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Caplin Point Tamil Nadu Unit Passes FDA Inspection with Zero 483 Observations

Synopsis:

Caplin Point Laboratories’ Gummidipoondi unit passed the US FDA inspection with zero 483 observations. The inspection focused on Good Manufacturing Practices, enhancing Caplin Point Laboratories Ltd share price prospects.

Caplin Point Laboratories' news today

Caplin Point Laboratories Ltd has announced a significant regulatory milestone. Its Gummidipoondi-based sterile injectable and ophthalmic manufacturing facility received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA). The unannounced inspection, conducted from 5 to 9 August 2024, concluded with zero 483 observations. This outcome demonstrates Caplin Point’s robust adherence to Good Manufacturing Practices (GMP) and other regulatory standards, further strengthening its reputation in the pharmaceutical industry.

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CAPLIN POINT LAB LTD.

Trade

1878.99.90 (0.52 %)

Updated - 30 April 2025
1926.00day high
DAY HIGH
1846.10day low
DAY LOW
124384
VOLUME (BSE)

Key Takeaways

  • Inspection Dates: 5–9 August 2024

  • Facility Location: Gummidipoondi, Tamil Nadu

  • Inspection Outcome: Zero 483 observations

  • Report Status: Establishment Inspection Report (EIR) issued

  • Regulatory Focus: Good Manufacturing Practices compliance

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FDA Inspection Details

The inspection was a routine regulatory check to assess the facility’s compliance with FDA regulations, including GMP. The zero 483 observations highlight the company’s dedication to maintaining high manufacturing standards. Caplin Steriles, a subsidiary of Caplin Point Laboratories Ltd, oversees the production of injectable and ophthalmic products at this unit, ensuring quality consistency for global markets.

Caplin Point Laboratories Ltd Share Price Update

Following the announcement, Caplin Point Laboratories Ltd share price closed at ₹2,521.05, marking a decline of ₹15.45 or 0.61% on the Bombay Stock Exchange (BSE). Despite this minor dip, the successful FDA inspection positions the company well for sustained growth in international markets.

Details

Data

Inspection Dates

5–9 August 2024

Facility Location

Gummidipoondi, Tamil Nadu

FDA Report Received

6 January 2025

Observations

Zero 483 observations

Caplin Point Laboratories Ltd Share Price

₹2,521.05

Caplin Point’s successful FDA inspection underscores its commitment to regulatory excellence and high-quality manufacturing. This development strengthens its market presence and potential to capture international opportunities.

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