Beximco Pharmaceuticals Ltd FDA approves Beximco Pharma Methocarbamol tablets (9421L)
25 July 2017 - 4:00PM
UK Regulatory
TIDMBXP
RNS Number : 9421L
Beximco Pharmaceuticals Ltd
25 July 2017
25 July 2017
BEXIMCO PHARMACEUTICALS LTD.
US FDA approves Beximco Pharma's muscle relaxant Methocarbamol
tablets
Fourth 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, today announces that it has received approval for its
Methocarbamol tablets (500 mg and 750 mg) from the US Food and Drug
Administration (US FDA). This product is a generic equivalent to
the muscle relaxant Robaxin tablets (500 mg and 750 mg), produced
by Auxilium Pharmaceutcials, LLC, for pain relief associated with
acute musculoskeletal conditions.
This is Beximco Pharma's fourth Abbreviated New Drug Application
(ANDA) successfully approved for the US market since the Company's
oral solid dosage facility was approved by the US FDA in June 2015.
Beximco Pharma expects to launch the product through its US
distribution partner during the last quarter of 2017. According to
IMS data, the estimated market for Methocarbamol tablets in the US
is approximately $30 million.
Mr. Nazmul Hassan MP, Managing Director of Beximco
Pharmaceuticals, commented:
"We are delighted to have received our fourth product approval,
within two years, from the US FDA. I firmly believe our US product
approvals to date, along with our growing pipeline, will help us to
continue to build our presence in this important market. We remain
focused on our strategic goal to bring high quality, differentiated
products to emerging and developed markets to create value for all
our customers and shareholders."
Beximco Pharma became the first Bangladeshi pharmaceutical
company audited and approved by the US FDA in June 2015. The
Company currently has a global footprint in more than 50 countries
and has been accredited by a number of global regulatory
authorities, including US FDA, AGES (EU), TGA Australia, Health
Canada, GCC and TFDA.
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
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 USA, 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
REAMMGZNVDMGNZM
(END) Dow Jones Newswires
July 25, 2017 02:00 ET (06:00 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