GENERIC DRUGS
Zydus Lifesciences gets USFDA nod for generic topical anaesthetic cream
Zydus Lifesciences got USFDA approval for a generic anesthetic cream. The cream combines Lidocaine and Prilocaine. It numbs skin for minor procedures. Production will happen at their Ahmedabad site. This cream already generates millions in US sales.
Lupin shares in focus after FDA approval for generic HIV tablets
Lupin Share Price: Indian pharmaceutical giant Lupin gained US FDA approval for its generic version of Gilead Sciences' HIV drug Descovy. This win grants Lupin 180 days of shared exclusivity in the US market, a significant boost for the company. The generic drug will be produced at Lupin's Nagpur facility. Lupin's shares saw a 2.
Granules India gets USFDA nod for generic drug
Granules Pharmaceuticals, Inc. secured USFDA approval for generic Lisdexamfetamine Dimesylate chewable tablets. The tablets treat ADHD in children and adults. They also treat binge eating disorder in adults. The drug is available in various strengths. This approval addresses drug shortages. Granules India's chairman emphasized their commitment to patient needs.
Aurobindo Pharma, Glenmark recall products in US
Aurobindo, Glenmark, and Zydus are recalling pharmaceutical products in the US due to manufacturing issues. Aurobindo and Glenmark's recalls involve excessive impurities, while Zydus's recall is due to a labeling error. The recalls affect over 200,000 bottles/packs of various medications, including Cinacalcet, Diltiazem, and Esomeprazole.
Amid pollution woes, Asthma drug demand drives pharma retail market growth in November
India's pharmaceutical retail market rebounded in November with double-digit growth, fueled by increased demand for dermatological, cardiac, and respiratory medications. Foracort led sales, followed by Augmentin and Glycomet GP. Sun Pharma maintained market leadership. Analysts predict continued growth, boosted by new product launches, including anticipated generic GLP-1 drugs in 2025.
Aurobindo unit gets USFDA nod for generic cancer drug
Aurobindo Pharma's subsidiary, Eugia Pharma, gets USFDA nod for cancer drug Pazopanib. The drug treats renal cell carcinoma and soft tissue sarcoma. Launch expected in Q4FY25. The market size is estimated at USD 106 million. Aurobindo's shares closed slightly lower on Thursday. The drug is a generic version of Novartis's Votrient.
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Novo Nordisk India execs urge early Wegovy launch as weight-loss rival looms
Novo Nordisk's team in India is urging the company to launch its popular weight-loss drug, Wegovy, next year to stay ahead of rival Eli Lilly. Concerns have been raised about Novo potentially lagging behind if Wegovy is not introduced before Lilly's drug, Mounjaro, in the Indian market where demand is high.
Zydus eyes M&A, licensing to build its US specialty business
Zydus Lifesciences is exploring mergers, acquisitions, and licensing to bolster its specialty portfolio in the US, particularly for the potential launch of its liver therapy drug. The company also aims to expand into medical devices, diagnostics, and nutrition businesses, focusing on profitable growth and a discovery-led approach by 2030.
Glenmark launches generic glaucoma treatment ophthalmic solution
Glenmark Pharmaceuticals Inc., USA launched a generic version of Travatan Z, a glaucoma treatment, called Travoprost ophthalmic solution (0.004%). This bioequivalent solution expands Glenmark's ophthalmic product line and addresses market demands. Travatan Z generated approximately $66.2 million in sales over the past year.
Dr Reddy's, FDC recall products in US for manufacturing issues
Dr Reddy's Laboratories and FDC Ltd issued voluntary recalls for medications in the US market due to manufacturing defects. Dr Reddy's recalled lots of Morphine Sulfate extended-release tablets due to failed impurity specifications, while FDC Ltd recalled Timolol Maleate ophthalmic solution due to defective containers hindering solution dispensing.
Alembic Pharmaceuticals gets USFDA nod for generic hypertension treatment capsules
Alembic Pharmaceuticals Ltd has secured final approval from the USFDA for its generic Diltiazem Hydrochloride extended-release capsules. These capsules, available in strengths of 120 mg to 360 mg, are designed to treat hypertension and manage angina. This approval grants Alembic access to an estimated market valued at USD 105.3 million annually.
Lupin Q2 Results: Net profit soars 74% YoY to Rs 853 crore on strong demand for generic drugs
Lupin exceeded profit expectations in the second quarter, reporting a 74% surge in profits, reaching ?8.53 billion. This growth was fueled by robust demand for their respiratory and diabetes medications. Overall revenue also saw an 11.3% increase, reaching ?54.97 billion.
Health groups raise concerns over patents for rare disease drugs
Health groups and patient advocates are raising concerns over patent monopolies on rare disease drugs in India. They argue that these monopolies, like the one held by Roche for the spinal muscular atrophy drug Risdiplam, restrict access to affordable medication.
Dr Reddy's recalls over 3.3 lakh bottles of generic medication in US: USFDA
Dr Reddy's Laboratories is recalling over 3.3 lakh bottles of Cinacalcet tablets in the US due to manufacturing issues. The recall is due to the presence of an impurity above FDA limits. The recall affects 30 mg, 60 mg, and 90 mg strengths, with the affected lot produced in India. The recall was initiated on October 9, 2023.
