocon has made two key appointments to the management team of Biocon Biologics following a recent change in CEO for the biosimilars business.
