BAJAJ BROKING

Notification
No new Notification messages
Sat Kartar Shopping IPO is Open!
Apply for the Sat Kartar Shopping 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.

Biocon Biologics’ Johor Bahru Facility Receives FDA VAI Classification

Listen to our Podcast: Grow your wealth and keep it secure.

0:00 / 0:00

Synopsis:

The U.S. FDA classified Biocon Biologics’ Johor Bahru insulin facilities as Voluntary Action Indicated (VAI) after inspecting multiple biologics manufacturing and quality control units in September 2024.

Biocon Biologics news today

Biocon Biologics’ insulin manufacturing facilities in Johor Bahru, Malaysia, have been classified as Voluntary Action Indicated (VAI) by the U.S. Food and Drug Administration (FDA). The classification follows a comprehensive cGMP inspection conducted between 15 and 27 September 2024. The inspection covered multiple biologics manufacturing units, including a Drug Substance unit, Drug Product unit, Medical Device Assembly unit, Analytical Quality Control Laboratory, two Microbiological Control Laboratories, and two Warehouses.

Also read: JSW Energy Completes ₹630 Crore Acquisition of 125 MW RE Assets

BIOCON LIMITED.

Trade

375.114.14 (3.91 %)

Updated - 13 January 2025
376.95day high
DAY HIGH
364.10day low
DAY LOW
2223573
VOLUME (BSE)

Key Takeaways:

  • FDA conducted a cGMP inspection of Biocon Biologics facilities in September 2024.

  • Inspection scope included eight manufacturing and quality control units.

  • Facilities classified as Voluntary Action Indicated (VAI).

Also read: DMart Appoints Anshul Asawa as CEO Designate, Succeeding Ignatius Noronha

Overview of inspected units

The FDA’s inspection included a thorough evaluation of Biocon Biologics’ key manufacturing and quality control facilities.

Unit Inspected

Function

Drug Substance Unit

Produces active ingredients for insulin

Drug Product Unit

Manufactures final insulin formulations

Medical Device Assembly Unit

Assembles insulin delivery devices

Analytical Quality Control Laboratory

Ensures product quality and compliance

Microbiological Control Laboratories

Conduct microbiological testing

Warehouses

Store raw materials and finished products

Impact on Biocon Biologics’ operations

The VAI classification indicates that while certain observations were made, no critical violations requiring mandatory action were identified. This recognition further solidifies Biocon Biologics’ commitment to maintaining global quality and compliance standards.

The FDA’s VAI classification for Biocon Biologics’ Johor Bahru facilities reflects the company’s consistent adherence to cGMP guidelines. This development may positively influence the Biocon Biologics share price as the company continues its focus on quality manufacturing for global markets.

Also read: Interarch Secures ₹221 Crore Projects in Semiconductors & Energy Storage

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