Eskayef Pharmaceuticals Becomes Third Bangladeshi Company to Receive US FDA Approval for Manufacturing Facility
Key Insights
Eskayef Pharmaceuticals Ltd (search) received US FDA approval for its solid manufacturing facility in Tongi, Gazipur, becoming the third Bangladeshi pharmaceutical company to achieve this milestone after Square (search) and Beximco Pharma (search).
The approval enables Eskayef to export Pregabalin capsules in eight different strengths (25mg to 300mg) to the US market, with the anti-epileptic and neuropathic pain (search) medication set to launch shortly.
This achievement follows more than five years of efforts and represents a significant step toward Bangladesh's pharmaceutical export growth, which reached $169 million in 2020-21, more than doubling from $83 million five years earlier.
The US Food and Drug Administration (search) has approved Eskayef Pharmaceuticals Ltd (search)'s solid manufacturing facility, marking a significant milestone that positions the Bangladeshi company to enter the world's largest pharmaceutical market. The approval covers the company's Faraaz Ayaaz Hossain Building (FAHB) facility located in Tongi, Gazipur.
Pregabalin Market Entry
Eskayef submitted an Abbreviated New Drug Application (ANDA) for Pregabalin capsules across eight different strengths: 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, and 300mg. Pregabalin is an anti-epileptic drug that also serves to control neuropathic pain (search). The company plans to launch this product in the US market shortly following the approval.
"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 (search) and managing director and CEO of Eskayef Pharmaceuticals Ltd (search).
Strategic Market Position
This FDA approval represents the culmination of more than five years of dedicated efforts by Eskayef. The company joins Square (search) and Beximco Pharma (search) as the third pharmaceutical manufacturer from Bangladesh to receive US FDA approval among nearly 200 pharmaceutical companies operating in the country.
Rahman emphasized the strategic importance of this achievement: "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."
Global Regulatory Recognition
The FDA approval adds to Eskayef's existing portfolio of international regulatory approvals. The company's manufacturing sites have previously received approvals from the United Kingdom Medicines and Healthcare Products Regulatory Agency (UK MHRA), European Union Good Manufacturing Practice (EU GMP), Veterinary Medicines Directorate (VMD) of UK, Brazil Agencia Nacional de Vigilancia Sanitaria (Brazil ANVISA), and Therapeutic Goods Administration (TGA) of Australia.
COVID-19 Innovation Leadership
During the COVID-19 (search) pandemic, Eskayef demonstrated its innovation capabilities by launching several world-first generic medications. The company introduced 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 under the brand name Paxovir.
Industry Impact and Export Growth
The approval carries significant implications for Bangladesh's pharmaceutical export sector. The country posted export earnings of $169 million from pharmaceutical shipments in the 2020-21 fiscal year, representing more than double the $83 million recorded five years earlier. During the current fiscal year, drug exports have shown continued strength, with manufacturers including Eskayef logging 21 percent higher year-on-year export receipts to $130 million in the July-February period.
Professor ABM Faroque, former dean of Faculty of Pharmacy at the University of Dhaha, highlighted the broader significance: "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."
Quality Standards Validation
The FDA approval process requires manufacturers to prove that their products are "safe and effective." As Professor Md Mustafizur Rahman from Khulna University's Life Science School explained, "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."
Company Background
Eskayef Pharmaceuticals Limited operates as part of the Transcom group, founded by the late Latifur Rahman, who received the Oslo Business for Peace Award in 2012. The company has been producing medicines for 32 years and currently exports to 67 countries across six continents. Eskayef manufactures and markets a wide range of therapeutic drugs, bulk pellets, and animal health and nutrition products, having started its journey in 1990 when Bangladesh's operation of SK&F, USA was acquired by Transcom Group.