Drug major Lupin on March 27 said the company has received European good manufacturing practice (EU GMP) certificate for its Mammalian facility in Pune where Etanercept biosimilar is intended to be manufactured. Biosimilar Etanercept is used to fight a range of severe auto-immune disorders.
“Etanercept is a complex product that requires a sophisticated development facility for production. The EU GMP certificate is a noteworthy achievement by the biotech manufacturing team,” Lupin Managing Director Nilesh Gupta said.
Gupta further said, “with this timely approval of our biotech facility we are well on track to start preparing for the manufacture and launch of our Etanercept Biosimilar for Europe.”
On March 26 Lupin’s Japanese subsidiary and YL Biologics had received an approval to manufacture and sell their biosimilar Etanercept in Japan.