With Hikma having launched the first generic version of Vascepa (icosapent ethyl) in the US last year, Amarin has again raised the issue of ANDA product supply for the complex purified fish oil brand.
Generic versions of Amarin’s Vascepa (icosapent ethyl) in the US are expected to continue to face supply limits, despite stockpiles of generic product likely created prior to launch, according to the originator.
Hikma debuted “at-risk” the first Vascepa abbreviated new drug product in November last year, while Dr. Reddy's Laboratories...
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.
