Gland Pharma’s Hyderabad Facility Gets Two US FDA Observations
The two observations received were neither repeated nor related to data integrity, the company said.
Gland Pharma Ltd. announced on Thursday that the United States Food and Drug Administration conducted surprise inspection on the company’s Dundigal Facility at Hyderabad for Good Manufacturing Practices between July 22 to July 25. The inspection was concluded with two 483 Observations, as per an exchange filing.
These observations are procedural in nature. The corrective and preventive actions for these observations will be submitted to the US FDA within the stipulated period. They are neither repeated observations nor related to data integrity, the filing said.
On July 23, the Hyderabad-based company received tentative US FDA approval for Latanoprostene Bunod Ophthalmic Solution, 0.025%. This eye drop is used to reduce elevated intraocular pressure in glaucoma and ocular hypertension patients.
Gland Pharma Ltd. stock rose as much as 0.71% during the day to Rs 2,033.85 apiece, compared to a 0.13% decline in the benchmark NSE as of 1:50 p.m.
