Cadila Healthcare receives EIR for Baddi facility from USFDA
An Establishment Inspection Report (EIR) from U.S. Food and Drug Administration (USFDA) has been received by Cadila Healthcare's manufacturing facility at Baddi, India, classifying the facility as 'No Action Indicated (NAI)'.
An inspection by USFDA had been conducted at the facility from March 02 to March 09, 2020, which ended with nil observations.
USFDA had granted tentative approval to Zydus Cadila, earlier this month, to market Droxidopa Capsules in the strengths of 100 mg, 200 mg, and 300 mg. Droxidopa treats symptoms of low blood pressure when standing (orthostatic hypotension), such as dizziness and light-headedness, caused by a specific medical condition.
Since the commencement of the filing process in FY 2003-04, the group now has 290 approvals and has filed over 386 Abbreviated New Drug Applications (ANDA).
Cadila Healthcare is a technology-driven, research-oriented pharma company having operations like human formulations, diagnostics, veterinary formulations and bulk drugs, skin care products, herbal products and OTC products.
Cadila Healthcare's stock rallied 3.5 per cent to Rs 349.70 in the early morning session on Friday, from its previous close of Rs 338.05.