FARHAN FARDAUS and BABUL BARMAN | September 12, 2023 00:00:00
Beximco Pharmaceuticals faces a ban on export of eye drops for glaucoma to the European market over concerns tied to the manufacturing plant in Bangladesh.
The drug maker listed in Bangladesh's stock market and London Stock Exchange should be barred from supplying its timolol and latanoprost prescription eye drops to the European Union and European Economic Area "on the back of facility design concerns", as proposed by the Malta Medicines Authority (MMA) after an inspection.
A US-based news organisation -- Endpoints News ---published a report on Friday on the outcome of the inspection. Endpoints News is specialised in global biotech and pharmaceutical news.
The Malta Medicines Authority found one critical, three major and 15 other deficiencies after it conducted an inspection between July 28 and August 1 this year in Beximco Pharma's ophthalmic facility in Bangladesh.
The critical deficiency is related to the unit's Building Management System (BMS). The MMA filed its report with the European Union.
Endpoints News also says the facility's good manufacturing procedure (GMP) certificate will be withdrawn nearly two and a half years after it was issued to Beximco Pharma.
While talking to the FE over the phone, Mohammad Ali Nawaz, chief financial officer of Beximco Pharma, said the report was partially correct.
He, however, refused to speak further on the matter.
The company is yet to post any explanation on the Dhaka Stock Exchange on the issue but gave a clarification on the London Stock Exchange on Monday.
In the clarification, the drug maker said the company at present was not exporting ophthalmic products from the manufacturing unit to the European Union or to the European Economic Area.
The MMA proposed that the European Union prohibits the company from exporting the products to the EU or EEA, but the proposal has not been ratified by the EU, according to the clarification. However, the company has continued to supply these products to other markets where approvals have been received.
In absence of a Building Management System that enables integrated and automated centralised monitoring, the company is using alternative means to monitor the facility, the company said in the clarification.
Total sales of products from the ophthalmic manufacturing unit constituted less than 1 per cent of group sales reported for FY22.
"Beximco Pharma is working closely with the Malta Medicines Authority to implement remedies," said the drug manufacturer, which would include the installation of a new building management system ahead of another audit by the Malta Medicines Authority expected in early 2024.
It noted that the inspection findings are not applicable to the company's other manufacturing units.
"The cost of implementing the remedies will not have a material financial impact on the company's performance for the current financial year," reads the clarification.
Beximco Pharma, a major drug manufacturer in Bangladesh, exports drugs to more than 50 countries, including the highly regulated markets of the USA, Europe, Canada and Australia.
The drug maker was listed in the Bangladesh stock market in 1986 while in the London Stock Exchange in 2006.
Its stock price has been stuck at the floor price of Tk 146.20 since February this year on the Dhaka Stock Exchange. On the London Stock Exchange, its stock traded at 38.50 GBX (penny sterling) on Monday 30 minutes before closing.
After the clarification, the stock rose 2.67 per cent from the previous day on the London Stock Exchange.
Beximco Pharma's sales revenue rose almost 18 per cent year-on-year to Tk 34.67 billion in FY22. More than 8 per cent of the revenue came from exports.
However, the drug maker's profit slid 2.70 per cent to Tk 4.99 billion in FY22. The company paid 35 per cent cash dividend.
Profit fell due to price hike of raw materials caused by the dollar crisis and an increase in foreign exchange losses on imports, said the company in its earnings note.
The company's revenue in July-March of FY23 grew almost 13 per cent year-on-year to Tk 29.23 billion but profit dropped 15 per cent to Tk 3.56 billion.
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