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Glenmark gets USFDA nod for bioequivalent of drug with market size of $21.9 million

Money Control

Money Control · 1y ago

Glenmark gets USFDA nod for bioequivalent of drug with market size of $21.9 million

Glenmark Pharmaceuticals has received final approval from the FDA for its Topiramate Capsules USP, used to treat epilepsy and seizures. The FDA has determined these capsules to be bioequivalent and therapeutic equivalent to a drug by Janssen Pharmaceuticals. The market for Topamax capsules has shown annual sales of around $21.9 million. Glenmark Pharma's US portfolio currently has 198 products authorized for distribution, with 50 ANDAs pending USFDA approval. The company's shares have seen a 65% increase this year and have doubled over the past year, but its consolidated net loss for the March quarter has widened.

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Sacrifices, trade-offs paved big drug win: Glenmark CEO

Livemint

Livemint · 1m ago

Sacrifices, trade-offs paved big drug win: Glenmark CEO

Glenmark Pharmaceuticals' outlicensing deal with AbbVie for a novel blood cancer drug marks a significant step for the company and the Indian pharmaceutical industry. CEO Glenn Saldanha highlights the resilience and sacrifices involved in the innovation process, which ultimately led to success. The partnership reflects a commitment to advancing drug discovery despite the challenges, setting a new course for Glenmark and exemplifying strategic collaboration in the pharmaceutical sector.

Zydus Lifesciences shares - Zydus Lifesciences gets final nod from USFDA for 'Dasatinib' tablets. Details here - Zydus Lifesciences gets final nod from USFDA for 'Dasatinib' tablets

Business Today

Business Today · 5m ago

Zydus Lifesciences shares - Zydus Lifesciences gets final nod from USFDA for 'Dasatinib' tablets. Details here - Zydus Lifesciences gets final nod from USFDA for 'Dasatinib' tablets

Zydus Lifesciences Ltd received final USFDA approval for Dasatinib tablets in various strengths. Dasatinib treats newly diagnosed adults with Philadelphia chromosome-positive chronic myeloid leukaemia (CML) in chronic phase, as well as adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML resistant or intolerant to prior therapy, including imatinib. It also addresses adult patients with Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) showing resistance or intolerance to previous treatments.

India's Glenmark to sell majority stake in life sciences unit for $680 mln

Reuters · 1y ago

India's Glenmark to sell majority stake in life sciences unit for $680 mln

Indian drugmaker Glenmark Pharmaceuticals has announced the sale of a 75% stake in its unit Glenmark Life Sciences to detergent maker Nirma for INR 56.52 billion ($679.84 million). Nirma will purchase the stake at a discount of 1.8% to the unit's current market value. The deal includes a mandatory open offer to all public shareholders of Glenmark Life Sciences. Following the transaction, Glenmark Pharma will retain a 7.84% stake in the company.

Piramal Alternatives invests $13.2 mn in contract drugmaker Biodeal

VCCircle

VCCircle · 1y ago

Piramal Alternatives invests $13.2 mn in contract drugmaker Biodeal

Piramal Alternatives, the fund management arm of Piramal Group, has invested $13.2 million in Biodeal Pharmaceuticals, a contract drugmaker. The investment will be used to enhance infrastructure, expand operations, and establish a dedicated nutraceutical manufacturing facility. Biodeal aims to be ready with a new facility compliant with USFDA accreditations in the next 12-15 months. This capital infusion will also help increase production capacity and introduce innovative solutions, including nasal sprays as drug delivery systems. Piramal Alternatives manages $1.5 billion and specializes in addressing credit gaps in India's mid-market segment.

Neuralink rival Precision gets FDA nod for brain implant component

Inshorts · 4m ago

Neuralink rival Precision gets FDA nod for brain implant component

Elon Musk's Neuralink rival Precision Neuroscience got US Food and Drug Administration approval for its brain implant system's critical part, Layer 7 Cortical Interface, a high-resolution cortical electrode array. "It's used for recording, monitoring, and stimulation of electrical activity on...brain's surface," firm said. "Clearance allows...array to remain implanted for up to 30 days," it added.

ArisInfra Gets SEBI Nod For INR 580 Cr IPO

Inc42 · 9m ago

ArisInfra Gets SEBI Nod For INR 580 Cr IPO

SEBI issued an observation letter to ArisInfra regarding its IPO, cutting the size of the fresh issue to INR 579.60 Cr. ArisInfra is also considering a pre-IPO placement of up to INR 115.92 Cr before filing the Red Herring Prospectus (RHP).

StarBigBloc Building gets shareholders' nod for IPO

Economic Times

Economic Times · 2m ago

StarBigBloc Building gets shareholders' nod for IPO

StarBigBloc Building Material, a subsidiary of BigBloc Construction, has received shareholder approval for an initial public offering (IPO) to raise growth capital and enhance parent company valuation. The IPO will aid in expansion and strengthening the company's market position in India. StarBigBloc aims to boost production capacity from 2.5 lakh cubic meters to over 1.2 million cubic meters annually within 4-5 years and targets revenues of Rs 428 crore by FY28, with an estimated Rs 80 crore profit.

Lupin launches Mirabegron extended-release tablets in US after USFDA nod

Money Control

Money Control · 11m ago

Lupin launches Mirabegron extended-release tablets in US after USFDA nod

Pharmaceutical company Lupin has launched its generic version of Mirabegron extended-release tablets for the treatment of overactive bladder. The US Food and Drug Administration granted approval for the product, which is equivalent to Myrbetriq from Astellas Pharma Global Development. Myrbetriq has estimated annual sales of $1.6 billion in the US. This follows Lupin's recent launch of a generic cancer treatment drug in the US market.

Swiggy gets Sebi nod for proposed $1.25 billion IPO

Economic Times

Economic Times · 11m ago

Swiggy gets Sebi nod for proposed $1.25 billion IPO

Swiggy, the Indian food and grocery delivery platform, has received approval for its $1.25 billion initial public offering (IPO) from the market regulator. Swiggy will file an updated draft red herring prospectus (DRHP) before launching the IPO, which is expected to raise approximately $450 million in fresh capital along with an offer-for-sale component. Major investors like Prosus and SoftBank are likely to sell part of their holdings. Swiggy's main competitor, Zomato, had a successful IPO earlier this year. Swiggy reported revenue of Rs 5,476 crore and a loss of Rs 1,600 crore in the first three quarters of FY24.

Gevra coal mine gets environmental nod for expansion

Livemint

Livemint · 1y ago

Gevra coal mine gets environmental nod for expansion

The Gevra mine in Chhattisgarh, operated by SECL, has received environmental clearance to increase its production capacity to 70 million tonnes per annum. This expansion will make it the largest coal mine in Asia, surpassing Indonesia's Sangatta mine. Currently, Gevra is already the largest coal mine in India, with a production capacity of 52.5 million tonnes per year. The expansion aligns with India's goal of becoming self-sufficient in coal production and reducing its reliance on imports for power generation by FY26. SECL aims to increase its coal production to 200 million tonnes this fiscal year.

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