While the AAM is lobbying for a renewed focus on domestic drug production amid fresh concerns about the globalization of the US pharmaceutical drug supply chain, the association has urged US Congress to have confidence in FDA oversight, insisting that “the US has one of the safest drug supply chains in the world.”

The Alvogen group of companies has unveiled Adalvo as the new identity for its B2B business unit. In an exclusive interview, general manager Anil Okay talks to Generics Bulletin about the reasons behind the rebranding, what makes it unique in the B2B sphere, and the significance of 2023 for Adalvo’s strategy.

Zentiva is opening a dedicated Indian office in Mumbai to support the Ankleshwar manufacturing facility that it has just acquired from former parent company Sanofi.

The US FDA requests several manufacturers recall extended-release metformin based on studies confirming a higher NDMA impurity threshhold; previous testing found no significant risks.

After a tepid performance in the fiscal fourth quarter, Torrent expects its key markets India, US and Brazil to be impacted by the COVID-19 fallout as well as a lack of visibility on regulatory approvals for its manufacturing facilities.

Biocon is actively expanding its biosimilars manufacturing capacity with an aim to further penetrate EU markets after receiving a GMP approval for a key manufacturing site. The company has ramped up production for trastuzumab and pegfilgrastim, while awaiting approval for bevacizumab.