Gland Pharma Gains as USFDA Completes Pre-Approval Inspection at Visakhapatnam Facility

Gland Pharma’s stock surged on the BSE, following the successful conclusion of a Pre-Approval Inspection (PAI) by the United States Food and Drug Administration (USFDA) at its Visakhapatnam facility. The stock is currently trading at ₹1,616.15, up by ₹20.65 or 1.29%, compared to its previous closing price of ₹1,595.50.

Gland Pharma
Gland Pharma

Stock Performance Overview

  • Opening Price: ₹1,604.85
  • Day’s High: ₹1,649.95
  • Day’s Low: ₹1,587.10
  • 52-Week High: ₹2,220.95 (August 6, 2024)
  • 52-Week Low: ₹1,412.00 (February 12, 2025)
  • One-Week High/Low: ₹1,649.95 / ₹1,473.45
  • Market Capitalization: ₹26,989.63 crore

The promoters hold a 51.83% stake in the company, while institutions and non-institutions hold 39.84% and 8.33%, respectively.

USFDA Inspection Details

The USFDA conducted the Pre-Approval Inspection (PAI) for Sterile Active Pharmaceutical Ingredients (APIs) at Gland Pharma’s JNPC, Visakhapatnam facility between February 19 and February 25, 2025.

The inspection concluded with three Form 483 observations, which the company stated were procedural in nature. Gland Pharma confirmed that the observations are neither repeat violations nor related to data integrity. The company is set to submit its corrective and preventive actions to the USFDA within the stipulated timeframe.

Company Outlook

Gland Pharma is a leading developer, manufacturer, and marketer of complex injectables, primarily operating under a business-to-business (B2B) model across multiple global markets. The positive outcome of the USFDA inspection reinforces the company’s regulatory compliance and operational stability, which could boost investor confidence moving forward.

BREAKING NEWS:
Get 365-day plans under ₹2000 before price hike! IPL 2026: Vaibhav Sooryavanshi Leads in Sixes! Rajasthan Royals lose despite Sooryavanshi’s fiery innings: Key culprits!