We wish to inform you that the formulations facility in Bangalore recently underwent pre- approval product inspection by the USFDA. The inspection ended on August 25, 2018 and the company has been issued a Form 483 with 3 observations. The Company believes that the observations are not material in nature and we have already responded to the USFDA.
The Company has recently (post completion of the inspection) received a product approval for Potassium Chloride Extended Release Tablets from this facility.
You are requested to take the same on record.
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