Express (July 21, 2011)
Beximco Pharmaceuticals Limited, the fast-growing manufacturer of generic pharmaceutical formulation products, active pharmaceutical ingredients and intravenous fluids, Wednesday announced that it has received GMP ("Good Manufacturing Practices") accreditation from the Regulatory Authority of Austria for its oral solid (tablets and capsules) and sterile eye drop facilities at Tongi, Dhaka.
The approval received from the Austrian Drug Authority will be recognized throughout the European Union (EU) by Mutual Recognition between the member countries. This is a significant milestone for the company which should facilitate exports to the lucrative generic drug markets of Europe.
"We are very pleased to reach such an important milestone with the EU approval," said Nazmul Hassan, Managing Director of Beximco Pharma. "This approval is a testimony to the high standards of quality and compliance practices put in place by the Company. This is an important step towards our aspiration to become a global generic drug player, and particularly for building our presence in the regulated markets of US and EU."
Beximco Pharma is currently exporting to many countries around the world and its state-of-the-art manufacturing facilities have already received approvals from global regulatory authorities including TGA (Australia), GCC (Gulf), ANVISA (Brazil) and INVIMA (Colombia).
The Company has recently entered the US pharma market through the acquisition of an Abbreviated New Drug Application (ANDA) of a cardiovascular drug. Two products have already been filed for marketing approval in the EU, while a number of products are in the pipeline.
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