Biocon’s Arm Gets Approval for Drug Used for Organ Transplant

Biocon Pharma, a wholly owned subsidiary of Biocon, received approval from China’s National Medical Products Administration (NMPA) for Tacrolimus capsules in 0.5mg, 1mg, and 5mg strengths. The immunosuppressant is used to prevent organ rejection in transplant patients, the company said in a press release on the stock exchange.

The approval enhances Biocon’s portfolio of complex drug products, with plans for swift commercialisation in the region, reflecting the company’s ongoing efforts to strengthen its global market presence.

Biocon’s API Facility Receives FDA VAI Status

A recent business development, Biocon received a Voluntary Action Indicated (VAI) status from the U.S. Food and Drug Administration (FDA) following a surveillance inspection conducted between September 16-20, 2024, at their API facility (Site 1) in Bengaluru, Karnataka.

The inspection is now officially closed. The company has confirmed that the report, along with further details, will be available on its official website. The VAI status indicates that while certain objectionable conditions were noted, the FDA is not recommending any regulatory action at this time.

Q2 FY25 Financial Highlights

Biocon reported a consolidated net loss of ₹16 crore for Q2FY25, in contrast to a net profit of ₹126 crore in the same period the previous year. Revenue from operations grew by 3.6% to ₹3,590 crore, driven by growth in the biosimilars segment.

However, the generics business faced pricing pressures and declining demand, while a planned shutdown of one of the API facilities impacted revenues.

Despite these challenges, Biocon’s management expressed optimism for a stronger second half of the fiscal year, with expectations of a turnaround, especially from the generics segment.

Share Price Performance

Biocon’s share price traded 0.27% lower at ₹372.25 at 9:35 AM on the NSE. The stock opened at ₹376.95 higher than ₹373.25 at its previous close.

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