Gland Pharma faces FDA inspection, gets 3 observations

5 Aug 2024 , 11:20 AM

The US Food and Drug Administration (US FDA) conducted an unannounced inspection of Gland Pharma Ltd’s Pashamylaram facility in Hyderabad. The inspection took place from July 25, 2024, to August 2, 2024, to evaluate Good Manufacturing Practices (GMP).

The inspection concluded with three 483 observations. Gland Pharma clarified that these observations are procedural and not related to data integrity or repeat issues. The company will submit corrective and preventive actions to the US FDA within the stipulated period.

At the time of writing on August 05, 2024 at 11:10 am, shares of Gland Pharma Ltd is trading at ₹2078 which is a 2.26% dip than the previous close. Gland Pharma Ltd shares has witnessed a 54% gain in the last one year, and 9% gain since the beginning of the year.

Gland Pharma was established in Hyderabad, India, in 1978. Initially, it served as a contract manufacturer of small volume liquid parenteral products.

The company has grown to become one of the largest and fastest-growing generic injectables manufacturing companies. Gland Pharma has a global footprint across 60 countries, including the US, Europe, Canada, Australia, India, and others.

The company operates primarily under a business-to-business (B2B) model. Gland Pharma has a strong track record in pharmaceutical research and development, manufacturing, and marketing of complex injectables.

Shanghai Fosun Pharma, a global pharmaceutical major, is one of its promoters. The company specializes in sterile injectables, oncology, and ophthalmic segments. It focuses on complex injectables, including NCE-1s, First-to-File products, and 505(b)(2) filings.

Products are delivered via liquid vials, lyophilized vials, pre-filled syringes, ampoules, bags, and drops. Efforts are underway to enhance manufacturing capabilities for peptides, long-acting injectables, suspensions, and hormonal products.

The company is also working on new delivery systems such as pens and cartridges. Gland Pharma is committed to meeting diverse injectable needs with high-quality products at attractive price points.

The company leverages R&D expertise in synthesizing complex molecules to produce complex injectables. Gland Pharma successfully develops niche products for diverse markets worldwide.