Notification close image
No new Notification messages
card image
Seshaasai Technologies Ltd IPO
Apply for the Seshaasai Technologies Ltd IPO through UPI in Just minutes
delete image
card image
Start your SIP with just ₹100
Choose from 4,000+ Mutual Funds on Bajaj Broking
delete image
card image
Open a Free Demat Account
Pay ZERO maintenance charges for the first year, get free stock picks daily, and more.
delete image
card image
Trade Now, Pay Later with up to 4x
Never miss a good trading opportunity due to low funds with our MTF feature.
delete image
card image
Track Market Movers Instantly
Stay updated with real-time data. Get insights at your fingertips.
delete image

Unichem Labs USFDA Inspection at Kolhapur API Unit

Synopsis:


Unichem Laboratories Limited reported that a USFDA inspection at its Kolhapur API facility from 27 January to 2 February 2026 ended with five procedural observations, none linked to data integrity, as per NSE and BSE filings.


Source:
Unichem Laboratories Limited Press Release (NSE Exchange Filings) | Published on Feb 02, 2026

Disclaimer: This content has been published for informational purposes only. Bajaj Broking is not affiliated with, nor does it endorse or assume any responsibility for, the source material. Readers are advised to consult the original publication for complete and accurate context.

As quoted in the press release from Unichem Laboratories Limited (NSE Exchange Filings), the United States Food and Drug Administration inspected the company’s Kolhapur API facility. The inspection was carried out between 27 January 2026 and 2 February 2026.

The company informed the stock exchanges that the inspection ended with five observations. These observations were procedural in nature. The company also stated that none of the observations were linked to data integrity.

The disclosure was submitted to the National Stock Exchange of India and BSE Limited on 2 February 2026. The filing was made under Regulation 30 of the SEBI Listing Obligations and Disclosure Requirements Regulations, 2015.

Unichem Laboratories Limited stated that it will submit its responses to the USFDA within the stipulated 15-day period. The update was shared during market hours as part of regulatory disclosure requirements.

Unichem Laboratories Limited and share price activity reflected trading following the exchange filing.

Also Read: Brigade Hotel Ventures Commits ₹1100 Crore to Chennai Projects

 

Unichem Laboratories Ltd

Trade

410.635.25 (9.39 %)

Updated - 03 February 2026
416.00day high
DAY HIGH
380.00day low
DAY LOW
53382
VOLUME (BSE)

Key Takeaways

  • USFDA inspected the Kolhapur API facility

  • The inspection took place from 27 January to 2 February 2026

  • Five observations were issued after the inspection

  • The observations were procedural

  • No data integrity issues were reported

  • The company will respond within 15 days

USFDA Inspection at Kolhapur API Facility

The inspection was conducted at the Kolhapur unit. The facility is used for manufacturing active pharmaceutical ingredients.

The inspection lasted for six days. At the end of the process, the USFDA issued five observations.

The company clarified that these observations were procedural in nature. It also stated that none of the observations were related to data integrity.

The company confirmed that it will submit its responses within the required time frame. This information was shared through an exchange filing.

Regulatory Disclosure Details

The disclosure was addressed to both NSE and BSE. It was signed by the Head – Legal and Company Secretary of Unichem Laboratories Limited.

The filing was made for information and record purposes. No financial estimates or forward-looking statements were included.

The disclosure focused only on the inspection outcome and the response timeline.

Inspection Summary

Particulars

Details

Facility

Kolhapur API Facility

Inspecting Authority

United States Food and Drug Administration

Inspection Period

27 January to 2 February 2026

Observations Issued

Five

Nature Of Observations

Procedural

Data Integrity Issues

None

Response Timeline

Within 15 days

Unichem Laboratories Share Price Update

Unichem Laboratories Limited's share price data on the National Stock Exchange showed the stock trading at ₹377.95 as of 15:30 PM IST on 2 February 2026.

The share price rose by ₹2.55, or 0.68 per cent, from the previous close. The stock opened at ₹373.30 during the session.

The stock touched a high of ₹379.80 and a low of ₹365.05. The previous closing price was ₹375.40. Unichem Laboratories Limited's share price movement were tracked after the disclosure.

About Unichem Laboratories Limited

Unichem Laboratories Limited operates in the pharmaceutical sector. The company manufactures formulations and active pharmaceutical ingredients.

It has manufacturing facilities in India. The company supplies products to domestic and international markets, as stated in its regulatory filings.

Also Read: IRB Infrastructure Transfers VM7 Expressway to InvIT Fund

Published Date : 03 Feb 2026

Disclaimer :

The information on this website is provided on "AS IS" basis. Bajaj Broking (BFSL) does not warrant the accuracy of the information given herein, either expressly or impliedly, for any particular purpose and expressly disclaims any warranties of merchantability or suitability for any particular purpose. While BFSL strives to ensure accuracy, it does not guarantee the completeness, reliability, or timeliness of the information. Users are advised to independently verify details and stay updated with any changes.

The information provided on this website is for general informational purposes only and is subject to change without prior notice. BFSL shall not be responsible for any consequences arising from reliance on the information provided herein and shall not be held responsible for all or any actions that may subsequently result in any loss, damage and or liability. Interest rates, fees, and charges etc., are revised from time to time, for the latest details please refer to our Pricing page.

Neither the information, nor any opinion contained in this website constitutes a solicitation or offer by BFSL or its affiliates to buy or sell any securities, futures, options or other financial instruments or provide any investment advice or service.

BFSL is acting as distributor for non-broking products/ services such as IPO, Mutual Fund, Insurance, PMS, and NPS. These are not Exchange Traded Products. For more details on risk factors, terms and conditions please read the sales brochure carefully before investing.

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.

[ Read More ]

For more disclaimer, check here : https://www.bajajbroking.in/disclaimer

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

11 lakh+ Users

icon-with-text

4.8 App Rating

icon-with-text

4 Languages

icon-with-text

₹7,900+ Cr MTF Book

icon-with-text