Drug firm Strides Pharma Science on Tuesday said its step down subsidiary has received approval from the US health regulator for Ethacrynic Acid tablets, used to treat fluid retention (edema)
The company had reported a strong improvement in profitability in Q1 despite Ranitidine suspension in Q4.
The company reported strong performance across all businesses in Q1FY21 despite significant disruptions and ambiguity in the business environment due to Covid 19.
Drug firm Strides Pharma Science on Thursday said it has received approval from the US health regulator for generic Prednisone tablets used as an anti-inflammatory medication. Strides Pharma Global Pte Ltd, Singapore, company's step-down wholly owned subsidiary, has received approval for Prednisone tablets USP in the strength of 1 mg from the United States Food & Drug Administration (USFDA), Strides Pharma Science said in a filing to the BSE. The product is a generic version of Schering Corporation's Meticorten tablets in the same strength, it added. The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market,the filing said. According to IQVIA MAT July 2020 data, the US market for Prednisone tablets USP 1 mg is approximately USD 12 million (about Rs 88 crore), it added. Prednisone belongs to a class of drugs known as corticosteroids and is used as an anti-inflammatory or an immunosuppressant medication. It i
Ursodiol is used for treatment of patients with primary biliary cirrhosis (PBC)
In a Q&A, pharma major's MD & CEO, R Ananthanarayanan says the firm is setting up a vaccine suite and is in final-stage talks with global players to seal a deal for developing a Covid-19 vaccine
Glenmark was the first Indian firm to get approval from regulator to conduct trials on Favipiravir tablets, which are otherwise used to treat influenza
Favipiravir is manufactured under the brand name Avigan by a unit of Japan's Fujifilm Holdings Corp and was approved for use as an anti-flu drug in the country in 2014
Firm says will apply to Indian pharma authorities to start studies
The Bengaluru-headquartered company posted a 358 per cent rise in net profit at 101 crore as compared to the corresponding quarter of the previous financial year
The Bengaluru-headquartered company believes Stelis could be a disruptor in insulin accessibility and affordability.
Ranitidine sales account for 2 per cent of Strides sales and 6 per cent of its profit after tax
It had posted a loss of Rs 8.70 crore for the corresponding period of FY19.
Strides predominantly sells Ranitidine tablets in the US markets
Strides Pharma Science said the site has undergone several successful USFDA inspections and has no outstanding observations
Strides Pharma Global Pte (Singapore) and Sun Moral International (Hong Kong), a wholly-owned subsidiary of Sihuan Pharmaceutical Holdings, have entered into a JV to form called Sihuan Strides.
The development comes in the backdrop of the recent regulatory developments in China which has enabled fast track approvals of differentiated high-quality generics approved in key regulated markets
The flagship facility in Bengaluru is the largest manufacturing facility for the company with capabilities to produce finished dosage products across multiple formats
USFDA has classified the facility as OAI based on the inspection conducted from January 28 to February 5, 2019
The stock moved higher by 6.4% to Rs 458 on BSE after the company announced that its JV has received USFDA nod for tapeworm infection treatment drug.