Beximco Pharmaceuticals Limited (BPL), the fast-growing manufacturer of generic pharmaceutical products and active pharmaceutical ingredients, announces it has received US Food and Drug Administration (FDA) approval for its anti-allergy drug.
The anti-allergy drug Cyproheptadine Hydrochloride Tablet (4 mg), is a generic equivalent to Periactin®Tablets (4 mg) from Merck and Company, Inc., according toa press release.
Cyproheptadine is an antihistamine used to relieve allergy symptoms such as hives, watery eyes, sneezing and itchy eyes or nose.
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.
“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 pipelinewillstrengthen our presence in the world’s largest pharma market,” the press release quoted Beximco Pharma Managing Director Nazmul Hassan MP as saying on new US approval.
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 includingthe US FDA, AGES (EU), TGA (Australia), Health Canada, GCC (Gulf) and TFDA (Taiwan).