Generic Drugs

Zydus Lifesciences Ltd on Thursday said it has received final approval from the US health regulator to manufacture its generic version of Paliperidone extended-release tablets, used to treat schizophrenia. The approval by the US Food and Drug Administration (USFDA) is for Paliperidone extended-release tablets of strengths 1.5 mg, 3 mg, 6 mg, and 9 mg, Zydus Lifesciences said in a regulatory filing. These tablets will be produced at the group's manufacturing site at SEZ, Ahmedabad, it added. Paliperidone extended-release tablets are indicated for the acute and maintenance treatment of schizophrenia, acute treatment of schizoaffective disorder as monotherapy and acute treatment of schizoaffective disorder as an adjunct to mood stabilisers and/or antidepressants, the company said.

The drug formulations market in India is expected to grow at a CAGR of 9-10 per cent over the next decade with Jan Aushadhi outlets anticipated to emerge as a much stronger player in the country, according to Glenmark Pharmaceuticals. The domestic formulations market is estimated to be at Rs 2 lakh crore, with a growth rate of 11 per cent over the past two decades. "It is projected that the domestic formulations market will maintain a compound annual growth rate (CAGR) of 9-10 per cent over the next decade," the Mumbai-based drug maker said in its Annual Report for 2023-24. As the Trade Generics and Jan Aushadhi channels expand, it is anticipated that these channels could collectively contribute 30 per cent to the market volume in ten years, it stated. The Jan Aushadhi initiative aims to enhance access to cost-effective, unbranded generics by scaling up to 25,000 franchise pharmacies by 2026, it said. "It is estimated that Jan Aushadhi procurement could account for 3-5 per cent o

Key segments contributing to the growth of India's pharma sector will be patented drugs, branded generics, and trade generics, according to a report by Pharmarack Technologies

Glenmark Pharmaceuticals on Monday said its US-based subsidiary has introduced a generic medication used for eye itching. Glenmark Therapeutics Inc, USA has launched Olopatadine Hydrochloride Ophthalmic Solution (OTC) in the US market, the Mumbai-based drug maker said in a regulatory filing. Fabio Moreno, Head of OTC Sales & Marketing, Glenmark Pharmaceuticals Inc, said the launch of Olopatadine Ophthalmic Solution (USP, 0.1 per cent), addresses a growing demand for a new supplier in this category. "This addition highlights our commitment to meeting market needs and providing high-quality over-the-counter solutions for our customers," Moreno said.

Amazon has worked to lure customers away from more established pharmacies like CVS and Walgreens since launching its pharmacy unit in 2020

The companies, which all sold Zantac at different times, argue that Medinilla should have granted their motion to block plaintiffs from presenting expert testimony that Zantac causes cancer

The drugs were among those sold by CVS Health Corp., the largest US pharmacy, under its store-brand label before being recalled

Drug firm Lupin is recalling over 51,000 bottles of a generic antibiotic medication in the US market due to a "defective container", according to the American health regulator. The US-based arm of the drug maker is recalling 51,006 bottles of Cefdinir for Oral Suspension (250 mg/5 mL) due to "defective container: lack of seal integrity," US Food and Drug Administration (USFDA) said in its latest Enforcement Report. Cefrine Oral Suspension is indicated for the treatment of a range of bacterial infections. The affected lot has been manufactured at Lupin's Mandideep-based plant and marketed in the US by Baltimore-based Lupin Pharmaceuticals, Inc, it said. The drug maker initiated the Class II nationwide (US) voluntary recall on May 8 this year. As per the USFDA, a Class II recall is initiated in a situation in which the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health

Zydus Lifesciences on Monday said it has launched a generic medication to treat overactive bladder in the US market. The company has launched Mirabegron extended-release tablets in strength of 25 mg in the US market after having received final approval from the US Food and Drug Administration (USFDA), Zydus Lifesciences said in a regulatory filing. Zydus is among the first suppliers to launch the generic version of Mirabegron extended-release tablets (USP 25 mg) in the US market. The company is also preparing to launch the 50 mg tablets in the market, it added. Mirabegron is indicated for the treatment of Overactive Bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. The drug will be manufactured at the Zydus group's formulation manufacturing facility in Ahmedabad SEZ, India, the drug maker said. Zydus CEO Americas, Punit Patel said the launch of generic Mirabegron will improve access and availability of the generic product for patients in the

Veeda expands its footprint across major regions and will gain expertise in late-stage oncology trials

Drug major Sun Pharma is recalling around 55,000 bottles of a generic medication to treat gout from the American market due to manufacturing practices norms deviations, according to the US health regulator. The New Jersey-based unit of the Mumbai-based drug major is recalling Febuxostat Tablets in 40 mg and 80 mg strengths, US Food and Drug Administration (USFDA) said in its latest Enforcement Report. Sun Pharmaceutical Industries Inc is recalling 47,520 bottles (40mg) and 7,488 bottles (80 mg) respectively of the medication due to Current Good Manufacturing Practice regulations (CGMP) deviations, it stated. "Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment," the USFDA stated. The affected lot was produced at Sun Pharma's Dadra-based plant for Memphis-based Northstar Rx LLC, the US regulator noted. Febuxostat is used to lower uric acid levels in people with gout. As per the USFDA, the company has initiated the Class II nationwide (

Dr Reddy's Laboratories is recalling over 8,000 bottles of a generic medication used to prevent rejection of a transplanted organ from the US market due to a packaging error, according to the US Food & Drug Administration. The Hyderabad-based drug major is recalling 8,280 bottles of Tacrolimus capsules from the US market for "presence of foreign tablets/capsules" in the affected lot. One 0.5 mg Tacrolimus capsule was found in a bottle of 1 mg Tacrolimus capsules, the USFDA stated in its latest Enforcement Report. The affected lot was produced at Dr Reddy's Bachupally-based plant near Hyderabad. New Jersey-based Dr Reddy's Laboratories, Inc has initiated the nationwide (US) Class II recall on December 15, 2023. As per the USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Dr Reddy'

Drug firm Lupin on Thursday said it has received approval from the US health regulator to market a generic medication to treat diabetes. The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Dapagliflozin and Saxagliptin tablets, the Mumbai-based drug maker said in a regulatory filing. The company's product is a generic equivalent of AstraZeneca AB's Qtern tablets, it added. This generic product will be manufactured at its Pithampur facility, the company said. Dapagliflozin and Saxagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. As per IQVIA data, Dapagliflozin and Saxagliptin tablets had estimated annual sales of USD 5 million in the US market.

According to market research firm IQVIA, Darunavir Tablets, 75 mg, 150 mg, 600 mg, and 800 mg had annual sales of $275 million in the US

Critics say the changes would damage India's position as a leading provider of generic drugs - essentially "copycat" versions of those which fall out of patent

When Sitagliptin went off patent, nearly 200 brands were vying for a share of the market

Zisavel capsules will be available as 100 mg capsules and will be priced at Rs 7,992 for 7 capsules

(Reuters) - Johnson & Johnson and Indian drugmaker Lupin will supply their versions of the tuberculosis drug bedaquiline at a significantly cheaper price in low- and middle-income countries, a global anti-tuberculosis group said on Wednesday.

India is a branded generic drugs market where pharma companies sell copy-cat drugs (those that are off patent) under different brands

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