Aurobindo Pharma Ltd. announced on Tuesday that its subsidiary has received final approval from the United States Food and Drug Administration for the Plerixafor Injection.

Share Market Live

NSE

The pharmaceutical company’s wholly-owned subsidiary, Eugia Pharma has been awarded the final approval for manufacturing and marketing Plerixafor Injection in a 24 mg/1.2 mL (20 mg/mL) dosage for mobilizing hematopoietic stem cells (HSCs), by the USFDA, Aurobindo Pharma said in a filing to the stock exchanges.

Plerixafor injection is recommended in the mobilisation of HSCs and is used in combination with granulocyte-colony stimulating factor (G-CSF), for collecting and subsequently autologous transplantation in patients having multiple myeloma or non-Hodgkin’s lymphoma.

The health regulator has granted the final approval to Eugia Pharma’s Plerixafor Injection, which is a single-dose vial and is not only bioequivalent but also therapeutically equivalent to the reference listed drug (RLD), Mozobil Injection, 24 mg/1.2 mL (20 mg/mL) of Genzyme Corporation.

As per IQVIA MAT data for the twelve months ending May 2023, the Plerixafor Injection had garnered annual sales of $210 million.

The USFDA approval marks the 163rd Abbreviated New Drug Applications (ANDA), including eight a total of eight tentative approvals received out of Eugia Pharma Speciality Group (EPSG) facilities. This includes the manufacture of both oral as well as sterile specialty products.

Shares of Aurobindo Pharma are trading 0.3 percent higher at Rs 787.25.