Beximco Pharma gets US FDA approval

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).

The company has already submitted several Abbreviated New Drug Application (ANDAs) for the US market which are currently under review; export to US market will commence as soon as those ANDAs are approved. Nazmul Hassan, Managing Director of Beximco Pharma, said; “This is a remarkable achievement for the Bangladesh pharmaceutical industry as this makes ways for us to export medicines to the US market known for stringent regulations and quality standards.”

Beximco Pharma is a leading exporter of medicines in the country with its facilities already accredited by the regulatory authorities of European Union, Australia, Canada, Taiwan and Brazil, among others

Beximco Group

Taking Bangladesh to the World...

Today the BEXIMCO Group (“BEXIMCO” or the “Group”) is the largest private sector group in Bangladesh. BEXIMCO was founded in the 1970’s by two brothers – Ahmed Sohail Fasiur Rahman and Ahmed Salman Fazlur Rahman. Since the early days, the Group has evolved from being primarily a commodities trading company to a leading, diversified group with a presence in industry sectors that account for nearly 75% of Bangladesh’s GDP. BEXIMCO’s corporate mission is “Taking Bangladesh to the world”.

As BEXIMCO has grown over the years, the flagship platform now has operations and investments across a wide range of industries including textiles, trading, marine food, real estate development, hospitality, construction, information and communication technologies, media, ceramics, aviation, pharmaceuticals, financial services and energy. The Group sells its products and services in the domestic Bangladesh market as well as international markets. BEXIMCO is the largest employer in the private sector in Bangladesh and employs over 48,000 people worldwide.

The BEXIMCO name has now become one of the most recognizable brand names in Bangladesh. It is synonymous with innovation, trust and quality. The Group consists of four publicly traded and seventeen privately held companies. The publicly traded companies – Bangladesh Export Import Company Limited, Beximco Pharmaceuticals Limited, Shinepukur Ceramics Limited and Beximco Synthetics Limited – have a combined market capitalization of approximately $0.00 million. The Group had total revenues of $834 million in the year ended December 31, 2010.

BEXIMCO encompasses one of South Asia’s largest vertically integrated textile and garment companies. The Textile division is a fully integrated manufacturer of cotton and polyester blended garments for men, women and children, both for domestic and export markets. BEXIMCO is also the largest exporter of pharmaceuticals in Bangladesh with a presence in 45 countries. The Pharmaceuticals division manufactures and sells generic pharmaceutical formulation products, active pharmaceutical ingredients (API) and intravenous (IV) fluids. The Group is also the largest ceramics exporter and has an investment in GMG Airlines, the largest private commercial airline in Bangladesh and in Unique Hotels & Resorts, which owns the Westin Hotel in Bangladesh.

State-of-the-art manufacturing plants located in the vicinity of Dhaka provide the Group with a highly cost effective manufacturing base. A majority of its plants are in the BEXIMCO Industrial Park, a vertically integrated self-contained facility. This facility provides ready access to captive power generation, water purification, liquid nitrogen, waste water treatment and other key infrastructure. The Group’s global clients include some of the world’s best known brands including BT, BASF, Chevron, Calvin Klein, H&M, JC Penney, Macys, Zara, UNICEF, Royal Doulton and Villeroy & Boch.

BEXIMCO is well positioned to capitalize on strong growth across industries in both the domestic and global markets. Each Group company is managed by an independent, professional team with significant depth of experience. Management teams have established a clear strategic plan that will further strengthen the overall platform. BEXIMCO intends to leverage its market position and global scale, further diversify operations into highly profitable sectors, capitalize on the domestic growth opportunity and selectively pursue international opportunities going forward.

In recognition of its corporate success and creation of shareholder value, the BEXIMCO Group has and continues to make significant contributions to Bangladesh’s society. Sponsored organizations include “Proyash”, a specialized institute that works for the holistic development of children with special educational needs and “Gono Sahajjo Songstha”, an institution that provides education for the underprivileged. BEXIMCO was also an official sponsor of the Bangladesh National Cricket team for the ICC Cricket World Cup 2011 and also the official title sponsor of the FIFA friendly match between Argentina and Nigeria held in September, 2011.