REG - Beximco Pharma. - Clarification on Press Report

Beximco PharmaceuticalsAnnouncement

11/09/2023 10:30

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RNS Number : 0201M  Beximco Pharmaceuticals Ltd  11 September 2023

 

11 September 2023

 

BEXIMCO PHARMACEUTICALS LTD.

 

Clarification on Press Report

 

Beximco Pharmaceuticals Limited ("Beximco Pharma", "BPL" or "the Company"; AIM
Symbol: BXP, LEI No.: 213800IMBBD6TIOQGB56), the fast-growing manufacturer of
generic pharmaceutical products and active pharmaceutical ingredients, notes a
recent press report discussing certain findings from a planned Good
Manufacturing Procedure (GMP) inspection of the Company's ophthalmic
manufacturing unit that took place between 28 July and 1 August 2023 by The
Malta Medicines Authority (MMA). This manufacturing facility had previously
received GMP certification from other EU Member States.

 

As noted in the press report, the inspection audit cites one Critical Issue,
three Major Deficiencies and a number of other Deficiencies. The Critical
Deficiency finding relates to the Unit's Building Management System (BMS). The
report has been filed with the European Union (EU). As further clarification
to the press report, it should be noted that (i) the Company does not
currently export ophthalmic products from this manufacturing unit to the EU or
to the European Economic Area (EEA); (ii) while the MMA has proposed that the
EU prohibits the Company from exporting these products to the EU or EEA , this
proposal has not yet been ratified by the EU and; (iii) the Company continues
to supply these products to other markets where approvals have been received;
(iv) in absence of integrated and automated centralised monitoring by a BMS,
the Company is using alternative means to monitor the facility environment
data. Total sales of products from the ophthalmic manufacturing unit
constituted <1% of Group sales for the Company's last reported financial
year (12 months ending 30 June 2022).

 

The Company is working closely with the MMA to implement remedies to all
observations cited in the report in a timely manner, including the
installation of a new BMS system, ahead of another audit by the MMA expected
in early 2024. The inspection findings are not pertinent 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.

 

 

 

For further information please visit www.beximcopharma.com or enquire to:

 

Beximco Pharma

Nazmul Hassan MP, Managing Director

Tel: +880 2 58611001, Ext.20080

S M Rabbur Reza, Chief Operating Officer

Tel: +880 2 58611001, Ext.20111

 

Mohammad Ali Nawaz, Chief Financial Officer

Tel: +880 2 58611001, Ext.20030

 

SPARK Advisory Partners Limited (Nominated Adviser)

Mark Brady / Andrew Emmott

Tel: +44 (0) 20 3368 3551 / 3555

 

SP Angel Corporate Finance LLP (Broker)

Vadim Alexandre / Abigail Wayne

Tel: +44 (0) 20 3470 0470

 

FTI Consulting

Simon Conway / Victoria Foster Mitchell/ Sam Purewal

Tel: +44 (0) 20 3727 1000

 

 

 

Notes to Editors

 

About Beximco Pharmaceuticals Limited

 

Beximco Pharma is a leading manufacturer and exporter of medicines based in
Bangladesh. Since its inception in 1976, the Company remains committed to
health and wellbeing of people across all the continents by providing access
to contemporary medicines. Company's broad portfolio of generics encompasses
diverse delivery systems such as tablets, capsules, liquids, semi-solids,
intravenous fluids, metered dose inhalers, dry powder inhalers, sterile
ophthalmic drops, insulins, prefilled syringes, injectables, nebuliser
solutions, oral soluble films etc. The Company also undertakes contract
manufacturing for multinational and leading global generic pharmaceutical
companies.

 

Beximco Pharma′s state-of-the-art manufacturing facilities are certified by
global regulatory authorities of USA, Europe, Australia, Canada, GCC and Latin
America, among others and it has a geographic footprint in more than 50
countries. More than 5,500 employees are driving the company towards achieving
its aspiration to be among the most admired companies in the world.

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