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Gland Pharma Shares Tumble 2% as Vizag Plant Gets USFDA EIR

After the inspection, the USFDA issued a Form 483 with two observations.

The shares of Gland Pharma were trading in the red and 2% lower on 8 November after the company announced that its manufacturing facility in Visakhapatnam, Andhra Pradesh, has received an EIR (Establishment Inspection Report) from the USFDA (US Food and Drug Administration).

The EIR report signifies the end of the inspection and allows the company to go ahead and file for drug applications.

A Good Manufacturing Practice inspection was conducted between 20-28 July by the US regulator at the company’s VSEZ Sterile Oncology Facility at Visakhapatnam.

On 6 November, the company announced its quarterly earnings for the July-September quarter. The company reported a 19.56% year-on-year (YoY) decline in its net profit at Rs 194 crore from Rs 241.2 crore reported in the same quarter last year.

The company’s revenue from the quarter saw a 31.52% YoY increase to Rs 1,373.4 crore during the quarter from Rs 1,044.4 crore reported in the year-ago quarter.

The company’s EBITDA (earnings before interest, taxes, depreciation and amortisation) for the quarter came in at Rs 320.5 crore against Rs 297 crore reported in Q2FY23.

Mr. Srinivas Sadu, MD & CEO of Gland Pharma, said, “Pricing and market share trends have shown encouraging indicators of normalisation in our key products, contributing to our revenue growth. The overall business stability is restoring confidence, and we stay optimistic about future growth with the forthcoming launches, portfolio expansion, and entry into new markets via a partner-led strategy.”

At 3:30 pm, the shares of Gland Pharma closed 1.70% lower at Rs 1,625 on NSE.

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