Page 2 - Generic Drugs

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

Fewer generics enter market after linagliptin's patent expiry this August

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

BDR Pharma launches generic drug for fungal infections at 1/3rd the cost

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

J&J, Lupin cut prices for tuberculosis drug in lower-income countries

(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.

Generic prescription controversy: NMC regulations for doctors held back

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

Top headlines: 7% Indians want doctors to prescribe generic drugs and more

Business Standard brings you the top headlines at this hour

Unhealthy prescription

Promoting generics is the wrong way to address a problem

What are generic medicines and how India became the 'pharmacy of the world'

India is the world's largest producer and exporter of generic drugs. But how did it manage to do so? Let us find out here

Doctors to be penalised for not prescribing generic drugs: NMC regulation

All doctors must prescribe generic drugs, failing which they will be penalised and even their license to practice may also be suspended for a period, according to the new regulations issued by the National Medical Commission. The National Medical Commission (NMC) in its 'Regulations relating to Professional Conduct of Registered Medical Practitioners" also asked doctors to avoid prescribing branded generic drugs. Even though doctors are currently required to prescribe generic drugs only, there are no penal provisions mentioned in the regulations issued in 2002 by the Indian Medical Council. The NMC regulations notified on August 2, stated that India's out-of-pocket spending on medications accounts for a major proportion of public spending on healthcare. "Generic medicines are 30 to 80 per cent cheaper than branded drugs. Hence, prescribing generic medicines may overtly bring down healthcare costs and improve access to quality care," it said. Under the generic medicine and prescrip

DRL enters trade generics, aims to be among top five players in market

Exploring strategic collaborations in the country, says pharma firm

Pharma companies seek price ceiling exemption for low-cost medicines

The industry and the government are on the same page on trade margin rationalisation, however, the industry wants it to be implemented in a phased manner

Zydus recalls over 55k bottles of generic drug used to treat gout in US

Drug firm Zydus Lifesciences is recalling over 55,000 bottles of generic medication in the US market due to failed impurities specifications. As per the latest enforcement report by the US Food and Drug Administration (USFDA), Zydus Pharmaceuticals (USA) Inc is recalling 21,936 (30 count) and 33,096 (100 count) bottles of Colchicine tablets, which are used to treat gout. The affected lot is manufactured by Ahmedabad-based Zydus Lifesciences and marketed in the US by New Jersey-based Zydus Pharmaceuticals (USA) Inc. USFDA said the company is recalling the product due to "failed impurities/ degradation specifications". An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine, it added. Zydus commenced the Class III recall on February 24 this year. As per the USFDA, a Class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health ...

Issued show cause notice to 31 firms for online sale of drugs: Govt in LS

The CDSCO has issued show cause notices to 31 firms based on representations raising concerns over the sale of drugs online or through other electronic platforms in contravention to the provisions of the Drugs and Cosmetics Act, 1940, the government informed the Lok Sabha on Friday. Cases concerning the quality of drugs, when reported, was is taken up with the State Licensing Authority (SLA) concerned for necessary action under the provisions of the Drugs and Cosmetics Act, Minister of State for Health Bharati Pravin Pawar said in a written reply. The SLAs are empowered to take action on violation of any conditions of such licenses, including prosecution in an appropriate court of law. She also told the Lower House of Parliament that as informed by Central Drugs Standard Control Organisation (CDSCO), various representations are received raising concerns regarding the sale of drugs through online or other electronic platforms in contravention to the provisions of the Drugs and ...