Shares of Alembic Pharmaceuticals soared nearly 5 percent on October 9 after the drugmaker's oncology formulation facility in Panelav, Gujarat cleared the US Food and Drug Administration's inspections without any observations.
The USFDA had inspected the facility on October 7 and 8. Following the regulatory clearance of the unit, shares of Alembic Pharma opened on a positive note and extended gains to hit its record high of Rs 1,303.90 before some profit booking pulled its off its peak. At 11.46 am, shares of Alembic Pharma were trading at Rs 1,260.90 on the NSE.
The uptick in the stock was also triggered by a sharp spike in trading volumes. As much as six lakh shares changed hands on the exchanges so far, higher than the one-month daily traded average of five lakh shares.
Earlier this month, the drugmaker received the final approval from the USFDA for its anti-seizure drug Lamotrigine, which happens to be the generic version of GlaxoSmithKline's Lamictal XR.
According to IQVIA, the estimated market value for Lamotrigine is around $163 million for the year ending June 2024. With this, Alembic Pharma now has a total of 216 ANDA (Abbreviated New Drug Application) approvals from the USFDA, which includes 188 final approvals and 28 tentative approvals.
Last month, brokerage firm HSBC also upgraded Alembic Pharmaceuticals shares to 'hold' and raised its target price by 12 percent to Rs 1,130. The brokerage believes that Alembic's enhanced US regulatory filings and expanding portfolio of differentiated products could support long-term sales growth in the US. However, HSBC also highlighted that strong execution will remain essential for Alembic to achieve a substantial increase in US sales.
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