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Gland Pharma Shares Slip 2% as USFDA Issued 2 Observations 

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

Shares of Gland Pharma Ltd slipped 2% and hit an intra-day low of Rs 1,978.40 on 25 July after the company announced that the US Food and Drug Administration (USFDA) had completed its inspection of its Telangana facility.

The business said in a stock exchange announcement that the US pharmaceuticals authority had conducted a surprise inspection of its Dundigal facility, located close to Hyderabad, with an emphasis on good manufacturing procedures (GMP). The investigation took place between 22 July 2024 and 25 July 2024.

After the inspection, the USFDA issued a Form 483 with two observations. According to the company, this is merely a procedural observation. 

The company, in its filing, added, “The corrective and preventive actions for these observations will be submitted to the USFDA within the stipulated period. The observations issued are neither repeated observations nor related to data integrity.”

Earlier last month, the company announced the appointment of Srinivas Sadu as executive chairman and CEO of Gland Pharma. Sadu has more than 20 years of experience, the company said in a stock exchange statement. Since 25 April 2019, he has served as both the company’s managing director and CEO.

Furthermore, in May 2024, Gland Pharma announced its first-ever equity dividend since going public in 2020. The company proposed a dividend of ₹20 per share, amounting to an outflow of ₹329 crore, which represents a dividend payout ratio of 43%. The record date for this dividend payout is set for 16 August, pending shareholder approval. This milestone reflects a significant step in Gland Pharma’s financial strategy.

Gland Pharma saw a 56% YoY rise in sales in FY24, reaching Rs 5,665 crore, which was driven by a combination of relaunches, new product releases, and the current brands’ continued dominance in the market. 

At 3:30 pm, Gland Pharma’s shares closed 0.87% lower at Rs 2,002 on NSE.

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