Tue Feb 25 12:46:37 UTC 2025: ## Gland Pharma Receives Minor FDA Observations

**Visakhapatnam, India (February 26, 2025)** – Gland Pharma, a leading generic injectable manufacturer, announced that its Visakhapatnam facility received three observations from the U.S. Food and Drug Administration (FDA) following a recent pre-approval inspection. The inspection, conducted from February 19th to 25th, focused on sterile active pharmaceutical ingredients (APIs).

The company stated that the observations are procedural in nature and not related to data integrity or previous findings. Gland Pharma plans to submit corrective and preventive actions to the FDA within the required timeframe. The company did not specify the nature of the observations.

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