Alembic Pharmaceuticals shares slipped as much as 2% on Tuesday, 14 July, touching a day low of Rs 814.55 on the NSE.

The fall came after the company disclosed a USFDA warning letter tied to its Vadodara bioequivalence facility. The letter is dated 10 July, 2026. Alembic said it became aware of the communication on 12 July.

According to the company, the warning letter relates to a clinical investigator involved in a bioequivalence study at the Vadodara site. It follows a USFDA inspection carried out at the facility between 3 and 7 March, 2025.

Alembic clarified that the observations concern the Informed Consent Form used during the study. The company also said these observations are not related to data integrity.

Based on its initial assessment, Alembic said the warning letter does not restrict operations at the bioequivalence facility. The company does not expect any material financial impact at this stage either.

It added that it is now working closely with the clinical investigator. The goal is to prepare a response for the USFDA within the prescribed timeline.

A clinical investigator oversees a research study from start to finish. Their job includes preparing the study protocol, monitoring participant safety, and reporting results once the trial wraps up.

Coming to the stock price, shares were trading at Rs 824.05 on the NSE at 13:16 pm. That’s down 0.84% from Monday’s close of Rs 831.05.

The stock touched an intraday high of Rs 834.75 earlier in the session before slipping into negative territory. Alembic Pharma is down 20.04% over the past year and remains well off its 52 week high of Rs 1,044.80.

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