Square Pharma fulfills FDA\\\'s standard

US FDA (United States Food and Drug Administration) has recently released Establishment Inspection Report (EIR) on recent Pre Approval Inspection (PAI ) to Square Pharmaceuticals Ltd.
The report states that Square had a satisfactory cGMP inspection covering manufacturing of solid dosage form. Square has taken necessary preparations to manufacture launched quantity of the product, according to a statement.
For the first time in Bangladesh US FDA conducted cGMP (Current Good Manufacturing Practices) audit of Bangladesh Pharmaceutical manufacturing facilities in January 2015. 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 USA. 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 agencies like UK and Australia," the statement added.
Meanwhile, Beximco Pharmaceuticals Limited became the first Bangladeshi pharmaceutical company to be approved by the US FDA following successful inspection of its oral solid dosage facility at Tongi, during January 19-22, 2015.
The company says it has received the establishment inspection report (EIR) from the US drug regulatory authority stating that the audit is formally concluded.
This is a major milestone for the company as well as for the entire industry as this is the first time a Bangladeshi company has received the prestigious FDA approval.
This approval is based on the comprehensive audit encompassing all the systems of drug manufacturing: Quality; Facilities and Equipment; Materials; Production; Packaging and Labeling; and Laboratory Controls.  Remarkably, there was no 483 observation issued by the US regulatory authority. A 483 form is issued when FDA has observations of non-compliance or deviation from Good Manufacturing Practices (GMP).
The company has already submitted several Abbreviated New Drug Application (ANDAs) for the US market which are currently under review; export to US market will commence as soon as those ANDAs are approved.
Nazmul Hassan, Managing Director of Beximco Pharma, said;"This is a remarkable achievement for the Bangladesh pharmaceutical industry as this makes ways for us to export medicines to the US market known for stringent regulations and quality standards."
Beximco Pharma is a leading exporter of medicines in the country with its facilities already accredited by the regulatory authorities of European Union, Australia, Canada, Taiwan and Brazil, among others.