Renata’s Rajendrapur facility wins US FDA approval
Pharmaceutical company, Renata Ltd has secured approval from the US Food and Drug Administration (FDA) for its general facility in Rajendrapur.
With this approval, the company expects to make inroads into the US market with plain generics, Para IV and NCE-1 filings.
"This approval proved the quality of drugs of Renata," Md Jubayer Alam, company secretary, told The Daily Star. Renata Ltd also made an announcement in a filing on the Dhaka Stock Exchange.
Investors, however, remained indifferent following the disclosure as shares of the drug-maker closed unchanged at Tk 1,303.20.
Presently, the UK and European Union comprise Renata's major export markets.
Renata said the approval came about after it had applied for marketing Metoprolol Tartrate tablet, which is prescribed for hypertension. As per the company, the approval translates to the 1,08,458 square feet facility capable of manufacturing and packaging tablets and capsules, being of international standard.
Renata has USFDA approval of seven products, said Alam. Of these, Rolip — a lipid-lowering drug used to treat high cholestrol and prevent cardiovascular diseases in those at high risk — is sold in Bangladesh.
Renata joins three local drug-makers — Eskayef Pharmaceuticals, Square Pharmaceuticals and Beximco Pharmaceuticals — have the US FDA's approval to export products.
Renata, which started its operations in 1972 as Pfizer (Bangladesh), booked a profit of Tk 511 crore in the financial year of 2021-22 whereas it was Tk 503 crore in the previous year. The pharmaceutical manufacturer's capitalisation stands at Tk 13,969 crore.