Gland Pharma Receives Two FDA Observations in Surprise Inspection

Gland Pharma Ltd. made an announcement on Thursday stating that from July 22 to July 25, the US Food and Drug Administration surprisedly inspected the company's Dundigal Facility in Hyderabad for compliance with good manufacturing practices.

Two 483 Observations were made at the end of the inspection, according to an exchange filing. The nature of these observations is procedural. Within the allotted time, the preventative and remedial measures for these observations will be submitted to the US FDA.

 According to the submission, they have nothing to do with data integrity or repeated observations.The provisional US FDA approval for Latanoprostene Bunod Ophthalmic Solution, 0.025% was given to the Hyderabad-based business on July 23. This eye drop helps individuals with glaucoma and ocular hypertension by lowering their increased intraocular pressure.