Beximco Pharma receives US FDA approval for Cyproheptadine


-- April 24, 2019

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.


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Proyash


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  • A specialized institute that works for the holistic development of children with special educational needs through different programs
  • Include early childhood development programs (ECD), special schooling, therapeutic interventions, medical and neuro-developmental assessment, leisure time and co-curricular activities, training for the teachers, parents and integrated services


Other CSR Initiatives


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  • Charity contributions through the Gono Sahajjo Songstha (GSS) for the educational sector for the unprivileged
  • Free drugs during natural calamities and distribution of clothing during winter
  • As part of BEXIMCO Group’s focus on society development, Fazlur Rahman Foundation has established a project called "FRF Diagnostic Centre". The project provides health screening services for Beximco Pharmaceuticals and Beximco Antibiotics Industries employees.
  • Sponsoring events and national sport stars and teams
  • Official sponsor of the Bangladesh National Cricket team for the ICC Cricket World Cup 2011
  • Official sponsor of the FIFA friendly match between Argentina and Nigeria held in September, 2011