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Gland Pharma’s USFDA Telangana Unit Inspection Ends with 2 Observations

Jul 25, 2024

By: BlinkX Research Team

Gland Pharma on Thursday, July 25, announced that the United States Food and Drug Administration (USFDA) has concluded its inspection at the former's Telangana facility.

Key Takeaways from Gland Pharma’s USFDA Inspection

• Gland Pharma announced that the United States Food and Drug Administration (USFDA) has concluded its inspection at the former's Telangana facility.
• The Hyderabad-based company commented that the USFDA issued Form 483 with two observations.
•  The observations according to the company are procedural.

In a stock exchange filing, the company said the US drug regulator carried out a surprise inspection at its Dundigal facility in Hyderabad, focusing on compliance with good manufacturing practices (GMP). The inspection was conducted between July 22 to July 25, 2024.

The Hyderabad-based company added that the US FDA issued Form 483 with two observations. The company said that these observations are procedural. ‘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,’ Gland Pharma commented.

Gland Pharma reported a 56% year-on-year (YoY) rise in sales at Rs 5,665 crore in FY24, owing to a combination of new product launches, and relaunches, and maintained market leadership for its existing medicines. Despite the revenue growth, the company's net profit dipped by 1% to Rs 772 crore.

About Gland Pharma Limited

Gland Pharma, founded in 1978 in Hyderabad, India, has grown from a contract manufacturer of small-volume liquid parenteral products to one of the largest and fastest-growing injectable-focused companies in the world, with a presence in 60 countries including the United States, Europe, Canada, Australia, India, and others.

The company typically works on a business-to-business (B2B) basis and has a great track record of developing, manufacturing, and marketing complex injectables. This presence across the value chain has allowed it to experience exponential development. Shanghai Fosun Pharma, a leading worldwide pharmaceutical company, is promoting the company.

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