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Generic drug player Beximco Pharma

Beximco Pharma, is a generic drug player committed to providing access to affordable medicines. It's state-of-the-art manufacturing facilities have been accredited by the regulatory authorities of USA, Australia, European Union, Canada, and Brazil, among others, and it currently focuses on building presence in many emerging and developed markets around the world. The company received US Food and Drug Administration (FDA) approval for flecainide acetate 50mg, 100mg and 150mg tablets. The company announced this last week. Flecainide acetate is the generic equivalent to 3M Pharmaceuticals' 'Tambocor'.

Beximco Pharma was founded in 1976 and started operations in 1980, manufacturing products under the licenses of Bayer AG of Germany and Upjohn Inc. of United States. Today Beximco Pharma manufactures and markets its own branded generics for several diseases including AIDS, cancer, asthma, hypertension, and diabetes for both national and international markets. It was the first drug company from Bangladesh to sell its products in the US. In May 2020, the company introduced world’s first generic Remdesivir for Covid-19 treatment.

The company is consistently building upon its portfolio and currently producing more than 500 products encompassing broad therapeutic categories and the Company has created strong differentiation by offering a range of high-tech, specialized products which are difficult to imitate. The main manufacturing site is spread across a 22-acre area located near the capital city, Dhaka, which houses facilities for manufacturing tablets, capsules, intravenous fluids, liquids, creams, ointments, suppositories, metered dose inhalers, ophthalmic drops, large volume parenterals, sterile ophthalmics, prefilled syringes, lyophilized injectables etc. The site has its own utility infrastructure to ensure adequate generation and distribution of electricity with an installed capacity of 10 MW, besides having water purifying and liquid nitrogen generation facilities. Our penicillin units are located separately at Kaliakoir, 21 km from the main site. The company expected to launch the product through its US distribution partner in due course. Beximco noted that, according to IQVIA audited market data, the total addressable market for flecainide acetate was approximately $50m annually. Managing Director of Beximco Pharma Nazmul Hassan said in a statement that 'This approval is another important step in building and strengthening our presence in the US market'.

The company has a three-tier management structure, comprising the Board of Directors, the Executive Committee and the Management Committee. There is also an Audit Committee, constituted in 2006. The Board is the highest level of authority within the Company comprising mainly non-executive directors, none of whom receive directors' remuneration from it. The Board meets with the Executive Committee, comprising six executive directors, twice a year to conduct a full review of the Company's operations.

Flecainide acetate is an antiarrhythmic drug, used for treating irregular heartbeats in conditions such as tachycardia and atrial fibrillation. It was Beximco Pharma's eighth abbreviated new drug application (ANDA) successfully approved for the US market since its oral solid dosage facility was approved by the FDA in June 2015.




 

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