LUPIN LIMITED

Lupin Biotech's facility manufactures mammalian and microbial products for global markets, adhering to ICH biosimilar guidelines. The USFDA issued six observations during a recent inspection, prompting a corrective action plan. Lupin recently launched a generic cancer treatment drug in the US market.

Zydus Life share price rose 1% after USFDA approval for prostate cancer drug, Enzalutamide Capsules, 40 mg. The stock has surged 76% in a year, pushing market cap to over Rs 1.1 lakh crore, outperforming NSE Nifty 50. However, shares have fallen 17% since August due to profit booking and competitive pressure.

Lupin's Pithampur Unit-1 received Form 483 from USFDA with 3 observations after inspection. Alembic Pharmaceuticals received an EIR from USFDA for its oral solid formulation facility inspection.

Lupin received FDA approval for bumetanide injection, 1 mg/4 ml and 2.5 mg/10 ml vials, a generic of Validus Pharmaceuticals’ Bumex, to be manufactured at its Nagpur facility. The injection treats edema related to heart failure, liver and kidney diseases, and nephrotic syndrome, with a market value of about $20 million.

The U.S. general anesthesia drugs market is projected to grow from USD 1.98 Billion in 2024 to USD 2.56 Billion by 2033, driven by increasing surgical procedures, technological advancements, and regulatory updates. Key segments include propofol, intravenous drugs, knee and hip replacements, and hospitals, with ambulatory surgical centers expected to grow fastest. Major players include GE Healthcare, Pfizer, and Hospira Inc.

India contributes 8-10% of global API supply, with 1,500 pharma companies manufacturing and exporting APIs. Key players include Neuland Laboratories, Marksans Pharma, Dr Reddy's Laboratories, Cipla, and Lupin, each focusing on diverse therapeutic areas and expanding capabilities. Investors should evaluate financial health and adaptability due to regulatory challenges and market fluctuations.

Lupin and Takeda Pharmaceutical have signed a non-exclusive patent licence agreement for the commercialisation of Vonoprazan tablets in India, branded as Lupivon. The drug, a potassium-competitive acid blocker, will be available in 10mg and 20mg strengths and is approved for treating gastric ulcers, reflux esophagitis, duodenal ulcers, and as part of the Helicobacter pylori eradication regimen. This move aims to expand Lupin's gastroenterology portfolio in India, where acid peptic disorders are highly prevalent.

Indian pharma giants focus on quality over quantity, with complex product filings increasing. US generics sales show slight growth, and regulatory challenges ease. Nomura recommends Lupin for its upcoming launches and stable market shares, while noting setbacks. Sun Pharma's specialty segment growth slows, and Dr Reddy's faces market share declines. Cipla and Zydus Lifesciences show growth but face inspection and competition challenges.

The 'Migraine: Seven-Market Drug Forecast and Market Analysis' report, added to ResearchAndMarkets.com's offering, forecasts the migraine market in the US, France, Germany, Italy, Spain, the UK, and Japan to grow from $9.2 billion in 2023 to $16.4 billion by 2033, driven by a 6.0% CAGR. The report covers epidemiology, treatment options, unmet needs, pipeline analysis, and market competition.