One nation, one check: India needs centralised drug regulation to ensure public health
Centralisation of drug regulation in India is critical to ensure consistent drug quality and safety standards nationwide. The current fragmented system leads to regulatory inconsistencies, allowing substandard drugs into the market, threatening public health and India's pharmaceutical reputation. Strengthening central oversight is essential for effective enforcement.
Diabetes, cardiac drugs market grows over 3x in 10 years
India's cardiac and anti-diabetes drugs market has surged over threefold in the past decade, reaching ?30,000 crore and ?17,000 crore respectively. Innovative medicines and loss of patents have driven growth, with several brands now contributing significantly to market turnover.
Alembic Pharma gets USFDA nod for generic hypertension treatment capsules
Alembic Pharmaceuticals has received USFDA final approval for its generic Diltiazem Hydrochloride extended-release capsules in strengths of 120 mg, 180 mg, and 240 mg to treat hypertension and chronic stable angina. These capsules are therapeutically equivalent to Allergan Sales LLC¡¯s Dilacor XR, with an estimated market size of USD 28.2 million.
Piyush Goyal holds meeting to address concerns of pharmaceutical exporters
Union Commerce Minister Piyush Goyal engaged with key pharmaceutical industry stakeholders, including the IMDA's General Secretary, to tackle challenges faced by pharmaceutical exporters and enhance India's position in the global market. The meeting highlighted collaborative efforts to address hurdles and maintain competitiveness in quality and pricing.
US co Amneal plans units in India for weight-loss drugs
Amneal Pharmaceuticals is set to invest $150-200 million over four to five years to build a manufacturing facility in Ahmedabad for weight loss drugs. Partnering with US biotech firm Metsera and receiving Gujarat government incentives, the total project size may reach $250-300 million.
Quick access to key HIV drug hinges on waiver of local clinical trials: Experts
Faster access to HIV drug lenacapavir in India hinges on the waiver of local clinical trials. Six companies, including three from India, have non-exclusive, royalty-free licenses to produce generic versions. They must apply for waivers to supply the drug locally and in 120 low- and middle-income countries. Approval from the drug regulator is crucial.
Emcure Pharmaceuticals partners with Gilead Sciences to produce HIV prevention drug Lenacapavir
Emcure Pharmaceuticals has partnered with Gilead Sciences Ireland UC to manufacture and distribute generic lenacapavir for HIV prevention and treatment. This royalty-free agreement focuses on increasing access to the drug in 120 countries, especially resource-limited nations. Emcure aims to provide high-quality, low-cost HIV medication to improve health outcomes globally.
Alembic Pharma gets USFDA nod for generic drug used to treat schizophrenia
Alembic Pharmaceuticals has received final approval from the USFDA for its generic version of Paliperidone extended-release tablets, used to treat schizophrenia and schizoaffective disorder. The approval covers strengths of 1.5 mg, 3 mg, 6 mg, and 9 mg. The market size for these tablets is estimated at USD 48 million for the year ending June 2024.
Demand for generic medicines in India growing rapidly, notes recent UBS report
???As these stores expand, the sales of more expensive branded medicines are likely to be impacted. As of 30th June, 2024, about 12,616 Janaushadhi Kendras are active across the country.
Alembic Pharma gets USFDA nod for generic product
Alembic Pharmaceuticals has received approval from the USFDA to market Albendazole Tablets USP (200 mg), a generic drug for treating infections caused by worms. The tablets are equivalent to Impax Laboratories' Albenza and are used for conditions like parenchymal neurocysticercosis and cystic hydatid disease. Alembic Pharma shares rose 2.79% on Thursday.
Lupin launches generic cancer drug in US
Lupin has launched a generic cancer treatment drug, Doxorubicin Hydrochloride Liposome Injection, in the US market. The product is a generic version of Baxter Healthcare Corporation's Doxil and is used to treat ovarian cancer, AIDS-related Kaposi's Sarcoma, and multiple myeloma. The drug had an estimated annual sales of USD 40.9 million.
Alembic Pharma gets USFDA nod for generic drug
Alembic Pharmaceuticals has been granted final approval from the USFDA for its generic Betamethasone Valerate Foam, intended to treat moderate-to-severe psoriasis of the scalp. This medication is equivalent to Luxiq Foam by Norvium Bioscience. Alembic¡¯s shares ended 0.97% lower at Rs 1,089.90 on the BSE.
Indoco Remedies gets USFDA nod to market Lofexidine tablets with 180 days exclusivity
Indoco Remedies Ltd was granted approval from the USFDA to sell its generic Lofexidine tablets, used for opioid withdrawal. This approval includes 180 days of market exclusivity. The company plans an immediate US launch, manufacturing the product in Goa. Expected sales are estimated at USD 15.59 million, with significant growth anticipated.
Alembic gets USFDA nod for generic medication
Alembic Pharmaceuticals announced approval from the USFDA to market Dabigatran Etexilate Capsules (110 mg) for deep vein thrombosis prophylaxis, equivalent to Pradaxa Capsules. The company now has 211 ANDA approvals. Shares closed 3.17% lower at Rs 1,076 on the BSE.
Indian pharma companies faked generic viagra data to gain approval, finds US FDA
FDA's June 18 alert revealed falsified data by Synapse Labs affecting generics like Umedica's Viagra. Europe had earlier warned. Insurers might change coverage. Both Massoud Motamed and Erin Fox highlight ingredient risks. Due to confidentiality, FDA hasn't disclosed all affected drugs, suspended sales, or done significant public outreach. Identified generics include Lupin's Lipitor and Aurobindo's risendronate.
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