Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance and drug product manufacturing facility located in Hyderabad, India. As part of the established approval process,
the CHMP positive opinion will now be reviewed by the European Commission (EC), following which a decision will be made on the grant of marketing authorisation in the European Union (EU) member
countries, and the European Economic Area (EEA) member states of Norway, Iceland, and Liechtenstein. A Marketing Authorisation Application (MAA) for submission to the UK Medicines and Healthcare products
Regulatory Agency (MHRA) will be made separately in keeping with the reliance route under the International Recognition Procedure (IRP).
