Pharmaceuticals
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.
Indian pharma exporters feel pain on Bangladesh crisis
The political unrest and violence in Bangladesh are posing significant challenges for Indian pharmaceutical exporters, leading to stranded funds and concerns over financial stability. This situation threatens to impact medicine availability and healthcare services in Bangladesh. Despite the market's growth potential, many Indian companies are now hesitant to supply without advance payments, emphasising the importance of risk management in this unpredictable scenario.
Zydus Lifesciences gets USFDA nod for generic medication
Zydus Lifesciences has received approval from the USFDA to market Amantadine extended-release capsules (68.5 mg) and tentative approval for Gocovri (137 mg) capsules for treating Parkinson's disease. The drug will be produced at the company's Ahmedabad facility, making Zydus eligible for 180 days of exclusivity for Amantadine capsules.
Fairfax, Bain look to buy Gujarat API company Farmson
Canadian billionaire Prem Watsa's Fairfax Group and Bain Capital are in competition for a buyout of Farmson Basic Drugs, a leading API maker in India valued at ₹4,000 crore. Founded in 1969, Farmson is a major paracetamol manufacturer with a revenue of ₹1,750 crore in FY24. The company's concentrated focus on paracetamol production is a strength, but limited R&D poses challenges for diversification.
Siemens develops Monkeypox RT-PCR testing kit for India, gets CDSCO approval
India has successfully developed its own indigenous RT-PCR testing kit to combat Monkeypox. The kit, created by Siemens Healthineers, has received manufacturing approval from the Central Drugs Standard Control Organisation (CDSCO).
Aurobindo, Glenmark, FDC recall products in US market over manufacturing issues: USFDA
The New Jersey-based Aurobindo Pharma USA Inc initiated the Class 1 recall on July 11, it said. As per the US health regulator, a Class I recall pertains to defective products that can cause serious health problems. Similarly, a US-based subsidiary of Glenmark Pharmaceuticals is recalling 2,404 bottles of Indomethacin Extended-Release Capsules, produced at a Madhya Pradesh plant, due to "Failed Dissolution Specifications", USFDA said.
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.
Shilpa Medicare completes phase-3 trial of novel therapy against nonalcoholic fatty liver disease, shares gain
Shilpa Medicare's shares surged 6.40% on BSE following the successful phase-3 clinical trials of Nor Ursodeoxycholic Acid tablets for Nonalcoholic Fatty Liver Disease. Conducted on 165 patients across India, the trial revealed significant improvements in liver health and reduced fat accumulation with no serious adverse events.
Pharma companies seek more time to implement revised norms on manufacturing practices
Schedule M of the Drugs and Cosmetics Rules, 1945 prescribes the good manufacturing practices (GMP) for pharmaceutical products, such as a prompt product recall system for products known or suspected to be defective. Pharma lobby groups have written to the health minister, seeking an extension of the December 2024 deadline to December 2026, citing lack of resources and challenges faced by the industry in implementing the revised norms.
USFDA pulls up Eugia for manufacturing lapses, data accuracy at Hyderabad plant
The US Food and Drug Administration (USFDA) has issued a warning letter to Eugia Pharma Specialities, a subsidiary of Aurobindo Pharma, citing significant manufacturing issues at its Telangana plant. The USFDA's inspection from January 22 to February 2, 2024, revealed problems including inaccurate production and process simulation data, falsified environmental monitoring records, and incomplete batch production and control records.
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Zydus Lifesciences acquires 50% stake in Sterling Biotech
Zydus Lifesciences entered a joint venture with Perfect Day by acquiring a 50% stake in Sterling Biotech. The collaboration aims to build a manufacturing facility for animal-free protein products, addressing global demand. This venture marks Zydus' entry into the biotech sector, focusing on health and nutrition solutions for lactose-intolerant consumers and those preferring animal-free options.
Govt bans 156 medicines including antibiotics, painkillers, multivitamins: Here is the full list
The Ministry of Health and Family Welfare has banned the manufacture, sale, and distribution of 156 fixed dose combinations. These include treatments for common ailments like colds and fevers. An Expert Committee and the Drugs Technical Advisory Board found no therapeutic justification for these combinations and identified potential health risks, leading to the prohibition.
Govt bans 156 fixed-dose combo drugs over risks
FDCs are medicines that combine two or more drugs into a single dosage. The union health and family welfare ministry on Thursday issued a gazette notification, prohibiting manufacture, sale and distribution of these medicines based on the recommendation of an expert panel that evaluated 324 FDCs.
Alkem Labs diversifies into medical devices biz
Alkem Laboratories has become the first Indian drugmaker to diversify into medical devices after partnering with US-based Exactech to manufacture and market Exactech's joint replacement implants in India. Exactech will provide Alkem MedTech access to its designs, technology, and marketing rights. The endeavor is expected to commercialize in 1-2 years, targeting India's growing orthopaedic market.
Alkem arm ties up with Exactech for knee, hip replacement implants
Alkem Laboratories has announced a partnership through its subsidiary, Alkem MedTech, with US-based Exactech Inc to manufacture and market large joint implants in India. The deal grants Alkem MedTech marketing rights for Exactech's implant brands, including Truliant, Optetrak, and Logic Fit.
USFDA flags Telangana unit of Aurobindo Pharma arm
The letter, issued on August 15, was later made public by the USFDA, which stated that there was failure to ensure the accuracy of data in records for both production and process simulations, i.e. media fills. Media fill is a microbiological test to help prevent contamination during drug production.
