Alembic Pharma bags USFDA approval for Paclitaxel Injection USP

27 Oct 2022 , 09:48 AM

Alembic Pharmaceuticals Limited announced that the US Food and Drug Administration (USFDA) has granted final approval for its Abbreviated New Drug Application (ANDA) for Paclitaxel Injection USP available in multiple-dose vials such as 30 mg/5 mL (6 mg/mL), 100 mg/16.7 mL (6 mg/mL), and 300 mg/50 mL (6 mg/mL).

This is the first oncology injectable product approval received by the company’s F-2 Facility (Oncology Injectable), which just passed its first USFDA inspection.

The authorised ANDA is therapeutically comparable to Taxol Injection, the reference listed drug product (RLD). Paclitaxel Injection, USP is authorised as a follow-up therapy for advanced ovarian cancer.

According to IQVIA, the market for Paclitaxel Injection USP is worth US$ 26 million in the twelve months ending June 2022.

Alembic has received 172 ANDA approvals from the USFDA (148 final approvals and 24 tentative clearances).

At around 9.51 AM, Alembic Pharmaceuticals was trading at Rs548.35 up by 0.04% from its previous closing of Rs548.15 on the BSE. The scrip opened at Rs551.25 and touched intraday high and low of Rs552.35 and Rs542.50 respectively.

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