Cadila Healthcare completes USFDA inspection at Dabhasa facility
Cadila Healthcare Limited announced on Friday that the United States Food and Drug Administration (USFDA) has completed inspection at its Active Pharmaceutical Ingredients (API) manufacturing facility at Dabhasa.
The API manufacturing facility at Dabhasa is the group's largest API manufacturing site. Inspection was conducted from 7th to 11th October 2019. This was a CGMP audit and a pre-approval inspection (PAI). At the end of the inspection, no observation (483) is issued.
According to the 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.
Headquartered at Ahmedabad, Gujarat, Cadila Healthcare Ltd is one of the leading pharmaceutical companies in India. It is a major manufacturer of generic drugs. The group now has 273 approvals and has so far filed over 360 ANDAs since 2003-04.
On Friday, the shares of Cadila Healthcare Ltd. closed in BSE at Rs.230.10, down 0.86 per cent from its previous close of Rs. 232.10. The stock had opened at Rs. 234.95. It hit an intraday high of Rs. 234.95 and intraday low of 228.50. Its 52-week high stands at Rs. 387.50 and 52-week low is Rs. 206.45 on the BSE.