Beximco Pharmaceuticals Ltd Clarification on Press Report (0201M)
11 Settembre 2023 - 11:17AM
UK Regulatory
TIDMBXP
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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END
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September 11, 2023 05:17 ET (09:17 GMT)
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