USFDA issues 3 observations to Gland Pharma Hyderabad Unit, stock down 6%

The inspection at the Hyderabad facility took place between July 25, 2024 and August 02, 2024.

Gland Pharma stock falls: Shares of Gland Pharma plunged as much 6 per cent to hit an intraday low of Rs 2,000.05 per share on Monday, August 05, 2024.

However, at 11:14 AM, shares of the company were trading 1.75 per cent lower at Rs 2,090.60 per share. In comparison, BSE Sensex was trading 2.60 per cent lower at 78,876.80 levels.

The fall in the stock price came after the United States Food and Drug Administration (USFDA) issued 3 observations for the company’s Hyderabad facility. 

In an exchange filing, Gland Pharma said, “This is to inform you that the United States Food and Drug Administration (US FDA) has conducted an un-announced inspection of the Company’s Pashamylaram Facility at Hyderabad for Good Manufacturing Practices (GMP) between July 25, 2024 and August 02, 2024.” 

The inspection took place between July 25, 2024 and August 02, 2024. 

According to Gland Pharma, the inspection was concluded with three 483 observations, which are procedural in nature. The observations issued are neither repeated observations nor related to data integrity, it added.

The corrective and preventive actions for these observations will be submitted to the USFDA within the stipulated period, the company said. 

Founded in Hyderabad, India in 1978, Gland Pharma has evolved from a contract manufacturer specialising in small volume liquid parenteral products into one of the largest and fastest-growing companies in the generic injectables industry. Today, Gland Pharma has a robust global presence across 60 countries, including the United States, Europe, Canada, Australia, and India.

Operating primarily on a business-to-business (B2B) model, Gland Pharma boasts an impressive track record in pharmaceutical research and development, manufacturing, and marketing of complex injectables. 

The company's expertise spans sterile injectables, oncology, and ophthalmic segments, with a focus on complex injectables such as New Chemical Entities (NCE-1s), First-to-File products, and 505(b)(2) filings.

Gland Pharma's product range includes liquid vials, lyophilised vials, pre-filled syringes, ampoules, bags, and drops. The company is also expanding its capabilities to include complex injectables like peptides, long-acting injectables, suspensions, and hormonal products. Additionally, Gland Pharma is working to incorporate new delivery systems, such as pens and cartridges, into its diverse product portfolio.

The market capitalisation of the company is Rs 34.443 crore, according to Bombay Stock Exchange (BSE). The company falls under the BSE 200 category.