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Pune-based Brinton Pharmaceuticals said on Thursday it had got the nod from the Drugs Controller General of India (DCGI) to market its brand Faviton, priced at Rs 59 per tablet
The 'subject' of the letter was stated as: "Regarding the false claims and pricing of tab FabiFlu 200 mg (favipiravir) by Glenmark Pharmaceuticals Limited, India"
Higher yields and better scale allowed a price cut, said Company
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Company says it strongly disagreed with the charge, has 'overwhelming evidence' to support its innocence.
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Sources say Cipla-BDR's favipiravir will be at least 30 per cent cheaper than Glenmark's price of Rs 103 per tablet. Cipla did not confirm.
Glenmark Pharmaceuticals has launched the antiviral drug Favipiravir, while Cipla and Hetero have received approvals from the Drug Controller General of India to launch Remdesivir
As per the clinical trial protocol approved, 150 subjects with mild to moderate Covid-19 will be randomised in the study in a 1:1 ratio to Favipiravir with standard supportive care
Local pharma units have already started work on developing patented drugs, some have already approached regulator for approvals
US growth remains crucial for earnings upgrades, while licensing deals can help reduce both, costs and debt
The stock price of HUL and GSK Consumer rallied 5.08% and 5.72% each on Tuesday
The product is a generic version of AstraZeneca AB's Farxiga tablets
The company's US sales growth has remained subdued due to intense competition for its dermatology range.
Consolidated revenue of the company stood at Rs 2,735.56 crore for the quarter under consideration as against Rs 2,555.04 crore for the corresponding period a year ago.
Glenmark Pharmaceuticals on Tuesday said it has got final approval from the US health regulator for Deferasirox tablets for oral suspension. "Glenmark Pharmaceuticals Inc, USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (US FDA) for Deferasirox tablets for oral suspension, 125 mg, 250 mg and 500 mg, the generic version of exjade1 tablets for oral suspension, 125 mg, 250 mg and 500 mg, of Novartis Pharmaceuticals Corporation," the company said in a filing to the BSE. The tablet is used to treat high levels of iron in the body caused by multiple blood transfusions. According to IQVIA sales data for the 12-month period ending November 2019, exjade tablets for oral suspension -- 125 mg, 250 mg and 500 mg -- had annual sales of approximately USD 106.4 million (about Rs 750 crore). Glenmark's current portfolio consists of 165 products authorised for distribution in the US market and 43 ANDAs pending approval with the US FDA. In addition
This paves the way for the launch of Ryaltris in Australia through our partner, Seqirus
Glenmark Pharmaceuticals on Wednesday said it has received tentative nod from the US health regulator for dimethyl fumarate delayed-release capsules used for treating multiple sclerosis. The tentative nod granted by US Food & Drug Administration (USFDA) to Glenmark Pharmaceuticals Inc, USA (Glenmark) is for multiple strengths of dimethyl fumarate delayed-release capsules of 120 mg and 240 mg. These are generic version of Tecfidera Capsules, 120 mg and 240 mg, of Biogen Inc, Glenmark Pharmaceuticals said in a statement. Citing IQVIATM sales data for the 12 month period ending August 2019, the company said Tecfidera Capsules, 120 mg and 240 mg achieved annual sales of approximately USD 3.7 billion. Glenmark's said its current portfolio consists of 161 products authorised for distribution in the US market and 49 abbreviated new drug applications (ANDAs) pending approval with the USFDA.
Plant accounts for 7 per cent of company's US sales; firm says no major pending approvals from unit in the next 12 months
The United States Food and Drug Administration (USFDA) had inspected the facility between April 15 and April 20 and earlier classified the inspection as an official action indicated