Unichem Laboratories Ltd. announced that, its Goa facility (Plot No. 10 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa, India) received ‘Form 483’ with five observations. This is 1 of 2 USFDA approved facilities owned by the company. Unichem manufactures 33 of the total 58 formulation products manufactured for the US market. This facility manufactures Oral Solids.
The report analyses the impact of the observations on Unichem as well as competitors of products in its Goa Facility.