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
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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.
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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
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.
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.
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 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.
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.
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