logo

Square Pharma audited by US FDA

Friday, 6 February 2015



For the first time in Bangladesh US FDA (United States Food and Drug Administration) conducted cGMP (Current Good Manufacturing Practices) audit of Bangladesh Pharmaceutical manufacturing facilities in January 2015. Square Pharmaceuticals Ltd, the leading Bangladesh Pharmaceutical company, was audited on this occasion. US FDA audit is considered to be most rigorous among all the Pharmaceutical cGMP inspections of the developed countries. USFDA also audited facility of Beximco Pharma in the same occasion, said a statement.
Manufacturing and Quality Assurance system of the oral solid dosage facilities of Square Pharma located at Gazipur was audited in accordance with the Code of Federal Regulations (21 CFR : Food & Drugs) of United Stated of America. The audit ended without issuing any 483 form. Square Pharma facilities have the track record of complying with the most stringent cGMP audits of highly regulated markets like UK and Australia.