Beximco to start drug exports to US in Aug
Beximco Pharmaceuticals is set to make its debut in the US, one of the highly regulated drug markets in the world -- an achievement that is expected to take Bangladesh's medicine industry to a new height.
This is the first time that a drug made in Bangladesh will be sold in the US market.
“This is a major milestone for us and for the industry,” Shawkat Haider, head of business development of Beximco Pharma, told The Daily Star.
The company, which received the approval from the US's Food and Drug Administration last year, will make the first shipment of the blood pressure prescription drug Carvedilol in the first week of August, he said.
Prior to giving the authorisation, the FDA inspected the facilities of Beximco Pharma and Square Pharma and gave its seal of approval.
Now, some other local drug markers are working to get the FDA approval.
The development comes at a time when the pharmaceutical industry is looking to accelerate the export of generic drugs by taking advantage of the World Trade Organisation's patent waiver facility for least-developed countries until January 2033.
Bangladesh's pharmaceutical industry, which meets 97 percent of the domestic requirements, has so far shipped generic drugs to nearly 100 markets.
Of the countries, 50 regularly import drugs from Bangladesh, according to industry insiders.
Export earnings increased 13 percent year-on-year to $82 million in fiscal 2015-16, according to the Export Promotion Bureau. In fiscal 2009-10, total earnings from pharmaceutical exports were only $41 million.
Haider declined to share the value of the first shipment to the US, which accounts for one-third of the $1 trillion global pharmaceutical market.
Total spending on medicines in the US reached $310 billion in 2015 on an estimated net price basis, up 8.5 percent from the previous year, according to the IMS Institute for Healthcare Informatics.
The annual generic drug market in the US stands at $70-80 billion, Haider said, adding that the entry into the US market will open doors to other countries.
“This recognition implies that we can make quality medicine. As FDA recognition is one of the highest recognition, there will be no questions about the quality of our product.”
Beximco, which exported $15 million worth of medicines in fiscal 2015-16, sent its maiden shipments to Kuwait and Australia this year. Prior to the FDA recognition, Beximco, one of the top five local companies, received approval from the regulatory authorities of the US, European Union, Australia, Canada and Brazil for its facilities.
Haider said the Indian firms will be the main competitors of Bangladesh in the US market.
Asian countries, particularly Myanmar and Nepal, are the biggest market for locally manufactured drugs, followed by Africa and Europe, according to the Beximco official.
To promote pharmaceutical sector, the government also set up an active pharmaceutical ingredients industrial park, which will allow the industry to produce raw materials on a large scale.