The Irish drug regulator said that Lupin’s facility met its good manufacturing practices guidelines. It also said that the inspection, conducted virtually due to the ongoing pandemic, was limited to pre-fill packaging work.
The certification allows Lupin’s Pune facility to export pre-fill packaged etanercept injection pens to the Irish shores for the next three years. Ireland’s affiliation to the European Medicines Agency also means that pre-filled injections from the Pune unit can be marketed in other EU countries.
Lupin’s Pune facility is known for its R&D and manufacturing work related to biosimilars. The facility had helped develop Lupin’s etanercept biosimilar, which has been approved by the drug regulators of Japan and the European Union.
The company had set up the R&D unit in 2008 under the arm Lupin Biotech for the development, manufacturing and pre-clinical studies to clinical programs in biotech products required for approval in both regulated as well as semi-regulated markets, according to the company’s website.
