Aurobindo Pharma Limited on Tuesday announced that its wholly owned subsidiary CuraTeQ Biologics Private Limited has received a GMP certificate of compliance for its biosimilars manufacturing facility from the EMA.
According to the company’s statement, the GMP inspection, conducted by EMA representatives from April 8th to April 12th, 2024, assessed mammalian and microbial drug substance manufacturing facility sections, prefilled syringes and vials filling, packaging, and QC testing and release laboratories.
“The EU GMP certification marks a significant milestone in CuraTeQ’s commitment to manufacturing high-quality biosimilars for patients worldwide. This inspection outcome paves way for securing approvals for our three biosimilars in Europe, currently under review by the Agency, within the next two to five months,” Dr. Satakarni Makkapati, Director of Aurobindo Pharma Limited and CEO of Biologics, Vaccines, and Peptides, said.
CuraTeQ Biologics Private Limited (CuraTeQ), a subsidiary of Aurobindo Pharma Limited, is a global biopharmaceutical company headquartered in Hyderabad, India. CuraTeQ’s vision is to improve the wellbeing of patients suffering from debilitating illnesses by providing them access to high quality and cost-effective biosimilars.
It is focused on developing biosimilars for the treatment of various cancers and autoimmune diseases. CuraTeQ’s pipeline consists of fourteen biosimilars, primarily targeting the immunology and oncology segments.
“Our portfolio comprises fourteen biosimilars in development across oncology and immunology segments. We are dedicated to building a sustainable biosimilars portfolio and bringing these essential therapies to patients,” K. Nithyananda Reddy, Vice-Chairman and Managing Director of Aurobindo Pharma Limited, said.
The company has has end-to-end capabilities in producing a full range of products from bulk drug substance to fill-finish and packaged drug products, it added.
Article reposted from Financial Express.
