Pharma major Lupin Ltd on Friday said it has received approval from the US health regulator to market its generic 'Minzoya' tablets used to prevent pregnancy. The approval granted by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Minzoya (Levonorgestrel and Ethinyl Estradiol tablets, and Ferrous Bisglycinate tablets) of strengths 0.1 mg/0.02 mg and 36.5 mg, Lupin said in a regulatory filing. The drug is a generic equivalent of Balcoltra (Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets) 0.1 mg/0.02 mg and 36.5 mg, of Avion Pharmaceuticals LLC, it added. The product will be manufactured at Lupin's Pithampur facility in India, the company said. Minzoya tablets are indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel and Ethinyl Estradiol tablets, and Ferrous Bisglycinate tablets had estimated annual sales of USD 42 million in the US, the company said citing IQVIA MAT
India's stand on intellectual property rights (IPRs) and pharma issues in proposed trade agreements balances innovation with public health needs, ensures availability of affordable medicines and promotes growth of generic medicine industry, a GTRI report said on Friday. Think tank Global Trade Research Initiative (GTRI) said that by opposing demands of developed nations on issues like 'data exclusivity' and 'patent linkage' in free trade agreements (FTAs), India ensures that generic drug manufacturers get greater market access and cost of life-saving medicines gets reduced significantly. "India's approach underscores a commitment to balancing innovation with public health needs, adopting a flexible interpretation of TRIPS to align with its developmental goals, and preventing the establishment of unfair monopolies, especially in the pharmaceutical sector," the GTRI paper said. It added that this stance reflects a broader effort to protect traditional knowledge and ensure the ...
Pfizer introduced Lipitor in 1997, and the drug drove more than $130 billion in sales during its first 14 years on the market
The bank has said it has taken note of the proposal and the Board of Directors of the lender will meet in due course and evaluate the proposal and other options to achieve regulatory compliance
Akums Drugs and Pharmaceuticals Ltd has filed draft papers with capital markets regulator Sebi to raise funds through an initial public offering (IPO). The initial share-sale is a combination of fresh issue of equity shares worth Rs 680 crore and an offer-for-sale (OFS) of 1.86 crore shares by promoters and an existing investor, according to the draft red herring prospectus (DRHP) filed on Saturday. Those selling shares in the OFS are Sanjeev Jain, Sandeep Jain and Ruby QC Investment Holdings Pte Ltd. The company is looking to raise Rs 136 crore through a pre-IPO placement. If such placement is undertaken, then fresh issue size will be reduced. Proceeds from the fresh issue will be used to repay debt, fund working capital requirements of the company, pursue inorganic growth initiatives through acquisition and for general corporate purposes. Founded in 2004, Akums is a pharmaceutical contract development and manufacturing organization (CDMO) offering a comprehensive range of ...
MedPlus Health Services, a retail pharmacy and diagnostics chain in India, is set to elevate its "store generics" (in-house brand) to 50-60 per cent contribution to the firm's revenues in the next two to three years, drawing inspiration from the successful practices of US pharma retail giants like Walgreens and CVS. The concept of "store generics" involves a retail chain exclusively selling its own branded medications alongside innovator drugs. MedPlus currently witnesses around 12 per cent of its revenues from store generics. This strategic move follows the triumphant adoption of the "store generics" model in Telangana and subsequent expansions into Andhra Pradesh, Tamil Nadu, Karnataka, Maharashtra, West Bengal, and Odisha, Gangadi Madhukar Reddy, MD CEO of MedPlus said. Over the past six months, MedPlus has witnessed over 26.2 lakh customers saving a substantial Rs. 139.7 crores by opting for MedPlus brands, he said. To ensure the quality and efficacy of their medications, MedPl
Indian generic drugmaker Zydus Lifesciences reported a bigger-than-expected rise in third-quarter profit on Friday, driven by strong sales in its domestic and overseas markets
The partnership will provide Sandoz the exclusive rights to promote, sell, and distribute biosimilar Trastuzumab and biosimilar Bevacizumab in Australia
The domestic formulation business has been the growth driver during the quarter, clocking a 14 per cent Y-o-Y growth to Rs 462 crore
JB Chemicals & Pharmaceuticals on Tuesday said its net profit rose 26 per cent to Rs 134 crore for the third quarter ended December 2023. The company reported a net profit of Rs 106 crore in the October-December period of the last fiscal. Revenue increased to Rs 845 crore in the third quarter compared to Rs 793 crore in the year-ago period, JB Pharma said in a statement. "Our focus on growing the domestic business ahead of the market continues, as reflected in the Q3 performance. The business once again stands out in this quarter," JB Pharma CEO and Wholetime Director Nikhil Chopra stated. In the international division, the formulations business is stable, he added. "Our approach to develop progressive portfolios is on track, resulting in a positive impact for the exports branded generics business," Chopra said. Shares of the company settled 1.18 per cent higher at Rs 1,724 apiece on the BSE.
The drug, nipocalimab, significantly reduced symptoms of generalized myasthenia gravis (gMG) in a late-stage study, and in a mid-stage study helped reduce Sjogren's disease severity, J&J said
America's reliance on China for drug ingredients has raised alarm bells in Congress. House committees will hold two hearings Tuesday on drug shortages
Alembic Pharmaceuticals' revenue from operations rose 8% in the December-quarter, led by a 9% rise in its India and U.S. businesses each
Rx for returns: Pharma firms' dominance in market recovery prescription
Drug major Cipla is eyeing acquisitions and inorganic partnerships in the US market while consolidating its presence across segments in the domestic market. The Mumbai-based company is also looking to improve the top line in Europe and margin expansion in South Africa. "Product launches through delisting strategy and as well as inorganic partnerships and acquisitions will remain one of our key priorities for the US market," Cipla Global Chief Financial Officer Ashish Adukia said in an analyst call. The drug maker would also focus on commercial execution of existing portfolios and resolution of USFDA observations, he added. In the South African market, Cipla would build on its performance aided by growth in private and select tender business with greater emphasis on margin expansion, Adukia stated. "In emerging markets and Europe, top priority is to improve top line while margins are maintained at sustainable levels," he said. As per the yearly trend, the fourth quarter will have
The company, which makes popular antacid medicine Digene, said its profit rose to 3.11 billion rupees ($37.5 million) from 2.47 billion rupees a year earlier
Mankind's revenue from operations rose to Rs 2,607 crore in Q3 FY24, a 25 per cent Y-o-Y rise in revenue from operations from Rs 2,128 crore in Q2 FY23
Online pharmacy dropped plan for an IPO in 2022, says it is cutting down expenses
The New York-based drugmaker earned 10 cents per share on an adjusted basis for the fourth quarter. Analysts on average had expected a loss of 22 cents per share, according to LSEG data
The Hyderabad-based drug major had reported a net profit of Rs 1,247 crore for the October-December quarter of the last fiscal