BAJAJ BROKING

Notification
No new Notification messages
Denta Water & Infra Solutions IPO is Open!
Apply for the Denta Water & Infra Solutions IPO through UPI in just minutes.
Open a Free Demat Account
Pay ZERO maintenance charges for the first year, get free stock picks daily, and more.
Trade Now, Pay Later with up to 4x
Never miss a good trading opportunity due to low funds with our MTF feature.
Track Market Movers Instantly
Stay updated with real-time data. Get insights at your fingertips.

Laurus Labs’ US Arm Receives Form 483 from US FDA with One Observation

Synopsis:

Laurus Generics Inc., a subsidiary of Laurus Labs, received a Form 483 from the US FDA following a post-marketing inspection. Shares of Laurus Labs Ltd fell by 0.94%, closing at ₹571.45.

Laurus Generics Inc. news today

Laurus Labs Ltd announced that its wholly-owned subsidiary, Laurus Generics Inc. (LGI), based in Berkeley Heights, New Jersey, USA, has received a Form 483 from the US Food and Drug Administration (FDA). The Form 483, issued after a four-day post-marketing adverse drug experience (PADE) inspection from 13th to 21st January 2025, identified one observation regarding compliance practices. The company plans to address the observation within the stipulated timelines.

Also read: HUL Board Approves Demerger of Kwality Wall’s Ice Cream Business

LAURUS LABS LIMITED

Trade

585.1514.30 (2.50 %)

Updated - 23 January 2025
587.00day high
DAY HIGH
569.40day low
DAY LOW
1495768
VOLUME (BSE)

Key Takeaways

  • Inspection Duration: Conducted over four days (13th–21st January 2025).

  • Inspection Focus: PADE compliance practices for Laurus Labs’ marketed products.

  • Observation: One observation highlighted in Form 483.

  • Next Steps: Laurus Labs has 15 days to respond to the US FDA.

  • Impact on Shares: Laurus Labs Ltd share price dropped by 0.94% on the BSE.

Also read: BPCL Approves $121 Million Plan for Indonesia’s Nunukan Block

Details of the Inspection

The inspection scrutinised Laurus Generics Inc.’s adherence to US FDA standards for reporting adverse drug experiences. A Form 483 outlines areas of non-compliance observed during such inspections but does not indicate a final FDA determination. Companies are required to submit corrective action plans to the FDA within 15 days to address identified issues.

Compliance Observation Table

Aspect

Details

Facility Inspected

Laurus Generics Inc., New Jersey, USA

Inspection Type

Post-Marketing Adverse Drug Experience

Duration of Inspection

13th–21st January 2025

Form 483 Observations

One observation

Response Deadline

15 days from issuance

Market Reaction

Following the announcement, Laurus Labs Ltd share price closed at ₹571.45 on the BSE, reflecting a 0.94% dip. The share price movement indicates cautious investor sentiment as the company works to resolve the compliance issue.

While the issuance of a Form 483 marks a critical regulatory step, Laurus Labs Ltd remains committed to addressing the US FDA’s observation. The company’s timely response and corrective actions will be pivotal in ensuring compliance and maintaining global standards.

Also read: Paras Defence Signs ₹12,000 Crore MoU for Optics Park in Navi Mumbai

Do you have a trading account app or demat account app?

You can open an account with Bajaj Broking in minutes.

Download the Bajaj Broking app now from Play Store or App Store.

Disclaimer: Investments in the securities market are subject to market risk, read all related documents carefully before investing.

This content is for educational purposes only. Securities quoted are exemplary and not recommendatory.

For All Disclaimers Click Here: https://bit.ly/3Tcsfuc

Share this article: 

Read More Blogs

Our Secure Trading Platforms

Level up your stock market experience: Download the Bajaj Broking App for effortless investing and trading

Bajaj Broking App Download

8 Lacs+ Users

icon-with-text

4.4+ App Rating

icon-with-text

4 Languages

icon-with-text

₹5300+ Cr MTF Book

icon-with-text