Alembic Pharmaceuticals Share Price in Focus; US FDA Issues Form 483 With No Observations for Bioequivalence Unit in Gujarat

Alembic Pharmaceuticals has announced that its Bioequivalence Facility in Vadodara, Gujarat, has completed an unannounced onsite inspection by the United States Food and Drug Administration (US FDA), according to an exchange filing dated September 11, 2026. 

Inspection Dates 

The US FDA inspection was carried out from August 31, 2026, to September 10, 2026. It was conducted at the company’s Bioequivalence Facility in Vadodara and was an unannounced visit. 

The inspection therefore covered 11 calendar days. The company’s filing focused on the inspection and its outcome. 

No Form 483 Observations 

The company noted that there were no Form 483 observations following the inspection. It did not list any deficiencies or other observations from the US FDA in the filing. 

The filing also did not give details of the areas examined during the inspection or provide any other findings from the US FDA. The company only reported the completion of the inspection and the absence of Form 483 observations. 

Facility In Gujarat 

The inspection was specifically carried out at Alembic Pharmaceuticals’ Bioequivalence Facility in Vadodara, Gujarat. The company referred to it as an onsite Bioequivalence inspection conducted by the US FDA. 

The visit started on 31 August and concluded on 10 September. No separate observations were reported by the company in its 11 September exchange filing. 

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Alembic Pharmaceuticals Share Price Performance  

As of September 11, 2026, 2:00 pm, Alembic Pharmaceuticals share price was trading at ₹811.40, down 0.61% from the previous closing price. 

Conclusion 

Alembic Pharmaceuticals’ Bioequivalence Facility in Vadodara underwent an unannounced US FDA inspection over 11 days. The company reported no Form 483 observations. 

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