Ajanta Pharma Dahej facility concludes USFDA inspection with no Form 483
Mumbai: Ajanta Pharma has recently announced that the US Food and Drug Administration (USFDA) has concluded an inspection at the Company's Dahej facility with no Form 483.
The USFDA inspected the facility from 19th June 2023 to 23rd June 2023.
"This is to inform you that our formulation facility at Dahej was inspected by US FDA from 19th June 2023 to 23rd June 2023. At the end of inspection, no Form 483 was issued to us," the company informed in a BSE filing.
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.
Medical Dialogues team had earlier reported that the USFDA had concluded the inspection with 2 procedural observations at the company's formulation facility situated at Dahej.
Read also: Ajanta Pharma Dahej facility gets 2 procedural observations from USFDA
Mumbai-based Ajanta Pharma is a speciality pharmaceutical formulation company. Ajanta Pharma operates 7 state-of-the-art manufacturing facilities in India. Out of this, 6 facilities manufacture finished formulations and 1 manufactures Active Pharmaceutical Ingredients (APIs), primarily for captive consumption. Stringent authorities like the US FDA and WHO have approved the company's facilities at Paithan in Maharashtra and Dahej in Gujarat. The company's business includes Branded Generics in India and Emerging Markets of Asia and Africa; Generics in USA; and Institution Sales in Africa.
Read also: Ajanta Pharma gets CDSCO Panel Nod to manufacture, market high blood pressure FDC drug
