Page 2 - Generic Drugs

Trump's 'Make in America' push: Indian drug cos in no rush to make US shift

Pharma industry veteran said that the US wanting to encourage local production is a very natural thing to do

Gland Pharma gets USFDA nod for Vyzulta generic with 180-day exclusivity

Gland Pharma on Wednesday said it has received approval from the US health regulator for a generic medication to treat conditions related to high pressure in the eye. The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Latanoprostene Bunod Ophthalmic Solution, (0.024 per cent), the drug firm said in a statement. The company's product is bioequivalent and therapeutically equivalent to Bausch and Lomb, Inc's Vyzulta ophthalmic solution, it added. The product is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The company is the exclusive first-to-file and is eligible for 180 days of generic drug exclusivity, Gland Pharma said. According to IQVIA, the product had sales of around USD 171 million in the US for the 12 months ending February 2025. Shares of Gland Pharma on Wednesday ended 1.04 per cent down at Rs 1,398.35 apiece on the BSE.

Pharma shares slide up to 10% as Trump to announce pharma tariffs 'soon'

Trump tariffs: Blue Jet Healthcare, Aarti Pharmalabs, Marksans Pharma, Ipca, Wockhardt, Ami Organics, Biocon, Piramal Pharma, Lupin, Laurus Labs and Gland Pharma dropped in the range of 3% to 10%

Delhi High Court paves way for generics of spinal muscle atrophy drug

Innovator drug price is Rs 22-72 lakh per year; Analysts forecast Natco to price generic drug at Rs 3,000 per year

Indian generic drugs have 54% more adverse outcomes than US-made: Study

Generic drugs made in India are related to 54 per cent more severe adverse events, including hospitalisation, disability and death, compared to the equivalent generic drugs made in the US, a new study has found. The findings were largely driven by 'mature generic drugs' -- or those that had been in the market for a long time. "Where generic drugs are manufactured can make a significant difference," said co-author John Gray, a professor of operations at The Ohio State University's Fisher College of Business. A generic drug is a medicine created with the same chemical as an already marketed brand-name drug with same dosage, safety and effectiveness. The drug is allowed to be sold once patents for the original brand expire. The results, published in the journal Production and Operations Management, show that all generic drugs are not equal, even though patients are often told that they are, Gray said. "Drug manufacturing regulation and, therefore, quality assurance practices, differ

Zydus Lifesciences gets USFDA nod for generic schizophrenia treatment drug

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.

Domestic formulations biz expected to grow 9-10% over next decade: Glenmark

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

India's pharma sector set for 9.6% CAGR, reaching $55 bn by 2030: Report

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 Pharma introduces generic eye treatment medication in US

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 Pharmacy expands eligibility for subscription to Medicare patients

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

GSK seeks to appeal Delaware ruling allowing Zantac cases to go forward

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

Dozens of CVS drug recalls expose link to tainted factories in China, India

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

Lupin recalls 51k bottles of generic drug due to defective containers in US

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 launches generic drug for overactive bladder in US mkt

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 Clinical Research buys European CRO Heads for an undisclosed sum

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

Sun Pharma recalls 55,000 bottles of generic drug to treat gout from US mkt

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 recalls 8,000 bottles of generic drug in US over packaging error

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'

Lupin gets USFDA approval to market generic medication to treat diabetes

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.

Zydus Lifesciences gets final FDA nod for Darunavir for HIV-1 treatment

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

UK officials pressured to drop IP law demands in India trade talks

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