Ajanta Pharma Dahej facility concludes USFDA inspection with no Form 483

Published On 2023-06-26 05:38 GMT | Update On 2023-06-26 05:38 GMT

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.

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.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Ajanta Pharma Dahej facility concludes USFDA inspection with no Form 483

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