Aurobindo Pharma Arm Received a GMP Certificate From the European Medicines Agency

CuraTeQ Biologics Pvt. Ltd., a wholly-owned subsidiary of Aurobindo Pharma, has received a Good Manufacturing Practice (GMP) certificate of compliance from the European Medicines Agency (EMA). The certification is no small feat, it validates that the facility meets strict European standards for quality, safety, and efficacy.

The EMA inspection carried out from April 8 to April 12, 2024, gave a thorough check-up to various facility sections. From mammalian and microbial drug substance manufacturing to filling prefilled syringes and vials, packaging, and quality control labs, everything got scrutinized.

Opening to European Markets

This stamp of approval establishes the base for CuraTeQ’s three biosimilars awaiting European regulatory nods. The approvals are expected within the next two to five months, shared Satakarni Makkapati, Director of Aurobindo Pharma and CEO of Biologics, Vaccines, and Peptides.

With a pipeline of 14 biosimilars consisting of oncology and immunology, CuraTeQ has big plans. “We’re focused on building a sustainable portfolio and ensuring patients worldwide access to essential therapies,” said K. Nithyananda Reddy, Vice Chairman and Managing Director of Aurobindo Pharma.

Financials 

While this certification is a win, Aurobindo Pharma’s Q2FY25 numbers were a mixed bag. The company reported an 8% year-on-year jump in profit to Rs.817 crore. Sounds good? Not quite, analysts expected Rs.972 crore, so it fell short.

The shares of  Aurobindo Pharma Ltd. are currently trading at Rs.1258.55. Year-to-date, the stock is up 16.92% and has gained 29.37% over the last year. Analysts, though, seem optimistic, 20 out of 29 tracking the stock recommend a ‘buy,’ with an average 12-month target indicating a 22.5% potential upside.

Conclusion: All in all, the EU GMP certification puts CuraTeQ closer to making its mark in Europe’s biosimilar market. With approvals pending and demand growing, it’s a promising leap, though Aurobindo’s financials hint there’s more to prove.

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