The US Food and Drug Administration has given approval to a facility of Eskayef Pharmaceuticals Ltd, an achievement that would allow the company to enter the world’s largest drug market.
The company said in a press release yesterday that the US FDA gave approval to Eskayef’s solid manufacturing facility of the Faraaz Ayaaz Hossain Building (FAHB) located in Tongi, Gazipur.
Eskayef submitted Abbreviated New Drug Application (ANDA) for Pregabalin capsules in eight different strengths — 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg.
The approval will allow Eskayef to export solid pharmaceutical products, including Pregabalin, from the facility to the US market.
Pregabalin is an anti-epileptic drug, which is also used to control neuropathic pain. Eskayef, the third drug manufacturer from Bangladesh to get the US FDA approval, will launch the product in the US shortly.
Eskayef’s manufacturing sites have earlier received approvals from other global regulatory authorities.
These are United Kingdom Medicines and Healthcare Products Regulatory Agency (UK MHRA), European Union (EU) Good Manufacturing Practice (GMP), Veterinary Medicines Directorate (VMD) of UK, Brazil Agencia Nacional de Vigilancia Sanitaria (Brazil ANVISA) and Therapeutic Goods Administration (TGA) of Australia.
“Unwavering commitment to quality has always been at the forefront of Eskayef’s drive to serving humanity, and receiving this accreditation from the US FDA has solidified our hold as the epitome of quality products for the people of Bangladesh and the world,” said Simeen Rahman, group CEO of Transcom Limited and managing director and CEO of Eskayef Pharmaceuticals Ltd.
“It is a moment of great pride and a significant move towards our long-term strategy of stepping into the US market. In this journey, we have the aspiration to focus on technology-driven molecules and complex products in the pipeline to address unmet patient needs, where I believe the talented individuals at Eskayef will differentiate us from others,” she said.During the ravages of the Covid-19 pandemic, Eskayef launched the world’s first generic Remdesivir brand Remivir, first generic Molnupiravir brand Monuvir and first generic version of Nirmatrelvir tablets co-packaged with Ritonavir tablets with the brand name Paxovir, it said.
SIGNIFICANCE OF US FDA APPROVAL
Of nearly 200 pharmaceuticals companies operating in Bangladesh, Eskayef has won the US FDA approval after Square and Beximco Pharma.
The approval from one of the toughest regulators will enable Eskayef to export drugs to the US market as it depicts a high quality.
The US FDA issues export certificates for approved or licenced drugs and for unapproved drugs that meet certain legal requirements.
The approval of FDA is important, because it validates the need for research on how drugs work on patients. In order to receive FDA approval for a drug or a medical device, the manufacturer must prove to the FDA that the item is “safe and effective”.
Officials said Eskayef got the approval following more than five years of efforts.
The recognition will play a big role in further accelerating export of drugs made in Bangladesh, the country which posted export earnings of $169 million from pharmaceuticals shipment in the 2020-21 fiscal year, more than twice the overall receipts of $83 million five years ago.
During the current fiscal year, drug exports have been buoyant. Manufacturers, including Eskayef, logged 21 percent higher year-on-year export receipts to $130 million in the July-February period of the current fiscal year.
“This is really a matter of great pride. This shows that some of our manufacturers are making drugs maintaining international quality. Such recognition is also testament to the fact that we have very efficient human resources like pharmacists to make world-class drugs,” said Professor ABM Faroque, former dean of Faculty of Pharmacy at the University of Dhaka.
Congratulating Eskayef, he said, “We want to see them getting approval for more and more drugs from US FDA in the coming days.”
Professor Faroque suggested local drug makers who got FDA approval to be cautious and maintain high standards so that more drugs from Bangladesh get approval from the US FDA, the strictest drug regulator in the world.
Md Mustafizur Rahman, professor of pharmacy discipline of the Life Science School at Khulna University, said the US FDA approval for a company means that its production processes has reached US standards.
“This approval helps companies export its products to the US market and the US importers do not remain uncertain about the quality of the products. Additionally, Regulators of other countries take the approval without any question, which is an honour for any company,” he noted.
Eskayef Pharma is one of the organisations of Transcom group founded by Late Latifur Rahman, who was awarded with Oslo Business for Peace Award in 2012, the highest distinction given to a businessperson for outstanding accomplishments in the area of ethical business.
Eskayef has been producing medicines for 32 years and currently exporting to 67 countries across six continents.
The drug maker, which manufactures and markets a wide range of therapeutic drugs, bulk pellets, and animal health and nutrition products, started its journey in 1990, when Bangladesh’s operation of SK&F, USA was acquired by Transcom Group.
Source: The Daily Star
