Last checked at 24 Apr 2019 07:00
24 April 2019
BEXIMCO PHARMACEUTICALS LTD.
Beximco Pharma receives US FDA approval for Cyproheptadine
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, today announces it has received US Food and Drug Administration (FDA) approval for anti-allergy drug Cyproheptadine Hydrochloride Tablet (4 mg), which is a generic equivalent to Periactin® Tablets (4 mg) from Merck and Company, Inc. Cyproheptadine is an antihistamine used to relieve allergy symptoms such as hives, watery eyes, sneezing and itchy eyes or nose. The total US market for Cyproheptadine tablets was approximately $16 million in 2018.1
In August 2016, Beximco Pharma became the first Bangladeshi pharmaceutical company to export medicine to the US market, following the approval of its oral solid dosage facility by the US FDA in June 2015. Cyproheptadine is now Beximco's seventh Abbreviated New Drug Application (ANDA) approved for the US market.
Mr. Nazmul Hassan MP, Managing Director of Beximco Pharmaceuticals, commented:"Cyproheptadine is our seventh product approved for the US market, and with our recent acquisition of eight ANDAs from Sandoz, our US portfolio now stands at 15 products. This approval gives us further confidence that our strategic focus and growing pipeline will strengthen our presence in the world's largest pharma market."
Beximco Pharma is a leading exporter of pharmaceuticals in Bangladesh. The Company currently has a global footprint in more than 50 countries and has been accredited by leading global regulatory authorities including the US FDA, AGES (EU), TGA (Australia), Health Canada, GCC (Gulf) and TFDA (Taiwan).
1. IQVIA market data
The information communicated in this announcement contains inside information for the purposes of Article 7 of Regulation 596/2014.
For further information please visit www.beximco-pharma.com or enquire to:
Beximco Pharma
Nazmul Hassan MP, Managing Director
Tel: +880 2 58611001, ext.20080
Md. Asad Ullah, FCS, Executive Director & Company Secretary
Tel; +880 2 58611891, +880 2 58612040, Ext 10140
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
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 4,200 employees are driving the company towards achieving its aspiration to be among the most admired companies in the world.