Ajanta Pharma Dahej facility gets 2 procedural observations from USFDA
The formulation facility was inspected by USFDA from 5th September 2022 to 9th September 2022.
Mumbai: Ajanta Pharma has recently announced that the US Food and Drug Administration (USFDA) has concluded the inspection with 2 procedural observations at the company's formulation facility situated at Dahej.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
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The formulation facility was inspected by USFDA from 5th September 2022 to 9th September 2022.
"At the end of the inspection, Form 483 was issued to us with 2 procedural observations. We are in the process of responding to the same within the stipulated time prescribed by USFDA," the company stated in a recent BSE filing.
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Ajanta Pharma is a specialty pharmaceutical company engaged in the development, manufacturing, and marketing of quality finished dosages. The company's business includes Branded Generics in emerging markets of Asia and Africa, Generics in the developed markets of the USA, and Institution sales. In India, the company has a presence in high-growth specialty segments of cardiology, dermatology, ophthalmology, and pain management.
Ajanta operates 7 state-of-the-art manufacturing facilities in India. 2 of the facilities in India have been successfully approved by US FDA.
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