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The certification came after a successful inspection by the Finnish Medicines Agency on behalf of EMA from March 10 to March 14, 2025
The partnership will work on a new biological entity (NBE) in the immuno-oncology field to better treat cancer.
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No regulatory issues were raised by the USFDA at Unit-2 during the inspection, the company said in a regulatory filing.
Shilpa Medicare said it has completed Phase 3 trials for SMLNUD07 – Nor Ursodeoxycholic Acid (Nor UDCA) tablets in 165 NAFLD patients in India.
The certification followed a successful inspection by the European Medicines Agency, Austria, held from September 24 to September 26 at the Nacharam, Hyderabad facility.
This FDA approval is a milestone in cancer therapy as it presents a more convenient and precise alternative to the traditional tablet forms.
Shilpa Medicare is the first Indian company to gain approval for Phase III trials of Recombinant Human Albumin.
The European Directorate for the Quality of Medicines & Healthcare (EDQM) gave Shilpa Pharma Lifesciences, the company's subsidiary, the Certificate of Suitability (CEP) for Nifedipine.
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