Beximco Pharmaceuticals Ltd US FDA approves Metformin for diabetes control (1709S)
December 19 2016 - 2:00AM
UK Regulatory
TIDMBXP
RNS Number : 1709S
Beximco Pharmaceuticals Ltd
19 December 2016
19 December 2016
BEXIMCO PHARMACEUTICALS LIMITED
US FDA approves extended-release Metformin for diabetes
control
Third product approval for the US market
Beximco Pharmaceuticals Limited ("Beximco Pharma" or "the
Company"; AIM Symbol: BXP), the fast-growing manufacturer of
generic pharmaceutical products and active pharmaceutical
ingredients, and Bangladesh's leading exporter of pharmaceutical
products, today announces that it has received approval for its
Metformin Hydrochloride extended-release tablets (500 mg and 750
mg) from the US Food and Drug Administration (US FDA). This product
is the generic equivalent to Bristol-Myers Squibb's (BMS)
Glucophage XR tablets (500 mg and 750 mg).
Metformin is indicated as an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes mellitus.
Annual sales for Glucophage XR in the US were $918 million for the
twelve months ending 31 October 2016, according to IMS data. This
is Beximco's third Abbreviated New Drug Application (ANDA) approval
since the Company's oral solid dosage facility was approved by the
US FDA in June 2015.
Nazmul Hassan MP, Managing Director of Beximco Pharmaceuticals
Limited, commented:
"This marks our third US FDA product approval since November
last year and clearly demonstrates our competitive in-house
expertise, in particular, our strength in extended-release
formulation. We expect to launch this product through our US
distribution partner during the middle of 2017."
Beximco Pharma became the first Bangladeshi pharmaceutical
company audited and approved by the US FDA in June 2015 and also
the first in the country to export medicine to US.
For further information please visit www.beximcopharma.com or
enquire to:
Beximco Pharma
Nazmul Hassan MP, Managing Director
Tel: +880 2 58611001, ext.20080
SPARK Advisory Partners Limited (Nominated Adviser)
Mark Brady / Sean Wyndham-Quin
Tel: +44 (0)20 3368 3551 / 3555
Daniel Stewart & Company plc (Broker)
David Lawman / Daphne Zhang
Tel: 020 7776 6550
FTI Consulting
Simon Conway / Victoria Foster Mitchell
Tel: +44 (0)20 3727 1000
Notes to Editors
About Beximco Pharmaceuticals Limited
Founded in 1976 and based in Dhaka, Bangladesh, Beximco Pharma
manufactures and sells generic pharmaceutical formulation products
and active pharmaceutical ingredients. The Company also undertakes
contract manufacturing for multinational and leading global generic
pharmaceutical companies. The Company operates from a 23 acre site
in Dhaka and has manufacturing facilities for producing various
drugs in different delivery systems such as tablets, capsules,
liquids, semi-solids, intravenous fluids, metered dose inhalers,
dry powder inhalers, sterile ophthalmic drops, prefilled syringes,
injectables, nebuliser solutions, oral soluble films etc. Ensuring
access to quality medicines is the powerful aspiration that
motivates 3,500 employees of the Company.
Beximco Pharma's state-of-the-art manufacturing facilities are
certified by global regulatory authorities of the US, Europe,
Australia, Canada, GCC and Latin America, among others. The
Company's products are sold to retail outlets, medical institutions
and other pharmaceutical manufacturers in Bangladesh, in regional
markets such as Sri Lanka, Nepal, Bhutan, Vietnam, Cambodia and
Myanmar and in other markets overseas, principally in South East
Asia, including Singapore, Taiwan, Malaysia, Indonesia, Philippines
and Hong Kong; Africa, including South Africa, Mauritius, Kenya,
Ghana, Ethiopia, Uganda and Nigeria; Central Asia, including
Azerbaijan; Middle East, including Kuwait and Jordan; Pacific
Island countries; Latin and Central American countries; Europe,
including Austria, Germany and Romania; Australia and the US.
This information is provided by RNS
The company news service from the London Stock Exchange
END
MSCLFFILFFLTLIR
(END) Dow Jones Newswires
December 19, 2016 02:00 ET (07:00 GMT)
Beximco Pharma (LSE:BXP)
Historical Stock Chart
From Apr 2024 to May 2024
Beximco Pharma (LSE:BXP)
Historical Stock Chart
From May 2023 to May 2024