Global CDMO Enzene has received European Union (EU) GMP certification for its two facilities in Pune, India.
The sites offer both microbial and mammalian commercial-scale drug substance manufacturing and drug product fill/finish services.
Both of the Indian sites were assessed by the European Medicines Agency (EMA), who determined that they met the quality and safety standards enforced by the regulatory body.
This approval enforces Enzene's ability to address the needs of its European customers in the biopharmaceutical space, while also strengthening India's position in the biologics manufacturing space.
“The European Union’s GMP certification provides existing and potential customers with tangible evidence that Enzene meets the stringent quality and safety standards required by the European Medicines Agency," said an Enzene spokesperson.
"These certifications mark another step on Enzene's journey to providing comprehensive solutions to clients in Europe and beyond."
Enzene's Pune site was the first site in the company's network to feature Enzene's modular EnzeneX 2.0 platform, which reduces equipment footprint.
The platform can produce a clinical phase cGMP batch at the 30 L scale, with variable bioreactor capacity allowing for scale-on and scale-out expansion.
According to the company, it will also soon inaugurate its $50m US manufacturing facility in Hopewell, New Jersey — which will expand the company's footprint into the US.