Beximco Pharma receives US FDA approval for Cyproheptadine

Wed, Apr 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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