Gland Pharma Ltd. informed the exchanges on Tuesday that the company's Pashamylaram facility in Hyderabad has received an Establishment Inspection Report (EIR) from the USFDA, indicating closure of the inspection.
The inspection was conducted by the USFDA between June 15 and June 27, 2023 at the facility. The inspection pertained to seven products and Good Manufacturing Practices at the plant.
Gland Pharma's Pashamylaram unit had received two observations from the Office of Medical Device and Radiological Health Operations (OMDRHO) of the USFDA last month. Neither of those were data integrity operations.
The inspection for USFDA's quality systems, current good manufacturing practices for medical devices was carried out between August 23 - August 26, 2023.
Shares of Gland Pharma recovered from the day's low post the announcement and are currently trading with gains.
The stock of Gland Pharma is now trading with gains of over 55 percent in July-September quarter. This is the first quarter in seven, when the stock will have positive quarterly returns.
This will also be the company's best quarterly performance since it listed in early-2021. This quarter's returns will surpass the 38.2 percent that the stock had gained during the April-June quarter of 2021.
Gland Pharma shares recovered from the day's low and are currently trading 1.8 percent higher at Rs 1,689.45. The stock had crossed its IPO price of Rs 1,500 in mid-August and has been trading above those levels since then.
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