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First Bangladeshi pharmaceutical company to launch pharmaceutical products in the US

Beximco Pharmaceuticals Limited (“BPL”, “Beximco Pharma” or “Company”; AIM Symbol: BXP), the fast-growing manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, today announces it has commenced the export of Carvedilol, a prescription drug for treating hypertension, to the US. This follows the product′s approval from the US Food and Drug Administration (“US FDA”) in November 2015 and is the first time a pharmaceutical product from Bangladesh has been launched in the US.

First time a Bangladeshi pharmaceutical company has launched pharmaceutical products in any gulf member country.

Beximco Pharmaceuticals Limited (“BPL”, “Beximco Pharma” or “Company”), the fast-growing manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, announces that it has commenced the export of pharmaceuticals to Kuwait.  This marks the first time a Bangladeshi pharmaceutical company has launched pharmaceutical products in any Gulf member country under the Gulf Cooperation Council (GCC).

Beximco Pharmaceuticals Limited has become the first Bangladeshi pharmaceutical company to receive approval for a prescription drug to be manufactured in this country for export to the USA. The Company says it has been granted formal approval from the U.S. Food and Drug Administration (“U.S. FDA”), following an extensive review of the submitted dossier and its manufacturing processes. This approval allows the Company to manufacture a popular blood pressure drug Carvedilol in different strengths (3.125 mg, 6.25 mg, 12.5 mg, and 25 mg) at the Company′s Tongi facility which recently achieved GMP approval from the US regulatory authority.

Beximco Pharmaceuticals Limited (“BPL”, “Beximco Pharma” or “Company”) becomes the first Bangladeshi pharmaceutical company to be approved by the U.S. Food and Drug Administration (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).

Beximco Pharmaceuticals Limited ("BPL" or "Company"; AIM Symbol: BXP), the fast-growing manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, today announces that it has become the first Bangladeshi pharmaceutical company to be audited by the US Food and Drug Administration (“FDA”) without any 483 observation.  A 483 form is issued when the US FDA has observations of non-compliance or deviation from its current Good Manufacturing Practices (“cGMP”).  The inspection of Beximco Pharma’s oral solid dosage manufacturing facility, in Tongi, took place during 19-22 January, 2015.

Country’s leading pharma manufacturer Beximco Pharmaceuticals Ltd makes a foray into Australian Pharma market with the launch of Pantoprazole, a drug for treating gastrointestinal disorder. This is for the first time pharmaceutical product from Bangladesh is being exported to Australia.

Beximco Pharmaceuticals Limited (“BPL” or “Company”; AIM Symbol: BXP), the fast-growing manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, today announces that it has received GMP (Good Manufacturing Practices) approval from the Canadian regulatory authority, Health Canada. Beximco Pharma is the first Bangladeshi company to receive GMP accreditation from Health Canada.

The US Ambassador to Bangladesh, His Excellency Dan W. Mozena, visited the state-of-the-art manufacturing facilities of Beximco Pharmaceuticals Ltd. (BPL) at Tongi on November 4, 2014 (Tuesday). He was accompanied by Daniel Keen, Economic Commercial Officer and other officials of the Embassy.

Beximco Pharmaceuticals Limited (“BPL” or “the Company”), the fast-growing manufacturer of generic pharmaceutical formulation products, active pharmaceutical ingredients and intravenous fluids, today announces that it has received GMP (“Good Manufacturing Practices”) accreditation from Taiwan Food and Drug Administration (TFDA) as the first Bangladeshi company. The company has received the approval for its oral solid, Inhaler and sterile eye drop facilities.

Mr. Mahbubul Alam, Independent Director of Beximco Pharmaceuticals Ltd., passed away on Friday 6th June, 2014. He had served as a Non-Executive Independent Director of the Company from March 2014. Additionally, he was the Chairman of the Audit Committee.