Last Updated on October 14, 2024 by The Health Master
The formulation facility at Dahej in Gujarat was inspected by the US Food and Drugs Administration (USFDA) team between June 19-23, 2023.
At the end of the inspection, no Form 483 was issued to us, the company said in a disclosure to the stock exchanges.
According to the USFDA website, Form 483 is issued to a company after the conclusion of an inspection when the investigator observed that any food, drug, or device has been adulterated or held under conditions whereby it may become injurious to health.
In September 2022, the USFDA inspected Ajanta Pharma‘s Dahej facility and issued two observations on that particular plant that manufactures formulations.
Exports constitute around 30 percent of Ajanta Pharma’s business and within the export markets the US contributes nearly 30 percent total sales in foreign countries.
Ajanta Pharma is a specialty pharmaceutical company providing quality medicines across more than 30 countries across the world. It enjoys leadership in multiple molecules and therapeutic segments.
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