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Drug firm Glenmark said it has received approval from the US health regulator to market a generic medication to treat diabetes in the American market. Glenmark Pharmaceuticals Inc, USA, a unit of the company, has received tentative approval from the US Food & Drug Administration (US FDA) for Saxagliptin Tablets in strengths of 2.5 mg and 5 mg, the Mumbai-based drug maker said in a statement. The company's product is the generic version of AstraZeneca AB's Onglyza tablets (2.5 mg and 5 mg), it added. According to IQVIA sales data for the 12-month period ending December 2022, the Onglyza tablets (2.5 mg and 5 mg) achieved annual sales of around USD 122.3 million. Glenmark said its current portfolio consists of 179 products authorised for distribution in the US marketplace. The drug firm has 46 abbreviated new drug applications (ANDAs) pending approval with the USFDA, it added. In addition to these internal filings, Glenmark continues to identify and explore external development ...
Pharmaceuticals firm Lupin Ltd on Thursday said its US-based arm is recalling four lots of Quinapril tablets used to treat high blood pressure due to the presence of a nitrosamine impurity. Lupin Pharmaceuticals Inc, the company's wholly-owned arm, is recalling the said tablets due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the acceptable daily intake (ADI) level, Lupin Ltd said in a regulatory filing. "To date, Lupin has received no reports of illness that appear to relate to this issue," it said, adding it discontinued marketing of Quinapril tablets in September 2022. Quinapril tablets of strengths 20mg and 40mg packaged in separate 90 count bottles were distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets, it added. The filing further said Lupin Pharmaceuticals Inc is notifying its wholesalers, distributors, drug chains, mail order pharmacies and supermarkets by phone and throug
High-value drugs like cocaine, methamphetamine and heroin have witnessed record seizures by revenue intelligence officers in the last fiscal, according to a report by the Directorate Revenue Intelligence. Signalling a disturbing trend, the figures revealed that the seizure of highly addictive party drug cocaine has shot up 36-fold to 310 kg in 2021-22 from 8.7 kg in 2020-21 and just 1.1 kg in 2019-20. Another high-value party drug methamphetamine saw a 14-fold increase in seizures by DRI officers at 884.69 kg in 2021-22, up from 64.39 kg in 2020-21. Besides, 3,410.71 kg of heroin, a highly addictive opioid drug, was seized in 2021-22, up 17-fold from the previous fiscal. Of this, 2,988 kg was seized at Mundra port in 2021-22. In 2020-21 and 2019-20, 202 kg and 143 kg of heroin were seized by the DRI officers across the country. According to the DRI report, two key trends have been observed in drug smuggling in recent times. These are the trafficking of heroin via trade routes, ...
A panel of federal health advisers have voted to recommend approval for an experimental drug to treat Lou Gehrig's disease, a remarkable turnaround for the much-debated medication that was previously rejected by the same group earlier this year. The Food and Drug Administration advisers voted 7-2 that data from Amylyx Pharma warranted approval, despite hours of debate about the strength and reliability of the company's lone study. The FDA is not required to follow the group's advice, but its positive recommendation suggests an approval is likely later this month. The FDA has approved only two therapies for the disease, amyotrophic lateral sclerosis, or ALS, which destroys nerve cells needed for basic functions like walking, talking and swallowing. ALS patients and their families have rallied behind Amylyx's drug, launching an aggressive lobbying campaign and enlisting members of Congress to push the FDA to grant approval. Despite a negative review published by FDA's internal ...
Glenmark Pharmaceuticals on Thursday said it has launched a novel fixed-dose combination (FDC) drug in the country for patients with uncontrolled asthma. The Mumbai-based drug major has launched - Indacaterol + Mometasone FDC under the brand name Indamet. The drug will be available in three strengths with a fixed dose of Indacaterol 150 mcg and variable doses of Mometasone 80 mcg, 160 mcg and 320 mcg to be taken once daily. "Respiratory is a key focus area for Glenmark, and the company leads from the front in providing access to the latest treatment options to patients. "We are proud to introduce this novel fixed-dose combination Indamet, which is the first of its kind in India, offering an affordable treatment option to both adults and adolescents 12 years of age and older suffering from uncontrolled asthma," Glenmark Pharmaceuticals Group Vice President & Head (India Formulations) Alok Malik said in a statement. The drug maker is the first company in India to market the FDC of .